ALTTO (Adjuvant Lapatinib And/Or Trastuzumab Treatment Optimisation) Study; BIG 2-06/N063D (ALTTO)
March 4, 2025 updated by: Novartis Pharmaceuticals
A Randomised, Multi-centre, Open-label, Phase III Study of Adjuvant Lapatinib, Trastuzumab, Their Sequence and Their Combination in Patients With HER2/ErbB2 Positive Primary Breast Cancer
This was a four-arm (parallel group) randomized, open-label, multicenter Phase 3 study to investigate the use of a combination of Lapatinib and Trastuzumab, a sequence of Trastuzumab followed by Lapatinib, and Lapatinib alone, compared to Trastuzumab alone in the adjuvant treatment of Human Epidermal Growth Factor Receptor 2 (HER2) positive early breast cancer.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Treatment allocation was stratified by blocked randomization, with three stratification factors:
- Hormone receptor status: Estrogen Receptor (ER) and/or Progesterone Receptor (PgR) positive versus both negative.
- Axillary lymph node involvement: not assessed because of neoadjuvant chemotherapy versus node negative versus 1-3 positive nodes versus 4 or more positive nodes.
- Timing of adjuvant chemotherapy: concurrently with taxanes and targeted therapy (Design 2) and concurrently with non-anthracycline-based platinum chemotherapy and targeted therapy (Design 2B) versus all other chemotherapy completed before randomization (Design 1). Treatments delivered differed according to the timing and type of adjuvant chemotherapy.
The primary objective of this study was to compare disease-free survival (DFS) in subjects with HER2 overexpressing and/or amplified breast cancer randomized to trastuzumab for one year versus lapatinib for one year versus trastuzumab (12 or 18 weeks, according to assigned design) followed by a six week treatment-free interval followed by lapatinib (28 or 34 weeks, according to assigned design) versus trastuzumab in combination with lapatinib for one year (52 weeks).
Secondary objectives included treatment comparisons with respect to overall survival, time to recurrence, time to distant recurrence, safety and tolerability, and incidence of brain metastasis.
Based on the recommendation of the Independent Data Monitoring Committee (IDMC) at the first interim analysis (18-Aug-2011), the Lapatinib alone arm was discontinued prior to primary analysis due to futility. The IDMC also stated that the other three arms (trastuzumab alone, sequential trastuzumab/lapatinib arm and the combination arm) could continued as planned with no changes.
Study Type
Interventional
Enrollment (Actual)
8381
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Berazategui, Argentina, B1880BBF
- Novartis Investigative Site
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Ciudad Autonoma de Buenos Aires, Argentina, C1417DTN
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Ciudad Autonoma de Buenos Aires, Argentina, C1125ABD
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Ciudad Autonoma de Buenos Aires, Argentina, C1185AAT
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Mendoza, Argentina, M5500AYB
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Quilmes, Argentina, 1878
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Rosario, Argentina, S2000KZE
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Santa Fe, Argentina, 3000
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Tucuman, Argentina, 4000
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Adelaide, Australia, 5000
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Bedford Park, Australia, 5042
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Bunbury, Australia, 6230
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Campbelltown, Australia, 2560
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Camperdown, Australia, 2050
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Coffs Harbour, Australia, 2450
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Concord, Australia, 2139
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East Bentleigh, Australia, 3165
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East Melbourne, Australia, 3002
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Heidelberg, Australia, 3084
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Hobart, Australia, 7000
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Lismore, Australia, 2480
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Liverpool, Australia, 2170
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Melbourne, Australia, 3002
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Murdoch, Australia, 6150
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Nambour, Australia, 4560
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Nedlands, Australia, 6009
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North Sydney, Australia, 2060
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Parkville, Australia, 3050
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Port Macquarie, Australia, 2444
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Randwick, Australia, 2031
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South Brisbane, Australia, 4101
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Subiaco, Australia, 6008
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Taree, Australia, 2430
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Tweed Heads, Australia, 2485
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Wagga Wagga, Australia, 2650
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Waratah, Australia, 2298
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Wendouree, Australia, 3355
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Westmead, Australia, 2145
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Woodville, Australia, 5011
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Woolloongabba, Australia, 4102
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Victoria
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Box Hill, Victoria, Australia, 3128
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Rankweil, Austria, 6830
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Salzburg, Austria, 5020
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Steyr, Austria, 4400
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Villach, Austria, 9500
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Wien, Austria, 1090
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Aalst, Belgium, 9300
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Antwerpen, Belgium, 2020
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Bonheiden, Belgium, 2820
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Brugge, Belgium, 8000
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Brussels, Belgium, 1000
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Brussels, Belgium, 1070
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Bruxelles, Belgium, 1020
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Bruxelles, Belgium, 1050
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Bruxelles, Belgium, 1200
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Charleroi, Belgium, 6000
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Edegem, Belgium, 2650
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Genk, Belgium, 3600
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Gent, Belgium, 9000
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Haine Saint Paul, Belgium, 7100
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Hasselt, Belgium, 3500
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Huy, Belgium, 4500
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Jette, Belgium, 1090
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Kortrijk, Belgium, 8500
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Leuven, Belgium, 3000
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Liege, Belgium, 4000
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Mons, Belgium, 7000
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Namur, Belgium, 5000
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Roeselare, Belgium, 8800
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Sint-Niklaas, Belgium, 9100
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Tournai, Belgium, 7500
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Turnhout, Belgium, 2300
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Verviers, Belgium, 4800
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Wilrijk, Belgium, 2610
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Yvoir, Belgium, 5530
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Belo Horizonte, Brazil, 30150-270
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Porte Alegre, Brazil, 90430-001
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Porto Alegre, Brazil, 90050-170
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Porto Alegre, Brazil, 90430-090
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Porto Alegre, Brazil, 90560-030
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Porto Alegre, Brazil, 90610000
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Rio de Janeiro, Brazil, 20560-120
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Salvador, Brazil, 40050-410
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Santo Andre, Brazil, 09060-650
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São Paulo
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Jau, São Paulo, Brazil, 17210-120
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Shumen, Bulgaria, 9700
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Sofia, Bulgaria, 1527
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Sofia, Bulgaria, 1756
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Varna, Bulgaria, 9010
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Charlottetown, Canada, C1A 8T5
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Kelowna, Canada, V1Y 5L3
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London, Canada, N6A 4L6
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Moncton, Canada, E1C 8X3
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Regina, Canada, S4T 7T1
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Sault Ste. Marie, Canada, P6A 2C4
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Sherbrooke, Canada, J1H 5N4
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St Catharines, Canada, L2R 7C6
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Vancouver, Canada, V5Z 4E6
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Ontario
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Toronto, Ontario, Canada, M4N 3M5
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Santiago, Chile, 8360160
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Santiago, Chile, 7500921
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Santiago, Chile, 7650635
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Santiago, Chile, 8380455
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Temuco, Chile, 481-0469
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Valdivia, Chile, 5090145
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Valparaiso, Chile, 2341131
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Vina del Mar, Chile, 254-0364
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Beijing, China, 100021
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Beijing, China, 100071
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Guangzhou, China, 510060
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Shanghai, China, 200032
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Tianjin, China, 300060
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Brno, Czechia, 656 53
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Brno, Czechia, 625 00
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Brno, Czechia, 656 91
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Ceske Budejovice, Czechia, 370 87
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Chomutov, Czechia, 43012
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Jihlava, Czechia, 586 01
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Novy Jicin, Czechia, 741 01
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Pardubice, Czechia, 532 03
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Praha 10, Czechia, 100 34
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Praha 2, Czechia, 128 08
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Praha 4, Czechia, 140 59
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Praha 5, Czechia, 150 08
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Praha 8, Czechia, 180 00
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Usti nad Labem, Czechia, 40113
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Aalborg, Denmark, 9100
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Arhus C, Denmark, 8000
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Esbjerg, Denmark, 6700
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Herlev, Denmark, 2730
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Hilleroed, Denmark, 3400
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Koebenhavn Oe, Denmark, 2100
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Naestved, Denmark, 4700
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Odense, Denmark, 5000
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Roskilde, Denmark, 4000
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Vejle, Denmark, 7100
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Viborg, Denmark, 8800
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Tallinn, Estonia, 13419
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Tartu, Estonia, 51014
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Angers, France, 49055
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Annecy, France, 74000
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Avignon, France, 84000
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Bayonne, France, 64100
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Bethune, France, 62400
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Brive La Gaillarde, France, 19100
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Bron, France, 69677
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Caen, France, 14076
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Clermont Ferrand, France, 63000
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Coudekerque Branche, France, 59210
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Dijon, France, 21079
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Draguignan, France, 83007
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Grenoble, France, 38028
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Hyeres, France, 83400
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La Seyne Sur Mer, France, 83500
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Le Mans, France, 72000
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Lille, France, 59000
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Lyon, France, 69008
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Lyon, France, 69337
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Marseille, France, 13273
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Marseille, France, 13285
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Marseille, France, 13385
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Metz, France, 57045
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Mont de Marsan, France, 40024
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Montbeliard, France, 25200
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Nancy, France, 54100
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Nice, France, 06189
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Nimes, France, 30029
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Paris, France, 75475
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Paris, France, 75674
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Paris, France, 75248
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Perigueux, France, 24004
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Perin Sur Mer, France, 22190
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Perpignan, France, 66000
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Reims, France, 51100
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Rouen, France, 76000
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Rouen, France, 76038
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Saint Gregoire, France, 67085
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Saint Jean, France, 31240
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Saint-Cloud, France, 92210
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Saint-Herblain, France, 44805
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Saint-Priest en Jarez, France, 42271
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Strasbourg, France, 67000
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Strasbourg, France, 67085
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Toulouse, France, 31077
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Toulouse, France, 31300
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Tours, France, 37044
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Valenciennes, France, 59322
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Vandoeuvre-Les-Nancy, France, 54511
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Villejuif, France, 94805
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Ansbach, Germany, 91522
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Aschaffenburg, Germany, 63739
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Aschersleben, Germany, 06449
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Aurich, Germany, 26603
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Bad Oldesloe, Germany, 23843
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Bad Reichenhall, Germany, 83435
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Baden-Baden, Germany, 76532
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Bayreuth, Germany, 95445
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Bergisch Gladbach, Germany, 51465
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Berlin, Germany, 10117
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Berlin, Germany, 13125
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Berlin, Germany, 10317
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Berlin, Germany, 10367
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Berlin, Germany, 10967
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Berlin, Germany, 12559
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Berlin, Germany, 13589
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Berlin, Germany, 14169
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Berlin, Germany, 14197
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Bielefeld, Germany, 33604
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Boeblingen, Germany, 71032
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Bonn, Germany, 53127
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Bonn, Germany, 53113
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Bonn, Germany, 53129
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Brandenburg, Germany, 14770
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Braunschweig, Germany, 38100
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Bremen, Germany, 28209
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Bremen, Germany, 28239
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Bremerhaven, Germany, 27574
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Chemnitz, Germany, 09116
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Coburg, Germany, 96450
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Cuxhaven, Germany, 27474
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Dachau, Germany, 85221
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Deggendorf, Germany, 94469
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Donauwoerth, Germany, 86609
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Dresden, Germany, 01307
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Dresden, Germany, 01127
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Duesseldorf, Germany, 40225
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Duesseldorf, Germany, 40325
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Duisburg, Germany, 47166
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Eggenfelden, Germany, 84307
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Erfurt, Germany, 99085
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Erlangen, Germany, 91054
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Eschweiler, Germany, 52249
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Essen, Germany, 45122
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Essen, Germany, 45136
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Essen, Germany, 45130
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Esslingen, Germany, 73730
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Flensburg, Germany, 24939
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Frankfurt, Germany, 60596
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Frankfurt, Germany, 60389
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Frankfurt, Germany, 65929
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Frankfurt am Main, Germany, 60590
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Freiburg, Germany, 79106
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Friedrichshafen, Germany, 88048
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Fuerstenwalde, Germany, 15517
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Fuerth, Germany, 90766
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Garmisch-Partenkirchen, Germany, 82467
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Georgsmarienhuette, Germany, 49124
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Gera, Germany, 07548
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Goeppingen, Germany, 73035
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Goettingen, Germany, 37075
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Goslar, Germany, 38642
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Greifswald, Germany, 17487
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Guestrow, Germany, 18273
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Gummersbach, Germany, 51643
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Halle, Germany, 06120
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Halle, Germany, 06110
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Hamburg, Germany, 20246
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Hamburg, Germany, 20259
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Hamburg, Germany, 20357
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Hamburg, Germany, 22081
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Hamburg, Germany, 22359
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Hamburg, Germany, 22457
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Hameln, Germany, 31785
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Hamm-Heessen, Germany, 59073
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Hannover, Germany, 30177
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Hannover, Germany, 30559
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Heide, Germany, 25746
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Heidelberg, Germany, 69115
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Heidelberg, Germany, 69120
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Herne, Germany, 44623
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Homburg, Germany, 66421
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Hoyerswerda, Germany, 02977
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Itzehoe, Germany, 25524
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Jena, Germany, 07743
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Karlsruhe, Germany, 76199
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Karlsruhe, Germany, 76135
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Kassel, Germany, 34125
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Kassel, Germany, 34117
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Kempten, Germany, 87439
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Kiel, Germany, 24105
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Kiel, Germany, 24103
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Koeln, Germany, 50937
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Koeln, Germany, 50935
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Koeln, Germany, 50677
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Konstanz, Germany, 78464
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Landshut, Germany, 84034
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Landshut, Germany, 84036
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Landstuhl, Germany, 66849
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Leer, Germany, 26789
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Leipzig, Germany, 04277
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Leipzig, Germany, 04129
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Leverkusen, Germany, 51375
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Limburg, Germany, 65549
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Loerrach, Germany, 79539
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Luckenwalde, Germany, 14943
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Ludwigsburg, Germany, 71640
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Ludwigsfelde, Germany, 14974
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Ludwigshafen, Germany, 67063
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Luebeck, Germany, 23538
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Magdeburg, Germany, 39130
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Mainz, Germany, 55131
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Mannheim, Germany, 68165
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Mannheim, Germany, 68167
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Marktredwitz, Germany, 95615
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Meiningen, Germany, 98617
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Memmingen, Germany, 87700
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Minden, Germany, 32429
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Moenchengladbach, Germany, 41061
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Muehlhausen, Germany, 99974
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Muenchen, Germany, 81675
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Muenchen, Germany, 81925
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Muenchen, Germany, 80335
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Muenster, Germany, 48149
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Munchen, Germany, 80638
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Mutlangen, Germany, 73557
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Neumuenster, Germany, 24534
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Neunkirchen, Germany, 66539
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Nuernberg, Germany, 90491
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Offenbach, Germany, 63069
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Oldenburg, Germany, 26121
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Oldenburg, Germany, 26133
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Olpe, Germany, 57462
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Osnabrueck, Germany, 49074
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Ostfildern, Germany, 73760
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Porta Westfalica, Germany, 32457
- Novartis Investigative Site
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Radebeul, Germany, 01445
- Novartis Investigative Site
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Ravensburg, Germany, 88212
- Novartis Investigative Site
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Rendsburg, Germany, 24768
- Novartis Investigative Site
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Reutlingen, Germany, 72764
- Novartis Investigative Site
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Rheinfelden, Germany, 79618
- Novartis Investigative Site
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Rodewisch, Germany, 08228
- Novartis Investigative Site
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Rosenheim, Germany, 83022
- Novartis Investigative Site
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Rostock, Germany, 18059
- Novartis Investigative Site
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Rotenburg, Germany, 27356
- Novartis Investigative Site
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Saarbruecken, Germany, 66113
- Novartis Investigative Site
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Schkeuditz, Germany, 04435
- Novartis Investigative Site
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Schwaebisch Hall, Germany, 74523
- Novartis Investigative Site
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Sigmaringen, Germany, 72488
- Novartis Investigative Site
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Stade, Germany, 21680
- Novartis Investigative Site
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Stadthagen, Germany, 31655
- Novartis Investigative Site
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Stendal, Germany, 39576
- Novartis Investigative Site
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Stralsund, Germany, 18435
- Novartis Investigative Site
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Stuttgart, Germany, 70174
- Novartis Investigative Site
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Stuttgart, Germany, 70376
- Novartis Investigative Site
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Torgau, Germany, 04860
- Novartis Investigative Site
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Trier, Germany, 54290
- Novartis Investigative Site
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Troisdorf, Germany, 53840
- Novartis Investigative Site
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Tuebingen, Germany, 72076
- Novartis Investigative Site
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Ulm, Germany, 89075
- Novartis Investigative Site
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Vechta, Germany, 49377
- Novartis Investigative Site
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Velbert, Germany, 42551
- Novartis Investigative Site
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Villingen-Schwenningen, Germany, 78050
- Novartis Investigative Site
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Weissenfels, Germany, 06667
- Novartis Investigative Site
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Wesel, Germany, 46485
- Novartis Investigative Site
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Westerstede, Germany, 26655
- Novartis Investigative Site
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Wiesbaden, Germany, 65191
- Novartis Investigative Site
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Wiesbaden, Germany, 65199
- Novartis Investigative Site
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Wiesbaden, Germany, 65189
- Novartis Investigative Site
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Witten, Germany, 58452
- Novartis Investigative Site
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Wuerselen, Germany, 52146
- Novartis Investigative Site
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Wuerzburg, Germany, 97080
- Novartis Investigative Site
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Wuppertal, Germany, 42105
- Novartis Investigative Site
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Wuppertal, Germany, 42283
- Novartis Investigative Site
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Zittau, Germany, 02763
- Novartis Investigative Site
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Zwickau, Germany, 08060
- Novartis Investigative Site
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Athens, Greece, 11527
- Novartis Investigative Site
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Athens, Greece, 15123
- Novartis Investigative Site
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Athens, Greece, 18547
- Novartis Investigative Site
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Athens, Greece, 11522
- Novartis Investigative Site
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Heraklion, Greece, 71110
- Novartis Investigative Site
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Patra, Greece, 26504
- Novartis Investigative Site
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Thessaloniki, Greece, 546 45
- Novartis Investigative Site
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Kowloon, Hong Kong
- Novartis Investigative Site
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Tuen Mun, Hong Kong
- Novartis Investigative Site
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Budapest, Hungary, 1032
- Novartis Investigative Site
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Budapest, Hungary, 1082
- Novartis Investigative Site
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Budapest, Hungary, 1145
- Novartis Investigative Site
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Budapest, Hungary, 1122
- Novartis Investigative Site
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Gyor, Hungary, 9023
- Novartis Investigative Site
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Szeged, Hungary, 6720
- Novartis Investigative Site
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Gurgaon, India, 122002
- Novartis Investigative Site
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Hyderabad, India, 500082
- Novartis Investigative Site
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Kolkatta, India, 700016
- Novartis Investigative Site
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Mumbai, India, 400012
- Novartis Investigative Site
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Nagpur, India, 440010
- Novartis Investigative Site
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New Delhi, India, 110029
- Novartis Investigative Site
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New Delhi, India, 110076
- Novartis Investigative Site
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Trivandrum, India, 695011
- Novartis Investigative Site
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Cork, Ireland
- Novartis Investigative Site
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Dublin, Ireland, 7
- Novartis Investigative Site
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Dublin, Ireland, 8
- Novartis Investigative Site
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Dublin, Ireland, 9
- Novartis Investigative Site
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Dublin, Ireland, 24
- Novartis Investigative Site
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Galway, Ireland
- Novartis Investigative Site
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Beer-Sheva, Israel, 84101
- Novartis Investigative Site
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Haifa, Israel, 31096
- Novartis Investigative Site
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Holon, Israel, 58100
- Novartis Investigative Site
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Jerusalem, Israel, 91031
- Novartis Investigative Site
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Netanya, Israel, 52621
- Novartis Investigative Site
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Ramat Gan, Israel, 52621
- Novartis Investigative Site
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Tel Aviv, Israel, 64239
- Novartis Investigative Site
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Zrifin, Israel, 70300
- Novartis Investigative Site
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Asti, Italy, 14100
- Novartis Investigative Site
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Avellino, Italy, 83100
- Novartis Investigative Site
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Aviano, Italy, 33081
- Novartis Investigative Site
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Bergamo, Italy, 24127
- Novartis Investigative Site
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Biella, Italy, 13900
- Novartis Investigative Site
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Brescia, Italy, 25123
- Novartis Investigative Site
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Brescia, Italy, 25124
- Novartis Investigative Site
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Brindisi, Italy, 72100
- Novartis Investigative Site
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Candiolo, Italy, 10060
- Novartis Investigative Site
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Carpi, Italy, 41012
- Novartis Investigative Site
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Cosenza, Italy, 87100
- Novartis Investigative Site
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Cremona, Italy, 26100
- Novartis Investigative Site
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Fano, Italy, 61032
- Novartis Investigative Site
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Fermo, Italy, 63023
- Novartis Investigative Site
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Firenze, Italy, 50134
- Novartis Investigative Site
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Genova, Italy, 16132
- Novartis Investigative Site
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Lecce, Italy, 73100
- Novartis Investigative Site
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Lecco, Italy, 23900
- Novartis Investigative Site
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Lido di Camaiore, Italy, 55043
- Novartis Investigative Site
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Livorno, Italy, 57123
- Novartis Investigative Site
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Mantova, Italy, 46100
- Novartis Investigative Site
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Meldola, Italy, 47014
- Novartis Investigative Site
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Milano, Italy, 20142
- Novartis Investigative Site
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Milano, Italy, 20162
- Novartis Investigative Site
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Monserrato, Italy, 09042
- Novartis Investigative Site
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Monza, Italy, 20052
- Novartis Investigative Site
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Pavia, Italy, 27100
- Novartis Investigative Site
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Poggibonsi, Italy, 53036
- Novartis Investigative Site
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Potenza, Italy, 85100
- Novartis Investigative Site
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Prato, Italy, 59100
- Novartis Investigative Site
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Ragusa, Italy, 97100
- Novartis Investigative Site
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Ravenna, Italy, 48100
- Novartis Investigative Site
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Rimini, Italy, 47900
- Novartis Investigative Site
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Rozzano, Italy, 20089
- Novartis Investigative Site
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San Fermo della Battaglia, Italy, 22020
- Novartis Investigative Site
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Saronno, Italy, 21047
- Novartis Investigative Site
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Sassari, Italy, 07100
- Novartis Investigative Site
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Trento, Italy, 38122
- Novartis Investigative Site
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Treviglio, Italy, 24027
- Novartis Investigative Site
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Udine, Italy, 33100
- Novartis Investigative Site
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Varese, Italy, 21100
- Novartis Investigative Site
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Viterbo, Italy, 01100
- Novartis Investigative Site
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Aichi, Japan, 464-8681
- Novartis Investigative Site
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Chiba, Japan, 277-8577
- Novartis Investigative Site
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Ehime, Japan, 791-0280
- Novartis Investigative Site
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Fukuoka, Japan, 811-1395
- Novartis Investigative Site
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Ibaraki, Japan, 305-8576
- Novartis Investigative Site
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Kanagawa, Japan, 259-1143
- Novartis Investigative Site
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Kyoto, Japan, 606-8507
- Novartis Investigative Site
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Osaka, Japan, 530-8480
- Novartis Investigative Site
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Osaka, Japan, 540-0006
- Novartis Investigative Site
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Saitama, Japan, 350-1298
- Novartis Investigative Site
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Tokyo, Japan, 104-0045
- Novartis Investigative Site
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Tokyo, Japan, 101-8643
- Novartis Investigative Site
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Tokyo, Japan, 104-8560
- Novartis Investigative Site
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Tokyo, Japan, 113-8677
- Novartis Investigative Site
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Tokyo, Japan, 135-8550
- Novartis Investigative Site
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Gyeonggi-do, Korea, Republic of, 10408
- Novartis Investigative Site
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Gyeonggi-do, Korea, Republic of, 443-380
- Novartis Investigative Site
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Incheon, Korea, Republic of, 400-711
- Novartis Investigative Site
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Seoul, Korea, Republic of, 03080
- Novartis Investigative Site
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Seoul, Korea, Republic of, 003722
- Novartis Investigative Site
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Seoul, Korea, Republic of, 06351
- Novartis Investigative Site
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Seoul, Korea, Republic of, 138-736
- Novartis Investigative Site
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Chihuahua, Mexico, 31000
- Novartis Investigative Site
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Mexico, Mexico, 11000
- Novartis Investigative Site
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Mexico City, Mexico, 14080
- Novartis Investigative Site
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Toluca, Mexico, 50080
- Novartis Investigative Site
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Amsterdam, Netherlands, 1081 HV
- Novartis Investigative Site
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Arnhem, Netherlands, 6815 AD
- Novartis Investigative Site
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Delft, Netherlands, 2625 AD
- Novartis Investigative Site
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Den Haag, Netherlands, 2512 VA
- Novartis Investigative Site
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Den Haag, Netherlands, 2545 CH
- Novartis Investigative Site
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Eindhoven, Netherlands, 5623 EJ
- Novartis Investigative Site
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Gouda, Netherlands, 2803 HH
- Novartis Investigative Site
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Hilversum, Netherlands, 1213 XZ
- Novartis Investigative Site
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Hoogeveen, Netherlands, 7909 AA
- Novartis Investigative Site
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Leeuwarden, Netherlands, 8934 AD
- Novartis Investigative Site
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Leiden, Netherlands, 2333 ZA
- Novartis Investigative Site
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Leidschendam, Netherlands, 2262 BA
- Novartis Investigative Site
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Purmerend, Netherlands, 1441 RN
- Novartis Investigative Site
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Rotterdam, Netherlands, 3083 AN
- Novartis Investigative Site
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Sittard-Geleen, Netherlands, 6162 BG
- Novartis Investigative Site
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Tilburg, Netherlands, 5022 GC
- Novartis Investigative Site
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Utrecht, Netherlands, 3582 KE
- Novartis Investigative Site
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Hamilton, New Zealand, 2001
- Novartis Investigative Site
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Palmerston North, New Zealand, 4414
- Novartis Investigative Site
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Wellington, New Zealand, 6021
- Novartis Investigative Site
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Oslo, Norway, 0310
- Novartis Investigative Site
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Oslo, Norway, 0407
- Novartis Investigative Site
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Tromso, Norway, 9038
- Novartis Investigative Site
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Karachi, Pakistan, 74800
- Novartis Investigative Site
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Karachi, Pakistan
- Novartis Investigative Site
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Lahore, Pakistan, 53400
- Novartis Investigative Site
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Lahore, Pakistan, 54600
- Novartis Investigative Site
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Rawalpindi, Pakistan, 1590
- Novartis Investigative Site
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Callao, Peru, Callao 2
- Novartis Investigative Site
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Lima, Peru, 13
- Novartis Investigative Site
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Lima, Peru, 11
- Novartis Investigative Site
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Lima, Peru, 34
- Novartis Investigative Site
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Cebu, Philippines, 6000
- Novartis Investigative Site
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Quezon City, Philippines, 1102
- Novartis Investigative Site
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Sampaloc, Philippines, 1008
- Novartis Investigative Site
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San Juan, Philippines, 1502
- Novartis Investigative Site
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Bydgoszcz, Poland, 85-796
- Novartis Investigative Site
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Gdansk, Poland, 80-210
- Novartis Investigative Site
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Gdansk, Poland, 80-214
- Novartis Investigative Site
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Gliwice, Poland, 44-101
- Novartis Investigative Site
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Krakow, Poland, 31-115
- Novartis Investigative Site
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Olsztyn, Poland, 10-226
- Novartis Investigative Site
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Olsztyn, Poland, 10-228
- Novartis Investigative Site
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Opole, Poland, 45-060
- Novartis Investigative Site
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Rzeszow, Poland, 35-021
- Novartis Investigative Site
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Szczecin, Poland, 71-730
- Novartis Investigative Site
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Warszawa, Poland, 02-781
- Novartis Investigative Site
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Wroclaw, Poland, 53-413
- Novartis Investigative Site
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Bucharest, Romania, 022328
- Novartis Investigative Site
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Bucharest, Romania, 050098
- Novartis Investigative Site
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Bucuresti, Romania, 022328
- Novartis Investigative Site
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Cluj-Napoca, Romania, 400015
- Novartis Investigative Site
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Iasi, Romania, 700106
- Novartis Investigative Site
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Arkhangelsk, Russian Federation, 163045
- Novartis Investigative Site
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Chelyabinsk, Russian Federation, 454087
- Novartis Investigative Site
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Irkutsk, Russian Federation, 664035
- Novartis Investigative Site
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Kazan, Russian Federation, 420029
- Novartis Investigative Site
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Kirov, Russian Federation, 610021
- Novartis Investigative Site
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Moscow, Russian Federation, 115478
- Novartis Investigative Site
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Moscow, Russian Federation, 121359
- Novartis Investigative Site
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Novosibirsk, Russian Federation, 630047
- Novartis Investigative Site
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Omsk, Russian Federation, 644013
- Novartis Investigative Site
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Orenburg, Russian Federation, 460021
- Novartis Investigative Site
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Ryazan, Russian Federation, 390011
- Novartis Investigative Site
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Samara, Russian Federation, 443031
- Novartis Investigative Site
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St. Petersburg, Russian Federation, 197758
- Novartis Investigative Site
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St. Petersburg, Russian Federation, 197022
- Novartis Investigative Site
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Voronezh, Russian Federation, 394062
- Novartis Investigative Site
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Singapore, Singapore, 119082
- Novartis Investigative Site
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Bratislava, Slovakia, 812 50
- Novartis Investigative Site
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Bratislava, Slovakia, 833 10
- Novartis Investigative Site
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Kosice, Slovakia, 041 91
- Novartis Investigative Site
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Poprad, Slovakia, 058 01
- Novartis Investigative Site
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Zilina, Slovakia, 010 01
- Novartis Investigative Site
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Ljubljana, Slovenia, 1000
- Novartis Investigative Site
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Capital Park, South Africa, 0002
- Novartis Investigative Site
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Groenkloof, South Africa, 0081
- Novartis Investigative Site
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Johannesburg, South Africa, 2199
- Novartis Investigative Site
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Observatory, South Africa, 7925
- Novartis Investigative Site
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Panorama, South Africa, 7500
- Novartis Investigative Site
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Parktown, South Africa, 2193
- Novartis Investigative Site
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Pretoria, South Africa, 0081
- Novartis Investigative Site
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Alcoy, Spain, 03804
- Novartis Investigative Site
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Barcelona, Spain, 08035
- Novartis Investigative Site
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Barcelona, Spain, 08907
- Novartis Investigative Site
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Burgos, Spain, 09006
- Novartis Investigative Site
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Cadiz, Spain, 11009
- Novartis Investigative Site
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Castellon, Spain, 12002
- Novartis Investigative Site
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Cordoba, Spain, 14004
- Novartis Investigative Site
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Elda, Spain, 03600
- Novartis Investigative Site
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Granada, Spain, 18014
- Novartis Investigative Site
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Lerida, Spain, 25198
- Novartis Investigative Site
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Lugo, Spain, 27003
- Novartis Investigative Site
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Madrid, Spain, 28041
- Novartis Investigative Site
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Madrid, Spain, 28046
- Novartis Investigative Site
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Madrid, Spain, 28006
- Novartis Investigative Site
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Madrid, Spain, 28007
- Novartis Investigative Site
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Madrid, Spain, 28033
- Novartis Investigative Site
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Madrid, Spain, 28460
- Novartis Investigative Site
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Malaga, Spain, 29010
- Novartis Investigative Site
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Mataro, Spain, 08034
- Novartis Investigative Site
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Mostoles, Spain, 28460
- Novartis Investigative Site
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Murcia, Spain, 30008
- Novartis Investigative Site
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Palma de Mallorca, Spain, 07198
- Novartis Investigative Site
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Palma de Mallorca, Spain, 07010
- Novartis Investigative Site
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Pamplona, Spain, 31008
- Novartis Investigative Site
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Salamanca, Spain, 37007
- Novartis Investigative Site
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San Sebastian, Spain, 20014
- Novartis Investigative Site
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Santa Cruz de Tenerife, Spain, 38320
- Novartis Investigative Site
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Santander, Spain, 39008
- Novartis Investigative Site
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Santiago, Spain, 15705
- Novartis Investigative Site
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Segovia, Spain, 40002
- Novartis Investigative Site
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Sevilla, Spain, 41014
- Novartis Investigative Site
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Sevilla, Spain, 41009
- Novartis Investigative Site
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Tarrasa, Barcelona, Spain, 08221
- Novartis Investigative Site
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Toledo, Spain, 45004
- Novartis Investigative Site
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Valencia, Spain, 46014
- Novartis Investigative Site
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Vizcaya, Spain, 48903
- Novartis Investigative Site
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Zamora, Spain
- Novartis Investigative Site
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Aarau, Switzerland, 5001
- Novartis Investigative Site
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Basel, Switzerland, 4031
- Novartis Investigative Site
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Bellinzona, Switzerland, 6500
- Novartis Investigative Site
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Chur, Switzerland, 7000
- Novartis Investigative Site
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Lausanne, Switzerland, 1005
- Novartis Investigative Site
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Locarno, Switzerland, 6600
- Novartis Investigative Site
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St Gallen, Switzerland, 9007
- Novartis Investigative Site
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Thun, Switzerland, 3600
- Novartis Investigative Site
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Zuerich, Switzerland, 8091
- Novartis Investigative Site
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Zurich, Switzerland, 8008
- Novartis Investigative Site
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Kaohsiung, Taiwan, 807
- Novartis Investigative Site
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Taichung, Taiwan, 404
- Novartis Investigative Site
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Tainan County, Taiwan, 736
- Novartis Investigative Site
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Taipei, Taiwan, 100
- Novartis Investigative Site
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Taipei, Taiwan, 104
- Novartis Investigative Site
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Taipei, Taiwan, 105
- Novartis Investigative Site
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Taipei, Taiwan, 112
- Novartis Investigative Site
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Taipei, Taiwan, 114
- Novartis Investigative Site
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Bangkok, Thailand, 10330
- Novartis Investigative Site
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Bangkok, Thailand, 10700
- Novartis Investigative Site
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Bangkok, Thailand, 10400
- Novartis Investigative Site
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Chiangmai, Thailand, 50200
- Novartis Investigative Site
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Khon Kaen, Thailand, 40002
- Novartis Investigative Site
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Phitsanulok, Thailand, 65000
- Novartis Investigative Site
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Songkhla, Thailand, 90110
- Novartis Investigative Site
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Chernivtsi, Ukraine, 58013
- Novartis Investigative Site
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Donetsk, Ukraine, 83092
- Novartis Investigative Site
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Kharkiv, Ukraine, 61024
- Novartis Investigative Site
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Kyiv, Ukraine, 03115
- Novartis Investigative Site
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Lviv, Ukraine, 79031
- Novartis Investigative Site
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Simferopol, Ukraine, 95023
- Novartis Investigative Site
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Uzhgorod, Ukraine, 88014
- Novartis Investigative Site
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Uzhorod, Ukraine, 88000
- Novartis Investigative Site
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Blackpool, United Kingdom, FY3 8NR
- Novartis Investigative Site
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Bournemouth, United Kingdom, BH7 7DW
- Novartis Investigative Site
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Brighton, United Kingdom, BN2 5BE
- Novartis Investigative Site
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Cardiff, United Kingdom, CF14 2TL
- Novartis Investigative Site
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Chelmsford, United Kingdom, CM1 7ET
- Novartis Investigative Site
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Cheltenham, United Kingdom, GL53 7AN
- Novartis Investigative Site
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Cottingham, United Kingdom, HU16 5JQ
- Novartis Investigative Site
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Dorchester, United Kingdom, DT1 2JY
- Novartis Investigative Site
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Edinburgh, United Kingdom, EH4 2XU
- Novartis Investigative Site
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Exeter, United Kingdom, EX2 5DW
- Novartis Investigative Site
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Grimsby, United Kingdom, DN33 2BA
- Novartis Investigative Site
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Guildford, United Kingdom, GU2 7XX
- Novartis Investigative Site
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Gwynedd, United Kingdom, LL57 2PW
- Novartis Investigative Site
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Huddersfield, United Kingdom, HD3 3EA
- Novartis Investigative Site
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Ipswich, United Kingdom, IP4 5PD
- Novartis Investigative Site
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Lancaster, United Kingdom, LA1 4RP
- Novartis Investigative Site
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Leeds, United Kingdom, LS9 7TF
- Novartis Investigative Site
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Liverpool, United Kingdom, L7 8XP
- Novartis Investigative Site
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London, United Kingdom, EC1A 7BE
- Novartis Investigative Site
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London, United Kingdom, NW1 2PG
- Novartis Investigative Site
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London, United Kingdom, SW17 0QT
- Novartis Investigative Site
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London, United Kingdom, W2 1NY
- Novartis Investigative Site
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London, United Kingdom, W6 8RF
- Novartis Investigative Site
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Maidstone, United Kingdom, ME16 9QQ
- Novartis Investigative Site
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Manchester, United Kingdom, M20 4BX
- Novartis Investigative Site
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Newcastle upon Tyne, United Kingdom, NE7 7DN
- Novartis Investigative Site
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Northwood, United Kingdom, HA6 2RN
- Novartis Investigative Site
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Nottingham, United Kingdom, NG5 1PB
- Novartis Investigative Site
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Oxford, United Kingdom, OX3 7LJ
- Novartis Investigative Site
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Plymouth, United Kingdom, PL6 8DH
- Novartis Investigative Site
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Poole, United Kingdom, BH15 2JB
- Novartis Investigative Site
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Portsmouth, United Kingdom, PO6 3LY
- Novartis Investigative Site
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Preston, United Kingdom, PR2 9HT
- Novartis Investigative Site
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Prittlewell Chase, United Kingdom, SS0 0RY
- Novartis Investigative Site
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Romford, United Kingdom, RM7 0AG
- Novartis Investigative Site
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Sheffield, United Kingdom, S10 2SJ
- Novartis Investigative Site
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Shrewsbury, United Kingdom, SY3 8XQ
- Novartis Investigative Site
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St Helens, United Kingdom, WA9 3DA
- Novartis Investigative Site
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Stoke on Trent, United Kingdom, ST4 6QG
- Novartis Investigative Site
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Sutton, United Kingdom, SM2 5PT
- Novartis Investigative Site
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Swansea, United Kingdom, SA2 8QA
- Novartis Investigative Site
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Worthing, United Kingdom, BN11 2DH
- Novartis Investigative Site
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Kent
-
Canterbury, Kent, United Kingdom, CT1 3NG
- Novartis Investigative Site
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Alabama
-
Mobile, Alabama, United States, 36608
- Novartis Investigative Site
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Alaska
-
Anchorage, Alaska, United States, 99508
- Novartis Investigative Site
-
-
Arizona
-
Tucson, Arizona, United States, 85715
- Novartis Investigative Site
-
-
Arkansas
-
Jonesboro, Arkansas, United States, 72401
- Novartis Investigative Site
-
-
California
-
Duarte, California, United States, 91010
- Novartis Investigative Site
-
Fairfield, California, United States, 94533
- Novartis Investigative Site
-
La Jolla, California, United States, 92093-0987
- Novartis Investigative Site
-
La Jolla, California, United States, 92093
- Novartis Investigative Site
-
Loma Linda, California, United States, 92534
- Novartis Investigative Site
-
Martinez, California, United States, 94553-3156
- Novartis Investigative Site
-
Marysville, California, United States, 95901
- Novartis Investigative Site
-
Mountain View, California, United States, 94040
- Novartis Investigative Site
-
Oakland, California, United States, 94609
- Novartis Investigative Site
-
Pleasanton, California, United States, 94588
- Novartis Investigative Site
-
Sacramento, California, United States, 95817
- Novartis Investigative Site
-
San Francisco, California, United States, 94110
- Novartis Investigative Site
-
-
Colorado
-
Aurora, Colorado, United States, 80012
- Novartis Investigative Site
-
Boulder, Colorado, United States, 80301
- Novartis Investigative Site
-
Colorado Springs, Colorado, United States, 80907
- Novartis Investigative Site
-
Denver, Colorado, United States, 80210
- Novartis Investigative Site
-
Denver, Colorado, United States, 80218
- Novartis Investigative Site
-
Denver, Colorado, United States, 80220
- Novartis Investigative Site
-
Fort Collins, Colorado, United States, 80524
- Novartis Investigative Site
-
Fort Collins, Colorado, United States, 80528
- Novartis Investigative Site
-
Thornton, Colorado, United States, 80229
- Novartis Investigative Site
-
Wheat Ridge, Colorado, United States, 80033
- Novartis Investigative Site
-
-
Connecticut
-
Hartford, Connecticut, United States, 06105
- Novartis Investigative Site
-
New Haven, Connecticut, United States, 06520
- Novartis Investigative Site
-
-
Delaware
-
Dover, Delaware, United States, 19901
- Novartis Investigative Site
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20007
- Novartis Investigative Site
-
Washington, District of Columbia, United States, 20307
- Novartis Investigative Site
-
-
Florida
-
Boca Raton, Florida, United States, 33486
- Novartis Investigative Site
-
Fort Lauderdale, Florida, United States, 33308
- Novartis Investigative Site
-
Fort Myers, Florida, United States, 33916
- Novartis Investigative Site
-
Hollywood, Florida, United States, 33021
- Novartis Investigative Site
-
Jacksonville, Florida, United States, 32207
- Novartis Investigative Site
-
Jacksonville, Florida, United States, 32224
- Novartis Investigative Site
-
Lakeland, Florida, United States, 33805
- Novartis Investigative Site
-
Ocala, Florida, United States, 34474
- Novartis Investigative Site
-
Orlando, Florida, United States, 32806
- Novartis Investigative Site
-
Orlando, Florida, United States, 32803
- Novartis Investigative Site
-
Weston, Florida, United States, 33331
- Novartis Investigative Site
-
-
Georgia
-
Athens, Georgia, United States, 30607
- Novartis Investigative Site
-
Atlanta, Georgia, United States, 30309
- Novartis Investigative Site
-
Atlanta, Georgia, United States, 30342
- Novartis Investigative Site
-
Augusta, Georgia, United States, 30912
- Novartis Investigative Site
-
Columbus, Georgia, United States, 31904
- Novartis Investigative Site
-
Decatur, Georgia, United States, 30033
- Novartis Investigative Site
-
Savannah, Georgia, United States, 31405
- Novartis Investigative Site
-
-
Hawaii
-
Honolulu, Hawaii, United States, 96813
- Novartis Investigative Site
-
Honolulu, Hawaii, United States, 96859
- Novartis Investigative Site
-
Lihue, Hawaii, United States, 96766
- Novartis Investigative Site
-
-
Idaho
-
Boise, Idaho, United States, 83706
- Novartis Investigative Site
-
Boise, Idaho, United States, 83712
- Novartis Investigative Site
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Novartis Investigative Site
-
Evanston, Illinois, United States, 60201
- Novartis Investigative Site
-
Harvey, Illinois, United States, 60426
- Novartis Investigative Site
-
Kankakee, Illinois, United States, 60901
- Novartis Investigative Site
-
Maywood, Illinois, United States, 60153
- Novartis Investigative Site
-
Mount Vernon, Illinois, United States, 62864
- Novartis Investigative Site
-
Oak Lawn, Illinois, United States, 60453-2699
- Novartis Investigative Site
-
Ottawa, Illinois, United States, 61350
- Novartis Investigative Site
-
Pekin, Illinois, United States, 61554
- Novartis Investigative Site
-
Peoria, Illinois, United States, 61615
- Novartis Investigative Site
-
Peru, Illinois, United States, 61354
- Novartis Investigative Site
-
Princeton, Illinois, United States, 61356
- Novartis Investigative Site
-
Rockford, Illinois, United States, 61114
- Novartis Investigative Site
-
Rockford, Illinois, United States, 61104
- Novartis Investigative Site
-
Skokie, Illinois, United States, 60077
- Novartis Investigative Site
-
Springfield, Illinois, United States, 62781-0001
- Novartis Investigative Site
-
Urbana, Illinois, United States, 61801
- Novartis Investigative Site
-
-
Indiana
-
Beech Grove, Indiana, United States, 46107
- Novartis Investigative Site
-
Fort Wayne, Indiana, United States, 46815
- Novartis Investigative Site
-
Indianapolis, Indiana, United States, 46202
- Novartis Investigative Site
-
Kokomo, Indiana, United States, 46904
- Novartis Investigative Site
-
Mishawaka, Indiana, United States, 46545
- Novartis Investigative Site
-
Muncie, Indiana, United States, 47303
- Novartis Investigative Site
-
South Bend, Indiana, United States, 46601
- Novartis Investigative Site
-
South Bend, Indiana, United States, 46617
- Novartis Investigative Site
-
-
Iowa
-
Ames, Iowa, United States, 50010
- Novartis Investigative Site
-
Bettendorf, Iowa, United States, 52722
- Novartis Investigative Site
-
Cedar Rapids, Iowa, United States, 52402
- Novartis Investigative Site
-
Des Moines, Iowa, United States, 50309
- Novartis Investigative Site
-
Des Moines, Iowa, United States, 50314
- Novartis Investigative Site
-
Mason City, Iowa, United States
- Novartis Investigative Site
-
Sioux City, Iowa, United States, 51101-1733
- Novartis Investigative Site
-
Waterloo, Iowa, United States, 50702
- Novartis Investigative Site
-
-
Kansas
-
Chanute, Kansas, United States, 66720
- Novartis Investigative Site
-
El Dorado, Kansas, United States, 67042
- Novartis Investigative Site
-
Independence, Kansas, United States, 67301
- Novartis Investigative Site
-
Lawrence, Kansas, United States, 66044
- Novartis Investigative Site
-
Prairie Village, Kansas, United States, 66208
- Novartis Investigative Site
-
Pratt, Kansas, United States, 67124
- Novartis Investigative Site
-
Topeka, Kansas, United States, 66604
- Novartis Investigative Site
-
Topeka, Kansas, United States, 66606
- Novartis Investigative Site
-
Wichita, Kansas, United States, 67214
- Novartis Investigative Site
-
-
Kentucky
-
Louisville, Kentucky, United States, 40292
- Novartis Investigative Site
-
-
Louisiana
-
Baton Rouge, Louisiana, United States, 70809
- Novartis Investigative Site
-
New Orleans, Louisiana, United States, 70112
- Novartis Investigative Site
-
New Orleans, Louisiana, United States, 70121
- Novartis Investigative Site
-
-
Maine
-
Portland, Maine, United States, 04101
- Novartis Investigative Site
-
Scarborough, Maine, United States, 04074
- Novartis Investigative Site
-
-
Maryland
-
Baltimore, Maryland, United States, 21201
- Novartis Investigative Site
-
Baltimore, Maryland, United States, 21287-8936
- Novartis Investigative Site
-
Bethesda, Maryland, United States, 20889-5600
- Novartis Investigative Site
-
Frederick, Maryland, United States, 21701
- Novartis Investigative Site
-
Silver Spring, Maryland, United States, 20910
- Novartis Investigative Site
-
Towson, Maryland, United States, 21204
- Novartis Investigative Site
-
Westminster, Maryland, United States, 21157
- Novartis Investigative Site
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02135
- Novartis Investigative Site
-
Hyannis, Massachusetts, United States, 02601
- Novartis Investigative Site
-
Peabody, Massachusetts, United States, 01960
- Novartis Investigative Site
-
-
Michigan
-
Adrian, Michigan, United States, 49221
- Novartis Investigative Site
-
Ann Arbor, Michigan, United States, 48106-0995
- Novartis Investigative Site
-
Dearborn, Michigan, United States, 48123
- Novartis Investigative Site
-
Detroit, Michigan, United States, 48202
- Novartis Investigative Site
-
Flint, Michigan, United States, 48532
- Novartis Investigative Site
-
Iron Mountain, Michigan, United States, 49801
- Novartis Investigative Site
-
Kalamazoo, Michigan, United States, 49007
- Novartis Investigative Site
-
Pontiac, Michigan, United States, 48341-2985
- Novartis Investigative Site
-
Saginaw, Michigan, United States, 48601
- Novartis Investigative Site
-
Saint Joseph, Michigan, United States, 49085
- Novartis Investigative Site
-
Southfield, Michigan, United States, 48075
- Novartis Investigative Site
-
-
Minnesota
-
Albert Lea, Minnesota, United States, 56007
- Novartis Investigative Site
-
Duluth, Minnesota, United States, 55805
- Novartis Investigative Site
-
Edina, Minnesota, United States, 55435
- Novartis Investigative Site
-
Mankato, Minnesota, United States, 56002
- Novartis Investigative Site
-
Maplewood, Minnesota, United States, 55109
- Novartis Investigative Site
-
Minneapolis, Minnesota, United States, 55407-3799
- Novartis Investigative Site
-
Minneapolis, Minnesota, United States, 55415
- Novartis Investigative Site
-
Saint Cloud, Minnesota, United States, 56303
- Novartis Investigative Site
-
Saint Louis Park, Minnesota, United States, 55416
- Novartis Investigative Site
-
Saint Paul, Minnesota, United States, 55101
- Novartis Investigative Site
-
Saint Paul, Minnesota, United States, 55102
- Novartis Investigative Site
-
Shakopee, Minnesota, United States, 55379
- Novartis Investigative Site
-
Waconia, Minnesota, United States, 55387
- Novartis Investigative Site
-
Willmar, Minnesota, United States, 56201
- Novartis Investigative Site
-
-
Mississippi
-
Pascagoula, Mississippi, United States, 39581
- Novartis Investigative Site
-
-
Missouri
-
Kansas City, Missouri, United States, 64131
- Novartis Investigative Site
-
Saint Louis, Missouri, United States, 63110
- Novartis Investigative Site
-
Springfield, Missouri, United States, 65807
- Novartis Investigative Site
-
-
Montana
-
Billings, Montana, United States, 59101
- Novartis Investigative Site
-
Bozeman, Montana, United States, 59715
- Novartis Investigative Site
-
Great Falls, Montana, United States, 59405
- Novartis Investigative Site
-
-
Nebraska
-
Grand Island, Nebraska, United States, 68803
- Novartis Investigative Site
-
Lincoln, Nebraska, United States, 68510
- Novartis Investigative Site
-
Omaha, Nebraska, United States, 68106
- Novartis Investigative Site
-
Omaha, Nebraska, United States, 68114
- Novartis Investigative Site
-
Omaha, Nebraska, United States, 68122
- Novartis Investigative Site
-
Omaha, Nebraska, United States, 68124
- Novartis Investigative Site
-
Omaha, Nebraska, United States, 68131
- Novartis Investigative Site
-
Omaha, Nebraska, United States, 68198
- Novartis Investigative Site
-
-
Nevada
-
Las Vegas, Nevada, United States, 89169
- Novartis Investigative Site
-
-
New Hampshire
-
Concord, New Hampshire, United States, 03301
- Novartis Investigative Site
-
Hooksett, New Hampshire, United States, 03106
- Novartis Investigative Site
-
Laconia, New Hampshire, United States, 03246
- Novartis Investigative Site
-
Lebanon, New Hampshire, United States, 03756
- Novartis Investigative Site
-
-
New Jersey
-
Hackensack, New Jersey, United States, 07601
- Novartis Investigative Site
-
Livingston, New Jersey, United States, 07039
- Novartis Investigative Site
-
New Brunswick, New Jersey, United States, 08901
- Novartis Investigative Site
-
Princeton, New Jersey, United States, 24740
- Novartis Investigative Site
-
Somerville, New Jersey, United States, 08876
- Novartis Investigative Site
-
Sparta, New Jersey, United States, 07871
- Novartis Investigative Site
-
Vineland, New Jersey, United States, 08360
- Novartis Investigative Site
-
-
New Mexico
-
Albuquerque, New Mexico, United States, 87106
- Novartis Investigative Site
-
Albuquerque, New Mexico, United States, 87110
- Novartis Investigative Site
-
Las Cruces, New Mexico, United States, 88011
- Novartis Investigative Site
-
-
New York
-
Bronx, New York, United States, 10461
- Novartis Investigative Site
-
Bronx, New York, United States, 10467-2490
- Novartis Investigative Site
-
Buffalo, New York, United States, 14263
- Novartis Investigative Site
-
Cooperstown, New York, United States, 13326
- Novartis Investigative Site
-
East Syracuse, New York, United States, 13057
- Novartis Investigative Site
-
Manhasset, New York, United States, 11030
- Novartis Investigative Site
-
New York, New York, United States, 10003
- Novartis Investigative Site
-
New York, New York, United States, 10011
- Novartis Investigative Site
-
New York, New York, United States, 10016
- Novartis Investigative Site
-
New York, New York, United States, 10032
- Novartis Investigative Site
-
Rochester, New York, United States, 14642
- Novartis Investigative Site
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27599
- Novartis Investigative Site
-
Hendersonville, North Carolina, United States, 28791
- Novartis Investigative Site
-
Kinston, North Carolina, United States, 28501
- Novartis Investigative Site
-
Raleigh, North Carolina, United States, 27607
- Novartis Investigative Site
-
Washington, North Carolina, United States, 27889
- Novartis Investigative Site
-
Winston-Salem, North Carolina, United States, 27157
- Novartis Investigative Site
-
-
North Dakota
-
Bismarck, North Dakota, United States, 58501
- Novartis Investigative Site
-
Fargo, North Dakota, United States, 58122
- Novartis Investigative Site
-
Minot, North Dakota, United States, 58701
- Novartis Investigative Site
-
-
Ohio
-
Bowling Green, Ohio, United States, 43402
- Novartis Investigative Site
-
Canton, Ohio, United States, 44710
- Novartis Investigative Site
-
Chillicothe, Ohio, United States, 54601
- Novartis Investigative Site
-
Cincinnati, Ohio, United States, 45242
- Novartis Investigative Site
-
Clyde, Ohio, United States, 43410
- Novartis Investigative Site
-
Columbus, Ohio, United States, 43210
- Novartis Investigative Site
-
Columbus, Ohio, United States, 43214
- Novartis Investigative Site
-
Columbus, Ohio, United States, 43215
- Novartis Investigative Site
-
Columbus, Ohio, United States, 43222
- Novartis Investigative Site
-
Dayton, Ohio, United States, 45415
- Novartis Investigative Site
-
Franklin, Ohio, United States, 45005-1066
- Novartis Investigative Site
-
Greenville, Ohio, United States, 45331
- Novartis Investigative Site
-
Kettering, Ohio, United States, 45429
- Novartis Investigative Site
-
Maumee, Ohio, United States, 43623
- Novartis Investigative Site
-
Sandusky, Ohio, United States, 44870
- Novartis Investigative Site
-
Sylvania, Ohio, United States, 43560
- Novartis Investigative Site
-
Toledo, Ohio, United States, 43623
- Novartis Investigative Site
-
-
Oklahoma
-
Oklahoma City, Oklahoma, United States, 73120
- Novartis Investigative Site
-
Tulsa, Oklahoma, United States, 74136
- Novartis Investigative Site
-
-
Oregon
-
Eugene, Oregon, United States, 97401
- Novartis Investigative Site
-
Portland, Oregon, United States, 97210
- Novartis Investigative Site
-
-
Pennsylvania
-
Abington, Pennsylvania, United States, 19001-3788
- Novartis Investigative Site
-
Bethlehem, Pennsylvania, United States, 18015
- Novartis Investigative Site
-
Hershey, Pennsylvania, United States, 17033
- Novartis Investigative Site
-
Kingston, Pennsylvania, United States, 18704
- Novartis Investigative Site
-
Nashville, Pennsylvania, United States, 37204
- Novartis Investigative Site
-
Philadelphia, Pennsylvania, United States, 19111
- Novartis Investigative Site
-
Pottstown, Pennsylvania, United States, 19464
- Novartis Investigative Site
-
Sayre, Pennsylvania, United States, 18840
- Novartis Investigative Site
-
West Reading, Pennsylvania, United States, 19611
- Novartis Investigative Site
-
-
South Carolina
-
Charleston, South Carolina, United States, 29406
- Novartis Investigative Site
-
Greenville, South Carolina, United States, 29605
- Novartis Investigative Site
-
-
South Dakota
-
Rapid City, South Dakota, United States, 57701
- Novartis Investigative Site
-
-
Tennessee
-
Chattanooga, Tennessee, United States, 37403
- Novartis Investigative Site
-
Chattanooga, Tennessee, United States, 37404
- Novartis Investigative Site
-
Jackson, Tennessee, United States, 38301
- Novartis Investigative Site
-
Knoxville, Tennessee, United States, 37920
- Novartis Investigative Site
-
Memphis, Tennessee, United States, 38120
- Novartis Investigative Site
-
Nashville, Tennessee, United States, 37203
- Novartis Investigative Site
-
Nashville, Tennessee, United States, 37208
- Novartis Investigative Site
-
Nashville, Tennessee, United States, 37232
- Novartis Investigative Site
-
-
Texas
-
Beaumont, Texas, United States, 77702-1449
- Novartis Investigative Site
-
Bedford, Texas, United States, 76022
- Novartis Investigative Site
-
Fort Sam Houston, Texas, United States, 78234
- Novartis Investigative Site
-
Fort Worth, Texas, United States, 76104
- Novartis Investigative Site
-
Houston, Texas, United States, 77030
- Novartis Investigative Site
-
Lackland Air Force Base, Texas, United States, 78236
- Novartis Investigative Site
-
Longview, Texas, United States, 75601
- Novartis Investigative Site
-
McAllen, Texas, United States, 78503-1298
- Novartis Investigative Site
-
Mesquite, Texas, United States, 75150
- Novartis Investigative Site
-
Midland, Texas, United States, 79701
- Novartis Investigative Site
-
San Antonio, Texas, United States, 78209
- Novartis Investigative Site
-
San Antonio, Texas, United States, 78229
- Novartis Investigative Site
-
Tyler, Texas, United States, 75702
- Novartis Investigative Site
-
-
Utah
-
Salt Lake City, Utah, United States, 84112
- Novartis Investigative Site
-
-
Virginia
-
Hampton, Virginia, United States, 23666
- Novartis Investigative Site
-
Richmond, Virginia, United States, 23230
- Novartis Investigative Site
-
Roanoke, Virginia, United States, 24014
- Novartis Investigative Site
-
-
Washington
-
Bellingham, Washington, United States, 98225
- Novartis Investigative Site
-
Seattle, Washington, United States, 98122
- Novartis Investigative Site
-
Seattle, Washington, United States, 98133
- Novartis Investigative Site
-
Spokane, Washington, United States, 99218
- Novartis Investigative Site
-
Tacoma, Washington, United States, 98405
- Novartis Investigative Site
-
-
West Virginia
-
Charleston, West Virginia, United States, 25304
- Novartis Investigative Site
-
Huntington, West Virginia, United States, 25701
- Novartis Investigative Site
-
-
Wisconsin
-
Appleton, Wisconsin, United States, 53715
- Novartis Investigative Site
-
Chippewa Falls, Wisconsin, United States, 54729
- Novartis Investigative Site
-
Eau Claire, Wisconsin, United States, 54702
- Novartis Investigative Site
-
Green Bay, Wisconsin, United States, 54301
- Novartis Investigative Site
-
La Crosse, Wisconsin, United States, 54601
- Novartis Investigative Site
-
Madison, Wisconsin, United States, 53717
- Novartis Investigative Site
-
Oshkosh, Wisconsin, United States, 54904
- Novartis Investigative Site
-
Sturgeon Bay, Wisconsin, United States, 54235
- Novartis Investigative Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Key Inclusion Criteria:
- Patients >= 18 years of age with histologically confirmed, non-metastatic, operable and over expression/amplification of HER2 (3+ by IHC and/or FISH positive) primary breast cancer, treated with definitive surgery, with baseline LVEF >= 50%, known hormone receptor status (ER/PgR or ER alone) and ECOG performance status =< 1, were included.
- For Designs 1 and 2: Patients must have had received at least four cycles of an approved anthracycline-based (neo-) adjuvant chemotherapy regimen or a protocol specified exception.
- Approved, signed written informed consent obtained prior to any study specific screening procedures.
Key Exclusion Criteria:
- History of any prior (ipsi- and/or contralateral) invasive breast carcinoma, past (less than 10 years) or current history of malignant neoplasms, any clinically staged T4 tumor, or bilateral tumors.
- Concurrent anti-cancer treatment, except hormonal therapy or radiotherapy for the present breast cancer;
- Patients with positive or suspicious internal mammary nodes identified by sentinel node technique, which had not been irradiated or would not be irradiated, or patients with supraclavicular lymph node involvement.
- Any prior anti-HER therapy, which includes agents that target other members of the HER family of receptors, e.g. gefitinib (Iressa)
- (Neo-) or adjuvant chemotherapy using peripheral stem cell or bone marrow stem cell support;
- Serious cardiac illness or medical conditions.
Any of the following abnormal laboratory tests immediately prior to randomization:
- Serum total bilirubin >1.5 x upper limit of normal (ULN). In the case of known Gilbert's syndrome, a higher serum total bilirubin (<2 x ULN) was allowed;
- Alanine amino transferase (ALT) or aspartate amino transferase (AST) >2.5 x ULN;
- Alkaline phosphatase (ALP) >2.5 x ULN;
- Serum creatinine >2.0 x ULN;
- Total white blood cell count (WBC) <2.5 x 10^9/L;
- Absolute neutrophil count <1.5 x 10^9/L;
- Platelets <100 x 10^9/L.
- Women of childbearing potential and male patients with partners of childbearing potential, who are unable or unwilling to use adequate contraceptive measures during study treatment, and pregnant or lactating women.
- Concomitant use of CYP3A4 inhibitors or inducers.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Lapatinib plus Trastuzumab
Design 1: Oral lapatinib 1000 mg daily concurrent with trastuzumab 8 mg/kg IV loading dose followed by 6mg/kg IV every 3 weeks (52 weeks total). Design 2: Trastuzumab (4mg/kg loading dose followed by 2mg/kg IV weekly) concurrent with oral lapatinib 750 mg daily and either paclitaxel 80mg/m2 IV weekly for 12 weeks OR docetaxel 75mg/m2 every 21 days for 4 cycles (12 weeks). After completion of chemotherapy, the dose of lapatinib will be increased to 1000mg daily concurrently with trastuzumab every 3 weeks (6mg/kg without loading dose) for an additional 40 weeks (52 weeks total). Design 2B: Docetaxel 75mg/m2 and carboplatin AUC 6 every 3 weeks for 6 cycles (18 weeks) administered concurrently with oral lapatinib 750mg plus weekly trastuzumab (4mg/kg IV loading dose followed by 2mg/kg IV. After the completion of chemotherapy, trastuzumab will be administered every 3 weeks (6mg/kg without loading dose) concurrent with lapatinib 1000mg daily for an additional 40 weeks (52 weeks total). |
Antibody
Small molecule inhibitor
Other Names:
|
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Experimental: Trastuzumab followed by Lapatinib
Design 1: Trastuzumab (4mg/kg IV loading dose followed by 2mg/kg IV weekly) for 12 weeks followed by a 6 week treatment-free interval followed by oral lapatinib 1500mg daily for 34 weeks (52 weeks total). Design 2: Trastuzumab (4mg/kg IV loading dose followed by 2mg/kg IV weekly) for 12 weeks administered concomitantly and either paclitaxel 80mg/m2 IV weekly for 12 weeks OR docetaxel 75mg/m2 every 21 days for 4 cycles; followed by a 6 week treatment-free interval followed by oral lapatinib 1500mg daily for 34 weeks (52 weeks total). Design 2B: Docetaxel 75mg/m2 and carboplatin AUC 6 every 3 weeks for 6 cycles (18 weeks) administered concomitantly with trastuzumab (4mg/kg IV loading dose followed by 2mg/kg IV weekly) followed by a 6 week treatment-free interval followed by oral lapatinib 1500 mg daily for 28 weeks (52 weeks total). |
Antibody
Small molecule inhibitor
Other Names:
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Experimental: Lapatinib
Design 1: Lapatinib 1500mg oral daily for a total of 52 weeks. Design 2: Either paclitaxel 80mg/m2 IV weekly for 12 weeks OR docetaxel 75mg/m2 IV every 3 weeks for 4 cycles administered concomitantly with oral lapatinib at 750mg daily. After completion of chemotherapy, oral lapatinib administered at 1500mg daily for an additional 40 weeks (52 weeks total). Design 2B: Docetaxel 75mg/m2 and carboplatin AUC 6 every 3 weeks for 6 cycles (18 weeks) administered concomitantly with oral lapatinib at 750mg daily. After completion of chemotherapy, the dose of lapatinib will be increased to 1500mg oral daily for an additional 40 weeks (52 weeks total). |
Small molecule inhibitor
Other Names:
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Active Comparator: Trastuzumab
Design 1: Trastuzumab 8mg/kg IV loading dose followed by 6mg/kg IV every 3 weeks for a total of 52 weeks. Design 2: Either paclitaxel 80mg/m2 IV weekly for 12 weeks OR docetaxel 75mg/m2 IV every 3 weeks for 4 cycles administered concomitantly with trastuzumab 4mg/kg IV loading dose followed by 2mg/kg IV weekly. After completion of chemotherapy, trastuzumab administered every 3 weeks (6mg/kg IV without loading dose) for an additional 40 weeks (52 weeks total). Design 2B: Docetaxel 75mg/m2 and carboplatin AUC 6 every 3 weeks for 6 cycles (18 weeks) administered concomitantly with trastuzumab 4mg/kg IV loading dose followed by 2mg/kg IV weekly. After completion of chemotherapy, trastuzumab (6mg/kg without loading dose) every 3 weeks for an additional 40 weeks (52 weeks total). |
Antibody
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Disease-Free Survival (DFS) at the Primary Analysis
Time Frame: From randomization until the date of the first occurrence of disease recurrence, a contralateral invasive breast cancer, a second primary cancer, or death from any cause (median follow-up of 4.5 years)
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Disease-Free Survival (DFS) was defined as the interval between randomization and the date of first occurrence of disease recurrence (local, regional or distant), a contralateral invasive breast cancer, a second primary cancer or death without recurrence.
Only deaths occurring in participants whose clinical follow-up was ongoing at the time of death and who had no recurrence, contralateral breast cancer (CBC) or second primary malignancy (SPM) reported prior to death were considered as death without recurrence.
DFS was estimated using the Kaplan Meier method.
The percentile data values presented here indicate the percentage (95, 90, 85, 80 and 75 percent) of participants who had disease free survival for the indicated years.
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From randomization until the date of the first occurrence of disease recurrence, a contralateral invasive breast cancer, a second primary cancer, or death from any cause (median follow-up of 4.5 years)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Disease-Free Survival (DFS) at the 10-Year Follow-Up
Time Frame: From randomization until the date of the first occurrence of disease recurrence, a contralateral invasive breast cancer, a second primary cancer, or death from any cause, assessed up to approximately 10 years
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Disease-Free Survival (DFS) was defined as the interval between randomization and the date of first occurrence of disease recurrence (local, regional or distant), a contralateral invasive breast cancer, a second primary cancer or death without recurrence.
Only deaths occurring in participants whose clinical follow-up was ongoing at the time of death and who had no recurrence, contralateral breast cancer (CBC) or second primary malignancy (SPM) reported prior to death were considered as death without recurrence.
DFS was estimated using the Kaplan Meier method.
The percentile data values presented here indicate the percentage (95, 90, 85 and 80 percent) of participants who had disease free survival for the indicated years.
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From randomization until the date of the first occurrence of disease recurrence, a contralateral invasive breast cancer, a second primary cancer, or death from any cause, assessed up to approximately 10 years
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Overall Survival (OS) at the Primary Analysis
Time Frame: From randomization until death due to any cause (median follow-up of 4.5 years)
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Overall Survival (OS) was defined as the time from randomization until death due to any cause.
Participants who had not died were censored at the last date they were known to be alive, or date of withdrawal of consent.
OS was calculated in years as (date of death minus the date of randomization +1) divided by 365.25.
The percentile data values presented here indicate the percentage (99, 98, 97, 96, 95 and 90 percent) of participants who survived for the indicated years.
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From randomization until death due to any cause (median follow-up of 4.5 years)
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Overall Survival (OS) at the 10-Year Follow-Up
Time Frame: From randomization until death due to any cause, assessed up to approximately 10 years
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Overall Survival (OS) was defined as the time from randomization until death due to any cause.
Participants who had not died were censored at the last date they were known to be alive, or date of withdrawal of consent.
OS was calculated in years as (date of death minus the date of randomization +1) divided by 365.25.
The percentile data values presented here indicate the percentage (99, 98, 95 and 90 percent) of participants who survived for the indicated years.
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From randomization until death due to any cause, assessed up to approximately 10 years
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Analysis of Time to Recurrence (TTR)
Time Frame: From randomization until the date of the first occurrence of a disease recurrence, assessed up to approximately 10 years
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Time to Recurrence (TTR) was defined as the the time from randomization to breast cancer recurrence, ignoring second primary cancers (including contralateral breast cancers and non-breast second malignancies) and counting deaths without recurrence as a competing risk.
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From randomization until the date of the first occurrence of a disease recurrence, assessed up to approximately 10 years
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Analysis of Time to Distant Recurrence (TTDR)
Time Frame: From randomization until the date of the first occurrence of distant recurrence, assessed up to approximately 10 years
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Time to Distant Recurrence (TTDR) was defined as the the time from randomization to first distant breast cancer recurrence, ignoring locoregional recurrences and second primary cancers, (including contralateral breast cancers and non-breast second malignancies ) and counting deaths without recurrence as a competing risk.
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From randomization until the date of the first occurrence of distant recurrence, assessed up to approximately 10 years
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Analysis of Time to Central Nervous System (CNS) Recurrence
Time Frame: From randomization until the first central nervous system recurrence, assessed up to approximately 10 years
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Time to Central Nervous System (CNS) recurrence was defined as the time from randomization to first CNS recurrence.
Both brain metastasis and meningitis carcinomatosa were considered.
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From randomization until the first central nervous system recurrence, assessed up to approximately 10 years
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Cumulative Incidence of Brain Metastases
Time Frame: From randomization until the date of the first occurrence of a disease recurrence, assessed up to approximately 10 years
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The cumulative incidence of brain metastases as the first site of breast cancer recurrence among treatment arms was assessed using a hierarchy of primary type and location of first DFS event in cases where more than one event was identified simultaneously.
Because diagnostic procedures for different types of recurrence could not be performed on exactly the same day, any diagnoses noted within a two month (60 day) period of the first reported event was considered as identified simultaneously for purposes of defining the type of the first event and the date of event was be regarded as the earliest of the relevant events.
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From randomization until the date of the first occurrence of a disease recurrence, assessed up to approximately 10 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Nader-Marta G, Debien V, Eiger D, Tsourti Z, Caparica R, Kassapian M, Napoleone S, Hultsch S, Korde L, Wang Y, Chumsri S, Pritchard KI, Untch M, Bellet-Ezquerra M, Dornelles Rosa D, Moreno-Aspitia A, Piccart M, Dafni U, de Azambuja E. Outcomes of patients with small and node-negative HER2-positive early breast cancer treated with adjuvant chemotherapy and anti-HER2 therapy-a sub-analysis of the ALTTO study. Br J Cancer. 2022 Nov;127(10):1799-1807. doi: 10.1038/s41416-022-01963-8. Epub 2022 Sep 1.
- Moreno-Aspitia A, Holmes EM, Jackisch C, de Azambuja E, Boyle F, Hillman DW, Korde L, Fumagalli D, Izquierdo MA, McCullough AE, Wolff AC, Pritchard KI, Untch M, Guillaume S, Ewer MS, Shao Z, Sim SH, Aziz Z, Demetriou G, Mehta AO, Andersson M, Toi M, Lang I, Xu B, Smith IE, Barrios CH, Baselga J, Gelber RD, Piccart-Gebhart M; ALTTO Steering Committee and Investigators. Updated results from the international phase III ALTTO trial (BIG 2-06/Alliance N063D). Eur J Cancer. 2021 May;148:287-296. doi: 10.1016/j.ejca.2021.01.053. Epub 2021 Mar 23.
- Sonnenblick A, Agbor-Tarh D, de Azambuja E, Hultsch S, Izquierdo M, Liu M, Pruneri G, Harbeck N, Piccart M, Moreno-Aspita A, Granit RZ, Rouas G, Fahoum I, Sotiriou C. STAT3 activation in HER2-positive breast cancers: Analysis of data from a large prospective trial. Int J Cancer. 2021 Mar 15;148(6):1529-1535. doi: 10.1002/ijc.33385. Epub 2020 Nov 23.
- Eiger D, Ponde NF, Agbor-Tarh D, Moreno-Aspitia A, Piccart M, Hilbers FS, Werner O, Chumsri S, Dueck A, Kroep JR, Gomez H, Lang I, Rodeheffer RJ, Ewer MS, Suter T, de Azambuja E. Long-term cardiac outcomes of patients with HER2-positive breast cancer treated in the adjuvant lapatinib and/or trastuzumab Treatment Optimization Trial. Br J Cancer. 2020 May;122(10):1453-1460. doi: 10.1038/s41416-020-0786-x. Epub 2020 Mar 16.
- Holmes EM, Bradbury I, Williams LS, Korde L, de Azambuja E, Fumagalli D, Moreno-Aspitia A, Baselga J, Piccart-Gebhart M, Dueck AC, Gelber RD; ALTTO Trial Study Team. Are we assuming too much with our statistical assumptions? Lessons learned from the ALTTO trial. Ann Oncol. 2019 Sep 1;30(9):1507-1513. doi: 10.1093/annonc/mdz195.
- McCullough AE, Dell'orto P, Reinholz MM, Gelber RD, Dueck AC, Russo L, Jenkins RB, Andrighetto S, Chen B, Jackisch C, Untch M, Perez EA, Piccart-Gebhart MJ, Viale G. Central pathology laboratory review of HER2 and ER in early breast cancer: an ALTTO trial [BIG 2-06/NCCTG N063D (Alliance)] ring study. Breast Cancer Res Treat. 2014 Feb;143(3):485-92. doi: 10.1007/s10549-013-2827-0. Epub 2014 Jan 7.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 16, 2007
Primary Completion (Actual)
December 6, 2013
Study Completion (Actual)
July 1, 2021
Study Registration Dates
First Submitted
June 20, 2007
First Submitted That Met QC Criteria
June 20, 2007
First Posted (Estimated)
June 22, 2007
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 4, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EGF106708
- CLAP016B2301 (Other Identifier: Novartis)
- 2006-000562-36 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.