A Study of Avastin (Bevacizumab) Plus Taxane-Based Therapy in Patients With Locally Recurrent or Metastatic Breast Cancer.

An Open-label Study to Evaluate the Safety and Effect on Disease Progression and Overall Survival of Avastin Plus Taxane-based Chemotherapy in Patients With Locally Recurrent or Metastatic Breast Cancer

This single arm study will assess the safety and efficacy of a regimen of Avastin plus a taxane, with or without additional chemotherapy, as first-line treatment in patients with locally recurrent or metastatic breast cancer. All patients will receive Avastin (10mg/kg iv every 2 weeks, or 15 mg/kg iv every 3 weeks) plus taxane-based chemotherapy. If taxanes are contraindicated, alternative chemotherapy (other than anthracyclines or pegylated liposomal doxorubicin) may be used. The anticipated time on study treatment is until disease progression, and the target sample size is 500+ individuals.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: bevacizumab [Avastin]; Drug: Taxane-based chemotherapy

• Study Type: Interventional
• Enrollment (Actual): 2296
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1406
  • Buenos Aires, Argentina, 1878
  • La Plata, Argentina, B1902CMK
  • Rosario, Argentina, S2002KDS
  • Tucuman, Argentina, T4000IAK
• Australia
  • Adelaide, Australia, 5000
  • Darlinghurst, Australia, 2010
  • East Melbourne, Australia, 3002
  • Frankston, Australia, 3199
  • Gosford, Australia, 2250
  • Lismore, Australia, 2480
  • Maroochydore, Australia, 4558
  • Milton, Australia, 4064
  • Perth, Australia, 6000
  • Richmond, Australia, 3121
  • St. Leonards, Australia, 2065
  • Sydney, Australia, 2031
  • Sydney, Australia, 2060
  • Wodonga, Australia, 3690
• Austria
  • Bludesch, Austria, 6712
  • Bregenz, Austria, 6900
  • Dornbirn, Austria, 6850
  • Graz, Austria, 8036
  • Hall in Tirol, Austria, 6060
  • Innsbruck, Austria, 6020
  • Klagenfurt, Austria, 9026
  • Krems, Austria, 3500
  • Kufstein, Austria, 6330
  • Leoben, Austria, 8700
  • Linz, Austria, 4010
  • Ried-innkreis, Austria, 4910
  • St Pölten, Austria, 3100
  • St Veit An Der Glan, Austria, 9300
  • Steyr, Austria, 4400
  • Villach, Austria, 9500
  • Wels, Austria, 4600
  • Wien, Austria, 1030
  • Wien, Austria, 1130
  • Wien, Austria, 1160
  • Wien, Austria, 1220
  • Wien, Austria, 1140
  • Wiener Neustadt, Austria, 2700
  • Zams, Austria, 6511
• Brazil
  • Belo Horizonte, Brazil, 30140-083
  • Belo Horizonte, Brazil, 30150-221
  • Belo Horizonte, Brazil, 30150-320
  • Campinas, Brazil, 13060-803
  • Campinas, Brazil, 13073-400
  • Curitiba, Brazil, 80530-010
  • Curitiba, Brazil, 80730-180
  • Fortaleza, Brazil, 60125-151
  • Fortaleza, Brazil, 60741-420
  • Goiania, Brazil, 74075-040
  • Ijui, Brazil, 98700-000
  • JAU, Brazil, 17210-080
  • Joao Pessoa, Brazil, 58040280
  • Niteroi, Brazil, 24220-007
  • Piracicaba, Brazil, 13419-155
  • Porto Alegre, Brazil
  • Porto Alegre, Brazil, 90020-090
  • Porto Alegre, Brazil, 90035-903
  • Porto Alegre, Brazil, 90110-270
  • Porto Alegre, Brazil, 91430-001
  • Recife, Brazil, 52012-220
  • Ribeirao Preto, Brazil, 14025-430
  • Rio de Janeiro, Brazil, 21941-590
  • Rio de Janeiro, Brazil, 22031072
  • Rio de Janeiro, Brazil, 22631-004
  • Salvador, Brazil, 41950-610
  • Santos, Brazil, 11075-350
  • Sao Paulo, Brazil, 01232-010
  • Sao Paulo, Brazil, 01308-000
  • Sao Paulo, Brazil, 01308-050
  • Sao Paulo, Brazil, 01332-000
  • Sao Paulo, Brazil, 01406100
  • Sao Paulo, Brazil, 01509-900
  • Sao Paulo, Brazil, 03102-002
  • Sao Paulo, Brazil, 05403-010
  • Sao Paulo, Brazil, 08270-070
  • Sorocaba, Brazil, 18035-300
  • Vitoria, Brazil, 29055-270
• Bulgaria
  • Plovdiv, Bulgaria, 4004
  • Sofia, Bulgaria, 1784
  • Sofia, Bulgaria, 1527
  • Varna, Bulgaria, 9010
  • Veliko Tarnovo, Bulgaria, 5000
• Canada
  • Quebec, Canada, G1S 4L8
  • British Columbia
    • Surrey, British Columbia, Canada, V3V 1Z2
  • Ontario
    • Barrie, Ontario, Canada, L4M 6MZ
    • Brampton, Ontario, Canada, L6R 3J7
    • East York, Ontario, Canada, M4C 3E7
    • Mississauga, Ontario, Canada, L5M 2N1
    • Newmarket, Ontario, Canada, L3Y 2P9
    • Sault Ste Marie, Ontario, Canada, P6A 2C4
    • Scarborough, Ontario, Canada, M1P 2V5
    • St. Catharines, Ontario, Canada, L2R 7C6
    • Toronto, Ontario, Canada, M5G 2M9
    • Toronto, Ontario, Canada, M4N 3M5
    • Toronto, Ontario, Canada, M5B 1W8
    • Toronto, Ontario, Canada, M2K 1E1
    • Toronto, Ontario, Canada, M9C 1A5
    • Windsor, Ontario, Canada, N8W 2X3
  • Quebec
    • Montreal, Quebec, Canada, H2W 1S6
  • Saskatchewan
    • Regina, Saskatchewan, Canada, S4T 7T1
• China
  • Beijing, China, 100021
  • Beijing, China, 100071
  • Chang Sha, China, 410006
  • Changchun, China, 130012
  • Chengdu, China, 610041
  • Chongqing, China, 400038
  • Guangzhou, China, 510060
  • Hang Zhou, China, 310022
  • He Fei, China, 230022
  • Nanjing, China, 210002
  • Shanghai, China, 200032
  • Shanghai, China, 200080
  • Suzhou, China, 215006
  • Tianjin, China, 300060
• Colombia
  • Cali, Colombia
  • Neiva, Colombia
  • Pereira, Colombia
• Czech Republic
  • Brno, Czech Republic, 656 53
  • Hradec Kralove, Czech Republic, 500 05
  • Ostrava, Czech Republic, 708 52
  • Praha, Czech Republic, 180 81
• Ecuador
  • Quito, Ecuador, EC170125
• Egypt
  • Alexandria, Egypt, 11737
• Estonia
  • Tallin, Estonia, 11619
  • Tartu, Estonia, 50406
• Finland
  • Haemeenlinna, Finland, 13530
  • Kotka, Finland, 48210
  • Kuopio, Finland, 70211
  • Pori, Finland, 28500
  • Tampere, Finland, 33520
  • Turku, Finland, 20520
  • Vaasa, Finland, 65130
• France
  • Ales, France, 30100
  • Angers, France, 49933
  • Avignon, France, 84918
  • Bayonne, France, 64100
  • Bayonne, France, 64109
  • Besancon, France, 25030
  • Bobigny, France, 93009
  • Bordeaux, France, 33000
  • Bordeaux, France, 33077
  • Boulogne Sur Mer, France, 62222
  • Boulogne-billancourt, France, 92100
  • Brest, France, 29609
  • Chalon Sur Saone, France, 71100
  • Chateauroux, France, 36019
  • Clermont-ferrand, France, 63023
  • Colmar, France, 68024
  • Creteil, France, 94010
  • DAX, France, 40107
  • Dijon, France, 21000
  • GAP, France, 05007
  • Grenoble, France, 38043
  • L'isle D'espagnac, France, 16340
  • La Chaussee St Victor, France, 41260
  • La Tronche, France, 38700
  • Le Chesnay, France, 78157
  • Le Coudray, France, 28630
  • Le Mans, France, 72000
  • Lille, France, 59000
  • Lyon, France, 69437
  • Mantes La Jolie, France, 78201
  • Marseille, France, 13285
  • Marseille, France, 13291
  • Metz, France, 57038
  • Metz, France, 57072
  • Mont-de-marsan, France, 40024
  • Montbeliard, France, 25209
  • Montfermeil, France, 93370
  • Montpellier, France, 34967
  • Mougins, France, 06250
  • Nancy, France, 54100
  • Nevers, France, 58000
  • Nimes, France, 30900
  • Niort, France, 79021
  • Paris, France, 75970
  • Paris, France, 75908
  • Paris, France, 75651
  • Paris, France, 75475
  • Paris, France, 75012
  • Paris, France, 75231
  • Perigueux, France, 24000
  • Perpignan, France, 66000
  • Pierre Benite, France, 69310
  • Pontoise, France, 95300
  • Reims, France, 51056
  • Rouen, France, 76038
  • Saint Brieuc, France, 22015
  • Saint Gregoire, France, 35768
  • Saint Jean, France, 31240
  • Saint Pierre, France, 97448
  • Saint-cloud, France, 92210
  • Saint-denis de La Reunion, France, 97400
  • St-priest-en-jarez, France, 42271
  • Strasbourg, France, 67091
  • Strasbourg, France, 67065
  • Toulon, France, 83056
  • Toulouse, France, 31052
  • Toulouse, France, 31078
  • Tours, France, 37044
  • Valenciennes, France, 59322
  • Vandoeuvre Les Nancy, France, 54511
  • Vannes, France, 56001
  • Villeneuve-sur-lot, France, 47307
• Germany
  • Augsburg, Germany, 86150
  • Bad Saarow, Germany, 15526
  • Berlin, Germany, 10117
  • Berlin, Germany, 13125
  • Berlin, Germany, 13589
  • Bielefeld, Germany, 33604
  • Bochum, Germany, 44787
  • Böblingen, Germany, 71032
  • Chemnitz, Germany, 09116
  • Cottbus, Germany, 03046
  • Deggendorf, Germany, 94469
  • Dresden, Germany, 01307
  • Duisburg, Germany, 47051
  • Düsseldorf, Germany, 40479
  • Erfurt, Germany, 99085
  • Essen, Germany, 45122
  • Frankfurt, Germany, 65929
  • Freiburg, Germany, 79106
  • Halle, Germany, 06120
  • Hamburg, Germany, 22081
  • Hamburg, Germany, 20249
  • Hannover, Germany, 30167
  • Hannover, Germany, 30559
  • Kassel, Germany, 34117
  • Kiel, Germany, 24105
  • Leipzig, Germany, 04129
  • Lübeck, Germany, 23562
  • Magdeburg, Germany, 39108
  • Magdeburg, Germany, 39130
  • Mainz, Germany, 55131
  • Mannheim, Germany, 68167
  • München, Germany, 80638
  • Regensburg, Germany, 93053
  • Rostock, Germany, 18059
  • Saarbruecken, Germany, 66113
  • Stralsund, Germany, 18435
  • Stuttgart, Germany, 70176
  • Stuttgart, Germany, 70199
  • Troisdorf, Germany, 53804
  • ULM, Germany, 89075
  • Unna, Germany, 59423
  • Wiesbaden, Germany, 65199
  • Wuerselen, Germany, 52146
  • Wuppertal, Germany, 42105
• Hong Kong
  • Hong Kong, Hong Kong
  • Hong Kong, Hong Kong, 852
• Hungary
  • Budapest, Hungary, 1122
  • Budapest, Hungary, 1082
  • Szeged, Hungary, 6720
• Israel
  • Beer Sheva, Israel, 8410101
  • Haifa, Israel, 34354
  • Holon, Israel, 58100
  • Jerusalem, Israel, 91120
  • Jerusalem, Israel, 91031
  • Kfar Saba, Israel, 44281
  • Nahariya, Israel, 22100
  • Petach Tikva, Israel, 49100
  • Ramat-gan, Israel, 52621
  • Rehovot, Israel, 76100
  • Safed, Israel, 13110
  • Tel Aviv, Israel, 6423906
  • Zerifin, Israel, 70300
• Italy
  • Ancona, Italy
  • Aviano, Italy, 33081
  • Brescia, Italy, 25123
  • Cagliari, Italy, 09100
  • Cagliari, Italy, 09121
  • Candiolo, Italy, 10060
  • Carpi, Italy, 41012
  • Castelfranco Veneto, Italy, 31033
  • Castrovillari, Italy, 87012
  • Catania, Italy, 95100
  • Chieti, Italy, 66100
  • Como, Italy, 22100
  • Cremona, Italy, 26100
  • Frattamaggiore, Italy, 80027
  • Genova, Italy, 16132
  • Lecce, Italy, 73100
  • Lido Di Camaiore, Italy, 55043
  • Lucca, Italy, 55100
  • Mantova, Italy, 46100
  • Messina, Italy, 98123
  • Milano, Italy, 20162
  • Milano, Italy, 20142
  • Montevarchi, Italy, 52025
  • Napoli, Italy, 80131
  • Novara, Italy, 28100
  • Palermo, Italy, 90127
  • Paola, Italy, 87027
  • Pavia, Italy, 27100
  • Piove Di Sacco, Italy, 35028
  • Pordenone, Italy, 33170
  • Pozzuoli, Italy, 80087
  • Prato, Italy, 59100
  • Ravenna, Italy, 48100
  • Rionero in Vulture, Italy, 85028
  • Roma, Italy, 00168
  • Roma, Italy, 00128
  • Roma, Italy, 00153
  • Roma, Italy, 00144
  • Roma, Italy, 00189
  • Salerno, Italy, 84131
  • San Giovanni Rotondo, Italy, 71013
  • Saronno, Italy, 21047
  • Sassari, Italy, 07100
  • Siena, Italy, 53100
  • Torino, Italy, 10126
  • Verona, Italy, 37126
  • Vicenza, Italy, 36100
• Latvia
  • Riga, Latvia, LV-1002
  • Riga, Latvia, LV 1079
• Lebanon
  • Beirut, Lebanon, 1107 2020
  • Beirut, Lebanon, 166378
• Lithuania
  • Kaunas, Lithuania, 50009
  • Klaipeda, Lithuania, 5808
  • Vilnius, Lithuania, 08660
• Mexico
  • Chihuahua, Mexico, 31000
  • Ciudad Juarez, Mexico, 32300
  • Guadalajara, Mexico, 45200
  • Leon, Mexico, 37000
  • Mexico City, Mexico, 14140
  • Mexico City, Mexico, 06700
  • Mexico City, Mexico, 07360
  • Mexico City, Mexico, 97000
  • Puebla, Mexico, 72240
  • Tijuana, Mexico, 22320
• Morocco
  • Rabat, Morocco, 10 000
  • Rabat, Morocco, 21000
• Netherlands
  • Ac Amsterdam, Netherlands, 1091
  • Blaricum, Netherlands, 1261 AN
  • Capelle Ad Yssel, Netherlands, 2906 ZC
  • Delftzijl, Netherlands, 9934 JD
  • Doetinchem, Netherlands, 7009 BL
  • Goes, Netherlands, 4462 RA
  • Hoofddorp, Netherlands, 2134 TM
  • Vlissingen, Netherlands, 4382 EE
  • Zoetermeer, Netherlands, 2275 NA
• Poland
  • Bydgoszcz, Poland, 85-796
  • Lublin, Poland, 20-090
  • Olsztyn, Poland, 10-226
  • Poznan, Poland, 61-866
  • Warszawa, Poland, 00-909
  • Warszawa, Poland, 02-781
• Portugal
  • Almada, Portugal, 2801-951
  • Aveiro, Portugal, 3814-501
  • Barreiro, Portugal, 2830-094
  • Beja, Portugal, 7801-849
  • Cascais, Portugal, 2750-349
  • Coimbra, Portugal, 3000-061
  • Lisboa, Portugal, 1150-199
  • Lisboa, Portugal, 1649-035
  • Lisboa, Portugal, 1998-018
  • Porto, Portugal, 4200-319
  • Porto, Portugal, 4099-001
  • Porto, Portugal, 4200-072
  • Santa Maria Da Feira, Portugal, 4520-211
  • Santarém, Portugal, 2005-177
  • Setubal, Portugal, 2910-446
  • Vila Nova de Gaia, Portugal, 4434-502
• Russian Federation
  • Balashikha, Russian Federation, 143900
  • Barnaul, Russian Federation, 656049
  • Ekaterinburg, Russian Federation, 620905
  • Engels, Russian Federation, 413115
  • Izhevsk, Russian Federation, 426009
  • Kazan, Russian Federation, 420029
  • Kazan, Russian Federation, 420111
  • Kursk, Russian Federation, 305035
  • Moscow, Russian Federation, 107005
  • Moscow, Russian Federation, 125284
  • Moscow, Russian Federation, 115478
  • Moscow, Russian Federation, 121356
  • Moscow, Russian Federation, 143423
  • Smolensk, Russian Federation, 214000
  • St Petersburg, Russian Federation, 197022
  • St Petersburg, Russian Federation, 197758
  • Stavropol, Russian Federation, 355047
  • Tumen, Russian Federation, 625047
  • Tver, Russian Federation, 170008
  • UFA, Russian Federation, 450054
  • Ulyanovsk, Russian Federation, ND
• Saudi Arabia
  • Jeddah, Saudi Arabia, 21499
  • Riyadh, Saudi Arabia, 11211
  • Riyadh, Saudi Arabia, 22490
• Slovakia
  • Banska Bystrica, Slovakia, 975 17
  • Bratislava, Slovakia, 812 50
  • Bratislava, Slovakia, 831 01
  • Kosice, Slovakia, 041 90
  • Poprad, Slovakia, 05801
  • Presov, Slovakia, 080 01
  • Zilina, Slovakia, 012 07
• Slovenia
  • Ljubljana, Slovenia, 1000
• Spain
  • Alcorcon, Spain, 28922
  • Barakaldo, Spain, 48903
  • Barcelona, Spain, 08029
  • Castellon, Spain, 12002
  • Gijon, Spain, 33394
  • Las Palmas de Gran Canaria, Spain, 35016
  • Logroño, Spain, 26001
  • Madrid, Spain, 28905
  • Madrid, Spain, 28041
  • Madrid, Spain, 28943
  • Manresa, Spain, 08243
  • Murcia, Spain, 30008
  • Navarra, Spain, 31008
  • Orense, Spain, 32005
  • Palma de Mallorca, Spain, 07014
  • Pontevedra, Spain, 36002
  • Sabadell, Barcelona, Spain, 08208
  • Sagunto, Spain, 46520
  • Salamanca, Spain, 37007
  • San Sebastian, Spain, 20012
  • San Sebastian, Spain, 20080
  • Santiago de Compostela, Spain, 15706
  • Terrassa, Spain, 08221
  • Terrassa, Spain, 08227
  • Valencia, Spain, 46026
  • Vigo, Spain, 36204
  • Zamora, Spain, 49021
• Sweden
  • Göteborg, Sweden, 41345
  • Jonkoping, Sweden, 55185
  • Kalmar, Sweden, 39185
  • Karlstad, Sweden, 65185
  • Malmoe, Sweden, 20502
  • Stockholm, Sweden, 11486
  • Sundsvall, Sweden, 85186
  • Vaxjo, Sweden, 35185
  • Västerås, Sweden, 72189
• Switzerland
  • Aarau, Switzerland, 5000
  • Baden, Switzerland, 5404
  • Biel, Switzerland, 2502
  • Genolier, Switzerland, 1272
  • Locarno, Switzerland, 6601
  • Lugano, Switzerland, 6900
• Turkey
  • Adana, Turkey, 01330
  • Ankara, Turkey, 06230
  • Gaziantep, Turkey, 27310
  • Istanbul, Turkey, 34300
  • Istanbul, Turkey, 34390
  • Shhiye, Ankara, Turkey, 06100
• United Kingdom
  • Colchester, United Kingdom, CO3 3NB
  • Coventry, United Kingdom, CV2 2DX
  • Dundee, United Kingdom, DD1 9SY
  • Glasgow, United Kingdom, G11 6NT
  • London, United Kingdom, W6 8RF
  • Peterborough, United Kingdom, PE 3 9GZ
  • Sutton, United Kingdom, SM2 5PT
  • Truro, United Kingdom, TR1 3LJ
  • Westcliffe-on-sea, United Kingdom, SS0 0RY
  • Worthing, United Kingdom, B11 2DH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients, >=18 years of age;
• HER-2 negative adenocarcinoma of the breast, with locally recurrent or metastatic disease; (HER-2 positive patients only if previously treated with Herceptin in the adjuvant setting;
• candidates for chemotherapy.

Exclusion Criteria:

• previous chemotherapy for metastatic or locally recurrent breast cancer;
• concomitant hormonal therapy for metastatic or locally recurrent disease;
• concomitant Herceptin therapy for treatment of metastatic or locally recurrent HER-2 positive disease;
• previous radiotherapy for treatment of metastatic disease;
• evidence of CNS metastases.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: bevacizumab [Avastin]; 10mg/kg iv on day 1 of each 3 week cycle, or 15mg/kg iv on day 1 of each 2 week cycle; Drug: Taxane-based chemotherapy; As prescribed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) Related to Bevacizumab, Death, and AEs of Special Interest (AESIs)	Adverse events (including laboratory abnormalities) were assessed by the investigator according to the National Cancer Institute - Common Toxicity Criteria (NCI-CTC) grading systems.	Day 1 of Cycles 1, 2, 3, 4, 5, and 6 up to 6 months after the last bevacizumab infusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Disease Progression	Disease progression was assessed by the investigator per standard clinical practice using Response Evaluation Criteria In Solid Tumors (RECIST) criteria.	Baseline, Day 1 of Cycle 4, final visit and every 3 months during follow-up until disease progression or death up to 45 months
Time to Progression (TTP)	TTP was defined as the time period from the start of first-line therapy to investigator-assessed disease progression. Tumor assessments were performed according to standard clinical practice using NCI criteria. Participants who had not progressed at the time of analysis (including those who died before progressive disease [PD]) or who were lost to follow-up were censored at the last bevacizumab administration date. Time to disease progression was determined by Kaplan-Meier estimates.	Baseline, Day 1 of Cycle 4, final visit and every 3 months during follow-up until disease progression or death up to 45 months
Percentage of Participants With Recorded Death		Baseline, Day 1 of Cycle 4, final visit and every 3 months during follow-up until disease progression or death up to 45 months
Overall Survival	Overall Survival was defined as the time from start of first-line therapy to death due to any cause. Participants for whom no death was captured in the clinical database were censored at the last date they were known to be alive. Median time to overall survival was calculated by Kaplan Meier estimates.	Baseline, Day 1 of Cycle 4, Final Visit and every 3 months during follow-up until death up to 45 months
Percentage of Participants by Best Overall Response to Treatment	Best overall response is defined as the best response shown throughout the study. Tumor assessment was performed by the investigator using standard clinical practice.	Baseline, Day 1 of Cycle 4, final visit and every 3 months during follow-up until disease progression or death up to 45 months

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Publications and helpful links

General Publications

• Llombart-Cussac A, Pivot X, Biganzoli L, Cortes-Funes H, Pritchard KI, Pierga JY, Smith I, Thomssen C, Srock S, Sampayo M, Cortes J. A prognostic factor index for overall survival in patients receiving first-line chemotherapy for HER2-negative advanced breast cancer: an analysis of the ATHENA trial. Breast. 2014 Oct;23(5):656-62. doi: 10.1016/j.breast.2014.06.017. Epub 2014 Jul 19.
• Xu BH, Jiang ZF, Shen ZZ, Guan ZZ, Chen ZD, Cheng Y, Zheng H, Jiang J, Wang XJ, Tong ZS, Qin SK, Luo Y, Yao M, Wang LW, He J. Safety and efficacy of first-line bevacizumab combined with taxane therapy in Chinese patients with HER2-negative locally recurrent or metastatic breast cancer: findings from the ATHENA study. Chin Med J (Engl). 2012 Mar;125(5):764-9.

Study record dates

Study Major Dates

• Study Start: September 1, 2006
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: March 16, 2007
• First Submitted That Met QC Criteria: March 16, 2007
• First Posted (Estimate): March 19, 2007

Study Record Updates

• Last Update Posted (Estimate): May 25, 2015
• Last Update Submitted That Met QC Criteria: May 21, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Bevacizumab; Taxane
• Other Study ID Numbers: MO19391

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No