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Randomized Trial Of Exemestane Versus Continued Tamoxifen In Postmenopausal Women With Early Breast Cancer (IES)

21 aprile 2014 aggiornato da: Pfizer

Randomized Double-Blind Trial In Postmenopausal Women With Primary Breast Cancer Who Have Received Adjuvant Tamoxifen For 2-3 Years, Comparing Subsequent Adjuvant Exemestane Treatment With Further Tamoxifen

To compare the sequential administration of exemestane with administration of further tamoxifen until 5 years in postmenopausal women with operable breast cancer who have already received 2-3 years of adjuvant tamoxifen, in terms of disease-free survival (DFS), overall survival (OS), incidence of contralateral breast cancer and long-term tolerability.

Panoramica dello studio

Stato

Completato

Condizioni

Neoplasie mammarie

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

4740

Fase

Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

Argentina
- - Buenos Aires, Argentina, 1181
    - Pfizer Investigational Site
  - Cordoba, Argentina, X5000AA1
    - Pfizer Investigational Site
- Buenos Aires
  - Haedo, Buenos Aires, Argentina, 1706
    - Pfizer Investigational Site
  - San Isidro, Buenos Aires, Argentina, 1642
    - Pfizer Investigational Site
  - San Martin, Buenos Aires, Argentina, 1650
    - Pfizer Investigational Site
- Capital Federal
  - Buenos Aires, Capital Federal, Argentina, 1406
    - Pfizer Investigational Site
  - Buenos Aires, Capital Federal, Argentina
    - Pfizer Investigational Site
  - Buenos Aires, Capital Federal, Argentina, 1426
    - Pfizer Investigational Site
  - Buenos Aires, Capital Federal, Argentina, 1417
    - Pfizer Investigational Site
  - Buenos Aires, Capital Federal, Argentina, 1425
    - Pfizer Investigational Site
- Pcia. de Santa Fe
  - Rosario 2000, Pcia. de Santa Fe, Argentina
    - Pfizer Investigational Site
- Santa Fe
  - Rosario, Santa Fe, Argentina, 2000
    - Pfizer Investigational Site
Australia
- New South Wales
  - Camperdown, New South Wales, Australia, 2050
    - Pfizer Investigational Site
  - Dubbo, New South Wales, Australia, 2830
    - Pfizer Investigational Site
  - Liverpool, New South Wales, Australia, 2170
    - Pfizer Investigational Site
  - Waratah, New South Wales, Australia, 2298
    - Pfizer Investigational Site
- South Australia
  - Adelaide, South Australia, Australia, 5000
    - Pfizer Investigational Site
- Victoria
  - Bendigo, Victoria, Australia, 3552
    - Pfizer Investigational Site
  - Box Hill, Victoria, Australia, 3128
    - Pfizer Investigational Site
  - Ringwood East, Victoria, Australia, 3135
    - Pfizer Investigational Site
Belgio
- - Antwerpen, Belgio, 2020
    - Pfizer Investigational Site
  - Arlon, Belgio, 6700
    - Pfizer Investigational Site
  - Baudour, Belgio, 7331
    - Pfizer Investigational Site
  - Brasschaat, Belgio, 2930
    - Pfizer Investigational Site
  - Bruxelles, Belgio, 1000
    - Pfizer Investigational Site
  - Bruxelles, Belgio, 1180
    - Pfizer Investigational Site
  - Charleroi, Belgio, 6000
    - Pfizer Investigational Site
  - Edegem, Belgio, 2650
    - Pfizer Investigational Site
  - Genk, Belgio, 3600
    - Pfizer Investigational Site
  - Haine St. Paul, Belgio, 7100
    - Pfizer Investigational Site
  - Hasselt, Belgio, 3500
    - Pfizer Investigational Site
  - Kraainem, Belgio, 1950
    - Pfizer Investigational Site
  - La Louviere, Belgio, 7100
    - Pfizer Investigational Site
  - Leuven, Belgio, 3000
    - Pfizer Investigational Site
  - Liege, Belgio, 4000
    - Pfizer Investigational Site
  - Merksem, Belgio, 2170
    - Pfizer Investigational Site
  - Namur, Belgio, 5000
    - Pfizer Investigational Site
  - Verviers, Belgio, 4800
    - Pfizer Investigational Site
  - Wilrijk, Belgio, 2610
    - Pfizer Investigational Site
Bosnia Erzegovina
- - Sarajevo, Bosnia Erzegovina, 71000
    - Pfizer Investigational Site
Bulgaria
- - Plovdiv, Bulgaria, 4004
    - Pfizer Investigational Site
  - Sofia, Bulgaria, 1756
    - Pfizer Investigational Site
  - Sofia, Bulgaria, 1504
    - Pfizer Investigational Site
  - Sofia, Bulgaria, 1784
    - Pfizer Investigational Site
  - Stara Zagora, Bulgaria, 6003
    - Pfizer Investigational Site
Croazia
- - Osijek, Croazia
    - Pfizer Investigational Site
  - Split, Croazia
    - Pfizer Investigational Site
  - Zagreb, Croazia, 10000
    - Pfizer Investigational Site
  - Zagreb, Croazia
    - Pfizer Investigational Site
Danimarca
- - Aarhus C, Danimarca, 8000
    - Pfizer Investigational Site
  - Esbjerg, Danimarca, 6700
    - Pfizer Investigational Site
  - Herlev, Danimarca, 2730
    - Pfizer Investigational Site
  - Herning, Danimarca, 7400
    - Pfizer Investigational Site
  - Hilleroed, Danimarca, 3400
    - Pfizer Investigational Site
  - Koebenhavn OE, Danimarca, 2100
    - Pfizer Investigational Site
  - Naestved, Danimarca, 4700
    - Pfizer Investigational Site
  - Roskilde, Danimarca, 4000
    - Pfizer Investigational Site
  - Vejle, Danimarca, 7100
    - Pfizer Investigational Site
  - Viborg, Danimarca, 8800
    - Pfizer Investigational Site
Egitto
- - Cairo, Egitto
    - Pfizer Investigational Site
Estonia
- - Tartu, Estonia, 51014
    - Pfizer Investigational Site
Federazione Russa
- - St. Petersburg, Federazione Russa, 197758
    - Pfizer Investigational Site
Francia
- - Angers, Francia, 49033 Cedex 01
    - Pfizer Investigational Site
  - Annecy Cedex, Francia, 74011
    - Pfizer Investigational Site
  - Avignon Cedex 2, Francia, 84082
    - Pfizer Investigational Site
  - Bordeaux, Francia, 33030 Cedex
    - Pfizer Investigational Site
  - Bordeaux, Francia, 33300 Cedex
    - Pfizer Investigational Site
  - Brest, Francia, 29609 Cedex
    - Pfizer Investigational Site
  - Caen, Francia, 14052 Cedex
    - Pfizer Investigational Site
  - Caen Cedex 05, Francia, 14076
    - Pfizer Investigational Site
  - Clermont Ferrand, Francia, 63011
    - Pfizer Investigational Site
  - Evreux, Francia, 27000
    - Pfizer Investigational Site
  - Lagny Sur Marne, Francia, 77405 Cedex
    - Pfizer Investigational Site
  - Le Havre, Francia, 76600
    - Pfizer Investigational Site
  - Le Mans, Francia, 72000
    - Pfizer Investigational Site
  - Lille, Francia, 59020 Cedex
    - Pfizer Investigational Site
  - Lyon, Francia, 69373
    - Pfizer Investigational Site
  - Marseille, Francia, 13273
    - Pfizer Investigational Site
  - Meaux, Francia, 77100
    - Pfizer Investigational Site
  - Montbeliard, Francia, 25209 Cedex
    - Pfizer Investigational Site
  - Mulhouse, Francia, 68070 Cedex
    - Pfizer Investigational Site
  - Nice, Francia, 06189
    - Pfizer Investigational Site
  - Paris, Francia, 75248 Cedex 5
    - Pfizer Investigational Site
  - Paris, Francia, 75970 Cedex 20
    - Pfizer Investigational Site
  - Perpignan, Francia, 66046
    - Pfizer Investigational Site
  - Rennes, Francia, 35042
    - Pfizer Investigational Site
  - Rouen, Francia, 76038 Cedex
    - Pfizer Investigational Site
  - Saint-Herblain, Francia, 44805
    - Pfizer Investigational Site
  - St Cloud, Francia, 92210
    - Pfizer Investigational Site
  - Strasbourg, Francia, 67091 Cedex
    - Pfizer Investigational Site
  - Toulouse, Francia, 31502
    - Pfizer Investigational Site
Germania
- - Berlin, Germania, 10117
    - Pfizer Investigational Site
  - Berlin, Germania, 13353
    - Pfizer Investigational Site
  - Chemnitz, Germania, 09126
    - Pfizer Investigational Site
  - Erlangen, Germania, 91054
    - Pfizer Investigational Site
  - Freiburg, Germania, 79106
    - Pfizer Investigational Site
  - Gera, Germania, 07548
    - Pfizer Investigational Site
  - Greiz, Germania, 07973
    - Pfizer Investigational Site
  - Halle, Germania, 06120
    - Pfizer Investigational Site
  - Halle, Germania, 06110
    - Pfizer Investigational Site
  - Hamburg, Germania, 22081
    - Pfizer Investigational Site
  - Hildburghausen, Germania, 98646
    - Pfizer Investigational Site
  - Leipzig, Germania, 04129
    - Pfizer Investigational Site
  - Luebeck, Germania, 23538
    - Pfizer Investigational Site
  - Muenchen, Germania, 80335
    - Pfizer Investigational Site
  - Riesa, Germania, 01589
    - Pfizer Investigational Site
  - Rodewisch, Germania, 08228
    - Pfizer Investigational Site
  - Saarbruecken, Germania, 66113
    - Pfizer Investigational Site
  - Suhl, Germania, 98527
    - Pfizer Investigational Site
  - Weiden, Germania, 92637
    - Pfizer Investigational Site
Grecia
- Attiki
  - Athens, Attiki, Grecia, 115 22
    - Pfizer Investigational Site
  - Athens, Attiki, Grecia, 115 28
    - Pfizer Investigational Site
- Crete
  - Heraklion, Crete, Grecia, 71 110
    - Pfizer Investigational Site
Hong Kong
- - New Territories, Hong Kong
    - Pfizer Investigational Site
Irlanda
- - Cork, Irlanda
    - Pfizer Investigational Site
  - Cork, Ireland, Irlanda
    - Pfizer Investigational Site
  - Dublin, Irlanda
    - Pfizer Investigational Site
  - Dublin 9, Irlanda
    - Pfizer Investigational Site
  - Galway, Irlanda
    - Pfizer Investigational Site
Israele
- - Haifa, Israele
    - Pfizer Investigational Site
  - Haifa, Israele, 34362
    - Pfizer Investigational Site
  - Jerusalem, Israele, 91120
    - Pfizer Investigational Site
  - Jerusalem, Israele
    - Pfizer Investigational Site
  - Kfar Saba, Israele
    - Pfizer Investigational Site
  - Petah Tikva, Israele
    - Pfizer Investigational Site
  - Rehovot, Israele
    - Pfizer Investigational Site
Italia
- - Alba (CN), Italia, 12051
    - Pfizer Investigational Site
  - Aviano (PN), Italia, 33081
    - Pfizer Investigational Site
  - Bergamo, Italia, 24128
    - Pfizer Investigational Site
  - Biella, Italia, 13900
    - Pfizer Investigational Site
  - Cagliari, Italia, 09121
    - Pfizer Investigational Site
  - Casale Monferrato, AL, Italia, 15033
    - Pfizer Investigational Site
  - Correggio, Italia, 42015
    - Pfizer Investigational Site
  - Cremona, Italia, 26100
    - Pfizer Investigational Site
  - Cuneo, Italia, 12100
    - Pfizer Investigational Site
  - Fermo FM, Italia, 63023
    - Pfizer Investigational Site
  - Firenze, Italia, 50134
    - Pfizer Investigational Site
  - Genova, Italia, 16132
    - Pfizer Investigational Site
  - Genova, Italia, 16128
    - Pfizer Investigational Site
  - Lecco, Italia, 23900
    - Pfizer Investigational Site
  - Lodi, Italia, 20075
    - Pfizer Investigational Site
  - Mantova, Italia, 46100
    - Pfizer Investigational Site
  - Milano, Italia, 20133
    - Pfizer Investigational Site
  - Milano, Italia, 20121
    - Pfizer Investigational Site
  - Milano, Italia, 20141
    - Pfizer Investigational Site
  - Milano, Italia, 21053
    - Pfizer Investigational Site
  - Modena, Italia, 41100
    - Pfizer Investigational Site
  - Monserrato (CA), Italia, 09042
    - Pfizer Investigational Site
  - Monza, Italia, 20052
    - Pfizer Investigational Site
  - Napoli, Italia, 80131
    - Pfizer Investigational Site
  - Palermo, Italia, 90139
    - Pfizer Investigational Site
  - Parma, Italia, 43100
    - Pfizer Investigational Site
  - Perugia, Italia, 06132
    - Pfizer Investigational Site
  - Piacenza, Italia, 29100
    - Pfizer Investigational Site
  - Pietra Ligure (SV), Italia, 17027
    - Pfizer Investigational Site
  - Pisa, Italia, 56100
    - Pfizer Investigational Site
  - Reggio Emilia, Italia, 42100
    - Pfizer Investigational Site
  - Roma, Italia, 00148
    - Pfizer Investigational Site
  - Sassari, Italia, 07100
    - Pfizer Investigational Site
  - Terni, Italia, 05100
    - Pfizer Investigational Site
  - Thiene (VI), Italia, 36016
    - Pfizer Investigational Site
  - Torino, Italia, 10126
    - Pfizer Investigational Site
  - Tortona, Italia, 15057
    - Pfizer Investigational Site
  - Trescore Balneario BG, Italia, 24069
    - Pfizer Investigational Site
  - Treviglio (BG), Italia, 24047
    - Pfizer Investigational Site
  - Varese, Italia, 21100
    - Pfizer Investigational Site
- Modena
  - Carpi, Modena, Italia, 41012
    - Pfizer Investigational Site
Lussemburgo
- - Luxembourg, Lussemburgo, 1210
    - Pfizer Investigational Site
Malta
- - Floriana, Malta, VLT 14
    - Pfizer Investigational Site
Norvegia
- - Bergen, Norvegia, 5021
    - Pfizer Investigational Site
  - Bodo, Norvegia, 8092
    - Pfizer Investigational Site
  - Fredrikstad, Norvegia, 1603
    - Pfizer Investigational Site
  - Haugesund, Norvegia, 5390
    - Pfizer Investigational Site
  - Levanger, Norvegia, 7600
    - Pfizer Investigational Site
  - Mo i Rana, Norvegia, 8607
    - Pfizer Investigational Site
  - Molde, Norvegia, 6407
    - Pfizer Investigational Site
  - Notodden, Norvegia, 3674
    - Pfizer Investigational Site
  - Oslo, Norvegia
    - Pfizer Investigational Site
  - Rissa, Norvegia, 7100
    - Pfizer Investigational Site
  - Rjukan, Norvegia, 3660
    - Pfizer Investigational Site
  - Sandefjord, Norvegia
    - Pfizer Investigational Site
  - Tonsberg, Norvegia, 3103
    - Pfizer Investigational Site
  - Tromso, Norvegia, 9038
    - Pfizer Investigational Site
  - Tromsø, Norvegia, 9038
    - Pfizer Investigational Site
Nuova Zelanda
- - Auckland, Nuova Zelanda, 1142
    - Pfizer Investigational Site
- Waikato
  - Hamilton, Waikato, Nuova Zelanda, 2021
    - Pfizer Investigational Site
Olanda
- - Amersfoort, Olanda, 3818 ES
    - Pfizer Investigational Site
  - Amsterdam, Olanda, 1105 AZ
    - Pfizer Investigational Site
  - Amsterdam, Olanda, 1066 CX
    - Pfizer Investigational Site
  - Amsterdam, Olanda, 1061 AE
    - Pfizer Investigational Site
  - Apeldoorn, Olanda, 7300 DS
    - Pfizer Investigational Site
  - Blaricum, Olanda, 1261 AN
    - Pfizer Investigational Site
  - Breda, Olanda, 4818 CK
    - Pfizer Investigational Site
  - Delft, Olanda, 2625 AD
    - Pfizer Investigational Site
  - Den Haag, Olanda, 2545 CH
    - Pfizer Investigational Site
  - Eindhoven, Olanda, 5623 EJ
    - Pfizer Investigational Site
  - Enschede, Olanda, 7513 ER
    - Pfizer Investigational Site
  - Groningen, Olanda, 9728 NZ
    - Pfizer Investigational Site
  - Groningen, Olanda, 9700 RM
    - Pfizer Investigational Site
  - Hengelo, Olanda, 7555 DL
    - Pfizer Investigational Site
  - Leeuwarden, Olanda, 8934 AD
    - Pfizer Investigational Site
  - Leiden, Olanda, 2333 ZA
    - Pfizer Investigational Site
  - Leidschendam, Olanda, 2262 BA
    - Pfizer Investigational Site
  - Podybus 90153, Olanda, 5200 ME Den Bosch
    - Pfizer Investigational Site
  - Roermond, Olanda, 6043 CV
    - Pfizer Investigational Site
  - Sittard, Olanda, 6131 BK
    - Pfizer Investigational Site
  - Utrecht, Olanda, 3582 KE
    - Pfizer Investigational Site
  - Veldhoven, Olanda, 5504 DB
    - Pfizer Investigational Site
  - Zaandam, Olanda, 1502 DV
    - Pfizer Investigational Site
Perù
- - Lima, Perù, L34
    - Pfizer Investigational Site
Polonia
- - Gdansk, Polonia, 80-952
    - Pfizer Investigational Site
  - Gliwice, Polonia, 44-101
    - Pfizer Investigational Site
  - Krakow, Polonia, 31-115
    - Pfizer Investigational Site
  - Krakow, Polonia, 31-826
    - Pfizer Investigational Site
  - Lodz, Polonia, 93-509
    - Pfizer Investigational Site
  - Opole, Polonia, 45-060
    - Pfizer Investigational Site
  - Poznan, Polonia, 61-878
    - Pfizer Investigational Site
  - Sopot, Polonia, 81-756
    - Pfizer Investigational Site
  - Warszawa, Polonia, 02-781
    - Pfizer Investigational Site
Portogallo
- - Coimbra, Portogallo, 3040
    - Pfizer Investigational Site
  - Coimbra, Portogallo
    - Pfizer Investigational Site
  - Evora, Portogallo, 7000-811
    - Pfizer Investigational Site
Regno Unito
- - Belfast, Regno Unito, BT97AB
    - Pfizer Investigational Site
  - Bradford, Regno Unito, BD9 6RJ
    - Pfizer Investigational Site
  - Bristol, Regno Unito, BS10 5NB
    - Pfizer Investigational Site
  - Cardiff, Regno Unito, CF14 2TL
    - Pfizer Investigational Site
  - Coventry, Regno Unito, CV2 2DX
    - Pfizer Investigational Site
  - East Kilbride, Regno Unito, G75 8RG
    - Pfizer Investigational Site
  - Huddersfield, Regno Unito, HD3 3EA
    - Pfizer Investigational Site
  - Leeds, Regno Unito, LS9 7TF
    - Pfizer Investigational Site
  - Leeds, Regno Unito, LS1 3EX
    - Pfizer Investigational Site
  - Lincoln, Regno Unito
    - Pfizer Investigational Site
  - London, Regno Unito, W6 8RF
    - Pfizer Investigational Site
  - London, Regno Unito, NW3 2QG
    - Pfizer Investigational Site
  - London, Regno Unito, N18 1QX
    - Pfizer Investigational Site
  - London, Regno Unito, SW17 0QT
    - Pfizer Investigational Site
  - London, Regno Unito, N19 5NF
    - Pfizer Investigational Site
  - Luton, Regno Unito, LU4 0DZ
    - Pfizer Investigational Site
  - Manchester, Regno Unito, M20 4BX
    - Pfizer Investigational Site
  - Sheffield, Regno Unito, S10 2SJ
    - Pfizer Investigational Site
  - Shrewsbury, Regno Unito
    - Pfizer Investigational Site
  - Somerset, Regno Unito, BA21 4AT
    - Pfizer Investigational Site
  - Southampton, Regno Unito, S016 6YD
    - Pfizer Investigational Site
  - Steeton, Regno Unito, BD20 6TD
    - Pfizer Investigational Site
  - Stoke on Trent, Regno Unito, ST4 6QG
    - Pfizer Investigational Site
  - Telford, Regno Unito, TF1 6TF
    - Pfizer Investigational Site
  - Wythenshawe, Manchester, Regno Unito, M23 9LT
    - Pfizer Investigational Site
- Cambs
  - Huntingdon, Cambs, Regno Unito, PE18 8NT
    - Pfizer Investigational Site
- Dorset
  - Bournemouth, Dorset, Regno Unito, BH7 7DW
    - Pfizer Investigational Site
- East Yorkshire
  - Hull, East Yorkshire, Regno Unito, HU16 5JQ
    - Pfizer Investigational Site
- Essex
  - Epping, Essex, Regno Unito, CM166TN
    - Pfizer Investigational Site
  - Westcliff-On-Sea, Essex, Regno Unito, SS0 0RY
    - Pfizer Investigational Site
- Gwent
  - Newport, Gwent, Regno Unito, NP6 2UB
    - Pfizer Investigational Site
- Gwynedd
  - Bangor, Gwynedd, Regno Unito, LL57 2PW
    - Pfizer Investigational Site
- Halifax
  - Salterhebble, Halifax, Regno Unito, HX6 0PW
    - Pfizer Investigational Site
- Hants
  - Gosport, Hants, Regno Unito, PO12 2AA
    - Pfizer Investigational Site
- Middlesex
  - Northwood, Middlesex, Regno Unito, HA6 2RN
    - Pfizer Investigational Site
- N. Ireland
  - Londonderry, N. Ireland, Regno Unito, BT47 1SB
    - Pfizer Investigational Site
- N. Yorkshire
  - Harrogate, N. Yorkshire, Regno Unito, HG2 7SX
    - Pfizer Investigational Site
- Somerset
  - Taunton, Somerset, Regno Unito, TA1 5DA
    - Pfizer Investigational Site
- South Wales
  - Swansea, South Wales, Regno Unito, SA2 8QA
    - Pfizer Investigational Site
- Yorkshire
  - York, Yorkshire, Regno Unito, Y03 7He
    - Pfizer Investigational Site
Repubblica Ceca
- - Brno, Repubblica Ceca, 656 53
    - Pfizer Investigational Site
  - Ceske Budejovice, Repubblica Ceca, 370 87
    - Pfizer Investigational Site
  - Prague 2, Repubblica Ceca, 12808
    - Pfizer Investigational Site
Romania
- - Bucuresti, Romania, 72435
    - Pfizer Investigational Site
  - Cluj Napoca, Romania, 400015
    - Pfizer Investigational Site
  - Timisoara, Romania, 300223
    - Pfizer Investigational Site
Serbia
- - Belgrade, Serbia, 11000
    - Pfizer Investigational Site
  - Sremska Kamenica, Serbia, 21204
    - Pfizer Investigational Site
Slovacchia
- - Banska Bystrica, Slovacchia, 97517
    - Pfizer Investigational Site
  - Bratislava, Slovacchia, SK-83310
    - Pfizer Investigational Site
  - Kosice, Slovacchia, 041 90
    - Pfizer Investigational Site
Slovenia
- - Ljubljana, Slovenia, 1000
    - Pfizer Investigational Site
Spagna
- - Albacete, Spagna, 02006
    - Pfizer Investigational Site
  - Alicante, Spagna, 03010
    - Pfizer Investigational Site
  - Badajoz, Spagna, 06008
    - Pfizer Investigational Site
  - Badajoz, Spagna, 06080
    - Pfizer Investigational Site
  - Cordoba, Spagna, 14004
    - Pfizer Investigational Site
  - Guadalajara, Spagna, 19002
    - Pfizer Investigational Site
  - Lleida, Spagna, 25198
    - Pfizer Investigational Site
  - Madrid, Spagna, 28034
    - Pfizer Investigational Site
  - Madrid, Spagna, 28041
    - Pfizer Investigational Site
  - Madrid, Spagna, 28040
    - Pfizer Investigational Site
  - Valencia, Spagna, 46014
    - Pfizer Investigational Site
  - Zaragoza, Spagna, 50009
    - Pfizer Investigational Site
- Alicante
  - Alcoy, Alicante, Spagna, 03804
    - Pfizer Investigational Site
  - Elche, Alicante, Spagna, 03203
    - Pfizer Investigational Site
  - San Juan de Alicante, Alicante, Spagna, 03550
    - Pfizer Investigational Site
  - Sant Joan D'Alacant, Alicante, Spagna, 03550
    - Pfizer Investigational Site
- Barcelona
  - Badalona, Barcelona, Spagna, 08916
    - Pfizer Investigational Site
  - Badalona, Barcelona, Spagna, 08911
    - Pfizer Investigational Site
  - Terrassa, Barcelona, Spagna, 08227
    - Pfizer Investigational Site
  - Terrassa, Barcelona, Spagna, 08221
    - Pfizer Investigational Site
- Guipuzcoa
  - San Sebastian, Guipuzcoa, Spagna, 20014
    - Pfizer Investigational Site
- Huesca
  - Barbastro, Huesca, Spagna, 22300
    - Pfizer Investigational Site
- Tarragona
  - Reus, Tarragona, Spagna, 43201
    - Pfizer Investigational Site
Stati Uniti
- Alabama
  - Birmingham, Alabama, Stati Uniti, 35205
    - Pfizer Investigational Site
  - Birmingham, Alabama, Stati Uniti, 35213
    - Pfizer Investigational Site
  - Birmingham, Alabama, Stati Uniti, 35235
    - Pfizer Investigational Site
- Arizona
  - Green Valley, Arizona, Stati Uniti, 85614
    - Pfizer Investigational Site
  - Green Velley, Arizona, Stati Uniti, 85614
    - Pfizer Investigational Site
  - Tucson, Arizona, Stati Uniti, 85715
    - Pfizer Investigational Site
  - Tucson, Arizona, Stati Uniti, 85712
    - Pfizer Investigational Site
  - Tucson, Arizona, Stati Uniti, 85710
    - Pfizer Investigational Site
  - Tucson, Arizona, Stati Uniti, 85704
    - Pfizer Investigational Site
  - Tucson, Arizona, Stati Uniti, 85745
    - Pfizer Investigational Site
- Colorado
  - Boulder, Colorado, Stati Uniti, 80304
    - Pfizer Investigational Site
  - Colorado Springs, Colorado, Stati Uniti, 80909
    - Pfizer Investigational Site
  - Denver, Colorado, Stati Uniti, 80218
    - Pfizer Investigational Site
  - Fort Collins, Colorado, Stati Uniti, 80528
    - Pfizer Investigational Site
  - Lakewood, Colorado, Stati Uniti, 80228
    - Pfizer Investigational Site
  - Thornton, Colorado, Stati Uniti, 80260
    - Pfizer Investigational Site
- Florida
  - Jacksonville, Florida, Stati Uniti, 32207
    - Pfizer Investigational Site
  - Jacksonville, Florida, Stati Uniti, 32204
    - Pfizer Investigational Site
  - Jacksonville Beach, Florida, Stati Uniti, 32250
    - Pfizer Investigational Site
  - Ocala, Florida, Stati Uniti, 34474
    - Pfizer Investigational Site
  - Orange Park, Florida, Stati Uniti, 32073
    - Pfizer Investigational Site
- Indiana
  - Fishers, Indiana, Stati Uniti, 46038
    - Pfizer Investigational Site
  - Fishers, Indiana, Stati Uniti, 46037
    - Pfizer Investigational Site
  - Indianapolis, Indiana, Stati Uniti, 46227
    - Pfizer Investigational Site
  - Indianapolis, Indiana, Stati Uniti, 46219
    - Pfizer Investigational Site
  - Indianapolis, Indiana, Stati Uniti, IN 46219
    - Pfizer Investigational Site
- Iowa
  - Cedar Rapids, Iowa, Stati Uniti, 52403
    - Pfizer Investigational Site
- Massachusetts
  - Pittsfield, Massachusetts, Stati Uniti, 01201
    - Pfizer Investigational Site
- New York
  - Albany, New York, Stati Uniti, 12206
    - Pfizer Investigational Site
  - Latham, New York, Stati Uniti, 12110-0610
    - Pfizer Investigational Site
- Oregon
  - Portland, Oregon, Stati Uniti, 97225
    - Pfizer Investigational Site
  - Portland, Oregon, Stati Uniti, 97227
    - Pfizer Investigational Site
- Texas
  - Arlington, Texas, Stati Uniti, 76014-2084
    - Pfizer Investigational Site
  - Bedford, Texas, Stati Uniti, 76022
    - Pfizer Investigational Site
  - Dallas, Texas, Stati Uniti, 75231
    - Pfizer Investigational Site
  - Dallas, Texas, Stati Uniti, 75230-2510
    - Pfizer Investigational Site
  - Dallas, Texas, Stati Uniti, 75246
    - Pfizer Investigational Site
  - El Paso, Texas, Stati Uniti, 79902
    - Pfizer Investigational Site
  - El Paso, Texas, Stati Uniti, 79915
    - Pfizer Investigational Site
  - Garland, Texas, Stati Uniti, 75042
    - Pfizer Investigational Site
  - Houston, Texas, Stati Uniti, 77030
    - Pfizer Investigational Site
  - Houston, Texas, Stati Uniti, 77024
    - Pfizer Investigational Site
  - Houston, Texas, Stati Uniti, 77074
    - Pfizer Investigational Site
  - Houston, Texas, Stati Uniti, 77029
    - Pfizer Investigational Site
  - Longview, Texas, Stati Uniti, 75601
    - Pfizer Investigational Site
  - McAllen, Texas, Stati Uniti, 78503
    - Pfizer Investigational Site
  - Mesquite, Texas, Stati Uniti, 75150
    - Pfizer Investigational Site
  - Odessa, Texas, Stati Uniti, 79761
    - Pfizer Investigational Site
  - Pasadena, Texas, Stati Uniti, 77502
    - Pfizer Investigational Site
  - Plano, Texas, Stati Uniti, 75075-7787
    - Pfizer Investigational Site
  - San Antonio, Texas, Stati Uniti, 78217
    - Pfizer Investigational Site
  - Sherman, Texas, Stati Uniti, 75090
    - Pfizer Investigational Site
  - Sugar Land, Texas, Stati Uniti, 77479
    - Pfizer Investigational Site
  - Tyler, Texas, Stati Uniti, 75702
    - Pfizer Investigational Site
  - Weslaco, Texas, Stati Uniti, 78596
    - Pfizer Investigational Site
- Washington
  - Spokane, Washington, Stati Uniti, 99202
    - Pfizer Investigational Site
  - Spokane, Washington, Stati Uniti, 99218
    - Pfizer Investigational Site
Sud Africa
- - Observatory, Sud Africa, 7925
    - Pfizer Investigational Site
- Gauteng
  - Johannesburg, Gauteng, Sud Africa, 2196
    - Pfizer Investigational Site
Svezia
- - Boras, Svezia, 501 82
    - Pfizer Investigational Site
  - Borås, Svezia, 50182
    - Pfizer Investigational Site
  - Goteborg, Svezia, 413 45
    - Pfizer Investigational Site
  - Halmstad, Svezia, 301 85
    - Pfizer Investigational Site
  - Helsingborg, Svezia, 251 87
    - Pfizer Investigational Site
  - Kristianstad, Svezia, 291 85
    - Pfizer Investigational Site
  - Linkoping, Svezia, 581 85
    - Pfizer Investigational Site
  - Lund, Svezia, 221 85
    - Pfizer Investigational Site
  - Malmo, Svezia, 205 02
    - Pfizer Investigational Site
  - Motala, Svezia, 591 85
    - Pfizer Investigational Site
  - Norrkoping, Svezia, 601 82
    - Pfizer Investigational Site
  - Nässjö, Svezia, 575 81
    - Pfizer Investigational Site
  - Varnamo, Svezia, 331 85
    - Pfizer Investigational Site
  - Vasteras, Svezia, 721 89
    - Pfizer Investigational Site
  - Vastervik, Svezia, 59381
    - Pfizer Investigational Site
  - Vaxjo, Svezia, 351 85
    - Pfizer Investigational Site
Svizzera
- - Basel, Svizzera, CH-4031
    - Pfizer Investigational Site
  - Bellinzona, Svizzera, CH-6500
    - Pfizer Investigational Site
  - Bern, Svizzera, 3010
    - Pfizer Investigational Site
  - Bern, Svizzera, CH-3012
    - Pfizer Investigational Site
  - Genève, Svizzera, CH-1211
    - Pfizer Investigational Site
Ungheria
- - Budapest, Ungheria, 1082
    - Pfizer Investigational Site
  - Budapest, Ungheria, 1122
    - Pfizer Investigational Site
  - Budapest, Ungheria, 1145
    - Pfizer Investigational Site

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

30 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sessi ammissibili allo studio

Femmina

Descrizione

Inclusion Criteria:

postmenopausal women with histologically or cytologically confirmed primary breast adenocarcinoma, receiving tamoxifen and have been treated with tamoxifen continuously for between 2 and 3 years and one month, and still free of disease

Exclusion Criteria:

unresectable breast cancer
ER negative primary tumor

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Scopo principale: Trattamento
Assegnazione: Randomizzato
Modello interventistico: Assegnazione parallela
Mascheramento: Doppio

Numero di armi

Armi e interventi

Gruppo di partecipanti / Arm	Intervento / Trattamento
Comparatore attivo: B	Droga: Tamoxifen Tamoxifen 20 mg/day tablets administered p.o. for a period ranging from 2.5 to 3 years.
Sperimentale: UN	Droga: Exemestane Exemestane 25 mg/day tablets administered p.o. for a period ranging from 2.5 to 3 years.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Disease-Free Survival (DFS) at Month 36 Post-Randomization: Main Study Lasso di tempo: Baseline up to Month 36	DFS defined as time from randomization to earliest documentation of breast cancer relapse or death from any cause. DFS at Month 36 post-randomization was defined as probability of participants alive and disease-free at 36 months after the randomization. Participants withdrawn from the study for any reason in the absence of relapse were censored at the date they were last seen. Relapse was categorized as follows: loco-regional: ipsilateral breast or axillary nodal relapse; distant: distant relapse, including supraclavicular nodes; second primary breast cancer: contralateral breast cancer, excluding ductal carcinoma in situ.	Baseline up to Month 36

Misure di risultato secondarie

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Pfizer

Collaboratori

International Collaborative Cancer Group

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

To obtain contact information for a study center near you, click here.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 febbraio 1998

Completamento primario (Effettivo)

1 giugno 2003

Completamento dello studio (Effettivo)

1 marzo 2013

Date di iscrizione allo studio

Primo inviato

31 maggio 2002

Primo inviato che soddisfa i criteri di controllo qualità

31 maggio 2002

Primo Inserito (Stima)

3 giugno 2002

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

7 maggio 2014

Ultimo aggiornamento inviato che soddisfa i criteri QC

21 aprile 2014

Ultimo verificato

1 aprile 2014

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

96-OEXE-031
A5991012

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Neoplasie mammarie

Tianjin Medical University Cancer Institute and...
Guangxi Medical University; Sun Yat-sen University; Chinese PLA General Hospital; The First Affiliated Hospital of Zhengzhou University e altri collaboratori

Completato

Le operazioni tecniche e il protocollo di applicazione clinica standard della CBBCT nel processo diagnostico del cancro al seno (CBBCT)

La guida all'applicazione clinica di Conebeam Breast CT

Cina
Emory University
National Cancer Institute (NCI)

Ritirato

Radiochirurgia stereotassica con Abemaciclib, Ribociclib o Palbociclib nel trattamento di pazienti con carcinoma mammario positivo ai recettori ormonali con metastasi cerebrali

Cancro al seno in stadio IV prognostico AJCC v8 | Neoplasia maligna metastatica nel cervello | Carcinoma mammario metastatico | Anatomic Stage IV Breast Cancer American Joint Committee on Cancer (AJCC) v8
NRG Oncology
National Cancer Institute (NCI)

Completato

Testare se il trattamento delle metastasi del cancro al seno con la chirurgia o le radiazioni ad alte dosi migliora la sopravvivenza

Cancro al seno in stadio anatomico IV AJCC v8 | Cancro al seno in stadio IV prognostico AJCC v8 | Neoplasia maligna metastatica nell'osso | Neoplasia maligna metastatica nei linfonodi | Neoplasia maligna metastatica nel fegato | Carcinoma mammario metastatico | Neoplasia maligna metastatica nel... e altre condizioni

Stati Uniti, Canada, Arabia Saudita, Corea del Sud
University of California, Davis
National Cancer Institute (NCI)

Sospeso

Gli effetti immunitari dell'integrazione nutrizionale di germe di grano fermentato nei pazienti con tumori solidi avanzati trattati con inibitori del checkpoint standard di cura

Cancro al seno in stadio anatomico III AJCC v8 | Neoplasia solida maligna avanzata | Cancro al polmone in stadio III AJCC v8 | Cancro al polmone in stadio IV AJCC v8 | Cancro a cellule renali in stadio III AJCC v8 | Cancro a cellule renali in stadio IV AJCC v8 | Melanoma cutaneo in stadio clinico... e altre condizioni

Stati Uniti

Prove cliniche su Tamoxifen

Ente Ospedaliero Ospedali Galliera
European Institute of Oncology; Fundacao Champalimaud

Completato

Follow-up a lungo termine dello studio TAM-01, uno studio di fase III di tamoxifene a bassa dose nel DCIS mammario e malattia premealigna (Babytam long)

Cancro al seno invasivo

Italia
Institut Cancerologie de l'Ouest

Attivo, non reclutante

Preservazione della fertilità mediante stimolazione ovarica associata a tamoxifene, precedente chemioterapia per il cancro al seno (PRESAGE)

Cancro al seno

Francia
The Methodist Hospital Research Institute
Millennium Pharmaceuticals, Inc.

Completato

TAK-228 Plus Tamoxifen in pazienti con carcinoma mammario ER-positivo, HER2-negativo (ANETT)

Cancro al seno positivo al recettore degli estrogeni

Stati Uniti
University Health Network, Toronto

Non ancora reclutamento

Studio Clinico per Osservare gli Effetti del Tamoxifene sul Recupero del Testosterone in Pazienti con Cancro alla Prostata Sottoposti a Castrazione Medica (REVIVE)

Cancro alla prostata | Ipogonadismo

Canada
Japanese Foundation for Cancer Research
Japan Clinical Oncology Group

Reclutamento

Studio randomizzato di fase III per la valutazione dell'efficacia di adiuvante Abemaciclib nei pazienti con recidiva locoregionale di carcinoma mammario HER2-negativo del recettore ormonale. JCOG2313, processo Aura. (AURA)

Cancro al seno | Terapia endocrina | Recidiva locoregionale | Abemaciclib

Giappone
Institut Claudius Regaud

Completato

miRNA circolanti come biomarcatori della sensibilità ormonale nel carcinoma mammario (MIRHO)

Cancro al seno

Francia
Eli Lilly and Company

Non ancora reclutamento

Uno studio su Imlunestrant (LY3484356) in donne in premenopausa con carcinoma mammario precoce positivo al recettore degli estrogeni (ER+) e negativo al recettore 2 del fattore di crescita epidermico umano (HER2-) (preEMBER)

Neoplasie mammarie

Stati Uniti, Belgio, Francia, Germania, Taiwan, Italia, Irlanda
Fudan University

Reclutamento

Inibitori di CDK4/6 combinati con terapia endocrina adiuvante standard in pazienti con carcinoma mammario HR+/HER2+ ad alto rischio

Cancro al seno | Terapia adiuvante

Cina
Institute of Cancer Research, United Kingdom

Attivo, non reclutante

Terapia endocrina preoperatoria per cure personalizzate con Abemaciclib (POETIC-A)

Femmina di cancro al seno

Regno Unito
The Netherlands Cancer Institute

Terminato

Trattamento endocrino di seconda linea seguito da capecitabina rispetto a capecitabina seguito da trattamento endocrino in pazienti con carcinoma mammario metastatico ER positivo

Cancro al seno

Olanda

Misura del risultato	Misura Descrizione	Lasso di tempo
Overall Survival (OS) at Month 36 Post-Randomization: Main Study Lasso di tempo: Baseline up to Month 120	OS was defined as the duration from randomization to death (due to any cause). OS at Month 36 post-randomization was defined as probability of participants' survival at 36 months after the randomization. For participants who were alive, OS was censored at the last available assessment. Probability of OS at Month 36 post-randomization was reported using Kaplan-Meier estimates at Month 36 post-randomization based on 120-month follow-up data.	Baseline up to Month 120
Number of Events of Second Breast Cancer in Contralateral Breast: Main Study Lasso di tempo: Baseline up to Month 120	Number of events of second primary breast cancer in contralateral breast (excluding ductal carcinoma in situ) were reported.	Baseline up to Month 120
Percent Change From Baseline in Lumbar Spine and Proximal Femur (Total Hip) Bone Mineral Density (BMD) at 6, 12, 24 Months On-treatment and 24 Months Post-treatment: Bone Metabolism Sub-study Lasso di tempo: Baseline, 6, 12, 24 months after randomization (on-treatment), 24 months post-treatment	BMD measurements for Lumbar spine (LS) and Proximal Femur (Total Hip [TH]) were performed using dual energy X-ray absorptiometry (DXA) for participants who entered the bone-metabolism sub-study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.	Baseline, 6, 12, 24 months after randomization (on-treatment), 24 months post-treatment
Percent Change From Baseline in Femoral Neck and Femoral Wards Bone Mineral Density (BMD) at 6, 12 and 24 Months On-treatment and 24 Months Post-treatment: Bone Metabolism Sub-study Lasso di tempo: Baseline, 6, 12, 24 months after randomization (on-treatment), 24 months post-treatment	BMD measurements for femoral neck (FN) and femoral wards (FW) were performed using dual energy X-ray absorptiometry (DXA) for participants who entered the bone-metabolism sub-study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.	Baseline, 6, 12, 24 months after randomization (on-treatment), 24 months post-treatment
Change From Baseline in Lumbar Spine and Proximal Femur (Total Hip) Bone Mineral Density (BMD) T-scores at 6, 12 and 24 Months On-treatment and 24 Months Post-treatment: Bone Metabolism Sub-study Lasso di tempo: Baseline, 6, 12, 24 months after randomization (on-treatment), 24 months post-treatment	BMD measurements for Lumbar spine (LS) and Proximal Femur (Total Hip [TH]) were performed using dual energy X-ray absorptiometry (DXA) for participants who entered the bone-metabolism sub-study. Results were scored as T-score. T-score indicated how many standard deviations higher or lower participant's value was when compared to the young normal reference mean. Using the World Health Organization (WHO) criteria for osteoporosis, a T-score of greater than or equal to (>=)-1.0 was classified as normal, a T-score of greater than -2.5 to less than -1.0 as osteopenic, and a T-score less than or equal to (<=)-2.5 as osteoporotic. Here 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.	Baseline, 6, 12, 24 months after randomization (on-treatment), 24 months post-treatment
Percentage of Bone Specific Alkaline Phosphatase (BAP) Serum Concentration Relative to Baseline: Bone Metabolism Sub-study Lasso di tempo: Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment	Bone specific alkaline phosphatase (BAP) serum concentration analyzed using enzyme immuno assay (EIA) at post-baseline time points was expressed as percentage of baseline BAP serum concentration. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.	Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment
Percentage of C-Terminal Telopeptide (CTX) Serum Concentration Relative to Baseline: Bone Metabolism Sub-study Lasso di tempo: Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment	C-terminal telopeptide (CTX) serum concentration analyzed using competitive enzyme-linked immunosorbent assay (ELISA) at post-baseline time points was expressed as percentage of baseline CTX serum concentration. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.	Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment
Percentage of Osteocalcin (OC) and Procollagen T1 C-Peptide (PICP) Serum Concentration Relative to Baseline: Bone Metabolism Sub-study Lasso di tempo: Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment	Osteocalcin (OC) serum concentration analyzed using ELISA and procollagen T1 c-peptide (PICP) serum concentration analyzed using sandwich EIA at post-baseline time points was expressed as percentage of baseline OC serum concentration and baseline PICP serum concentration, respectively. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points, for each group respectively.	Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment
Percentage of Deoxy-pyridinoline (DPD) Urine Concentration Relative to Baseline: Bone Metabolism Sub-study Lasso di tempo: Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment	Deoxy-pyridinoline (DPD) urine concentration (adjusted for urinary creatinine) analyzed using competitive EIA at post-baseline time points was expressed as percentage of baseline DPD urine concentration. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.	Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment
Percentage of N-telopeptide of Type 1 Collagen (NTX) Urine Concentration Relative to Baseline: Bone Metabolism Sub-study Lasso di tempo: Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment	N-telopeptide of Type 1 collagen (NTX) urine concentration (adjusted for urinary creatinine) analyzed using competitive inhibition EIA at post-baseline time points was expressed as percentage of baseline NTX urine concentration. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.	Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment
Number of Participants With Fracture: Bone Metabolism Sub-study Lasso di tempo: Baseline up to 24 months post-treatment		Baseline up to 24 months post-treatment
Change From Baseline in Treatment Outcome Index (TOI) at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study Lasso di tempo: Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization	The TOI was defined as the sum of 23 items based on following Functional Assessment of Cancer Therapy - Breast version [FACT-B] subscales: Physical well-being (7 items), Functional well-being (7 items), Breast cancer subscale (9 items). Each item was scaled from 0='Not at all' to 4='Very much'. Total TOI score ranged from 0 to 92, where higher TOI score indicated better health-related quality of life (QoL). A change of five points in the TOI scores was considered clinically meaningful. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation.	Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization
Change From Baseline in Functional Assessment of Cancer Therapy - Endocrine Subscale (FACT-ES) Total Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study Lasso di tempo: Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization	The FACT-ES assessed health-related QoL in participants with breast cancer. ES subscale comprised of 18 items (hot flushes,cold sweats,night sweats, vaginal discharge,vaginal irritation,vaginal bleeding,vaginal dryness,discomfort with intercourse,lost interest in sex,gained weight,light headed/dizzy,vomiting,had diarrhea,headaches,felt bloated,breast tenderness,mood swings, felt irritable).Participants indicated how true a statement was for them using a 5-point scale from 0 (not at all) to 4 (very much). For items that were negatively framed, the scores were reversed for the analysis so that higher scores equated to a good QoL. Total FACT-ES score was calculated as sum of all the 18 items and ranged from 0 to 72, where higher score indicated better QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.	Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization
Change From Baseline in Total Functional Assessment of Cancer Therapy - General Breast and Endocrine (FACT-GBE) Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study Lasso di tempo: Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization	FACT-GBE assessed health-related quality of life (QoL) in participants with breast cancer. It consisted of 56 items,summarized to 7 subscales(subscale 1 to 6 constituted total FACT-B and subscale 7 constituted total ES):physical well-being(7 items), social/family well-being(7 items),relationship with doctor (2 items),emotional well-being(6 items),functional well-being(7 items),breast cancer subscale(9 items),endocrine symptoms(18 items). Participants indicated how true a statement had been for them using 5-point scale from 0(not at all) to 4(very much). For items that were negatively framed,scores were reversed for analysis so that higher scores equated to good QoL. Total FACT-GBE score=sum of all 56 items(range 0 to 224, where higher score indicated better QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.	Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization
Change From Baseline in Physical Well-Being (PWB) Subscale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study Lasso di tempo: Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization	The PWB subscale assessed physical well-being related QoL in participants with breast cancer. PWB subscale comprised of 7 items (energy lack, nausea, family needs, pain, side effects, felt ill, forced to stay in bed). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). For items that were negatively framed, the scores were reversed for the analysis so that higher scores equated to a good QoL. Total PWB score was calculated as the sum of all the 7 items and ranged from 0 to 28, where higher score indicated better physical well-being related QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.	Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization
Change From Baseline in Social/Family Well-Being (SWB) Sub-scale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study Lasso di tempo: Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization	The SWB subscale assessed social/family well-being related QoL in participants with breast cancer. SWB subscale comprised of 7 items (distant from friends, emotional support, support from friends, family acceptance, family communication, close to main support, sexual satisfaction). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). For items that were negatively framed, the scores were reversed for the analysis so that higher scores equated to a good QoL. Total SWB score was calculated as the sum of all the 7 items and ranged from 0 to 28, where higher score indicated better social/family well-being related QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.	Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization
Change From Baseline in Relationship With Doctor (RWD) Subscale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Substudy Lasso di tempo: Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization	The RWD subscale assessed relationship with doctor in participants with breast cancer. RWD subscale comprised of 2 items (confidence in doctors, doctor answered questions). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). Total RWD score was calculated as the sum of the 2 items and ranged from 0 to 8, where higher score indicated better relationship with doctor. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.	Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization
Change From Baseline in Emotional Well-Being (EWB) Subscale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study Lasso di tempo: Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization	The EWB subscale assessed emotional well-being related QoL in participants with breast cancer. EWB subscale comprised of 6 items (felt sad, proud of coping, lost hope, felt nervous, worried about dying, worried about condition worsening). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). For items that were negatively framed, the scores were reversed for the analysis so that higher scores equate to a good QoL. Total EWB score was calculated as the sum of the 6 items and ranged from 0 to 24, where higher score indicated better emotional well-being related QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.	Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization
Change From Baseline in Functional Well-Being (FWB) Sub-scale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study Lasso di tempo: Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization	The FWB subscale assessed functional well-being related QoL in participants with breast cancer. FWB subscale comprised of 7 items (able to work, work fulfilled, able to enjoy life, acceptance of illness, sleeping well, enjoyed normal fun activities, contented with QoL). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). Total FWB score was calculated as the sum of the 7 items and ranged from 0 to 28, where higher score indicated better functional well-being related QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.	Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization
Change From Baseline in Breast Cancer Subscale (BCS) Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study Lasso di tempo: Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization	The BCS subscale assessed health related QoL in participants with breast cancer. BCS subscale comprised of 9 items (short of breath, self-conscious dress, tender/swollen arms, sexually attractive, bothered by hair loss, worried about familial risk, worried about family stress, bothered by weight change, able to feel like a woman). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). For items that were negatively framed, the scores were reversed for the analysis so that higher scores equated to a good QoL. Total BCS score was calculated as the sum of the 9 items and ranged from 0 to 36, where higher score indicated better QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.	Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization
Number of Participants With Severe Endocrine Symptoms: QoL Sub-study Lasso di tempo: Baseline up to 24 months after randomization	Participants indicated prevalence of an endocrine subscale items using a 5-point scale, where 0 (not at all), 1 (a little bit), 2 (somewhat), 3 (quite a bit), 4 (very much). Endocrine items were grouped in five categories vasomotor (hot flushes, cold sweats, night sweats, sleeping difficulties), neuropsychological (lack of energy, nervous feeling, lightheaded/dizzy, headaches, mood swings, feeling irritable), gastrointestinal symptoms (nausea, gained weight, vomiting, diarrhea, bloated feeling), gynecological symptoms (vaginal discharge, vaginal irritation, vaginal bleeding, vaginal dryness, discomfort with intercourse, lost interest in sex, breast tenderness) and other symptoms (pain, feeling ill, side effects). Number of participants who reported severe endocrine symptoms (defined as response categories "quite a bit" and "very much") were presented.	Baseline up to 24 months after randomization
Percentage of Participants With Endometrial Thickness Greater Than or Equal to (>=) 5 Millimeter (mm): Endometrial Sub-study Lasso di tempo: 6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment	Endometrial thickness was assessed using transvaginal ultrasound examination. 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.	6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment
Endometrial Thickness: Endometrial Sub-study Lasso di tempo: Baseline, 6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment	Endometrial thickness was assessed using transvaginal ultrasound examination. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.	Baseline, 6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment
Uterine and Overall Ovary Volume: Endometrial Sub-study Lasso di tempo: 6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment	Uterine volume (UV) and ovarian volume was estimated using ultrasonography. Uterine volume = (longitudinal diameter * transverse diameter * anteroposterior diameter of uterus)/(21000). Ovary volume = [(longitudinal diameter transverse diameter * anteroposterior diameter of ovary) * 3.14]/(6*1000). Overall ovary volume (OV) is calculated as the sum of the right and left ovary volume. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.	6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment
Number of Participants With Polyps, Fibroids and Ovarian Cysts: Endometrial Sub-study Lasso di tempo: 6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment	Number of participants with presence of polyps (POL) and fibroids (FIB) at post-baseline time points compared to the baseline (BL) status of 'yes', 'no' or 'missing' (that is, participants reporting POL/FIB at post-baseline time points who had yes, no or missing POL/FIB status at baseline, respectively) were presented. Result for number of participants with ovarian cysts was not analyzed at post-baseline time points as very few participants reported ovarian cysts at baseline.	6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment
Percentage of Participants With at Least 1 Gynecological Symptoms: Endometrial Sub-study Lasso di tempo: Baseline up to 24 months post-treatment	Gynecological symptoms included bleeding/spotting, pelvic pain, leucorrhoea and vaginal itching.	Baseline up to 24 months post-treatment
Number of Participants With Histological Findings: Endometrial Sub-study Lasso di tempo: Baseline up to 24 months post-treatment		Baseline up to 24 months post-treatment

Randomized Trial Of Exemestane Versus Continued Tamoxifen In Postmenopausal Women With Early Breast Cancer (IES)

Randomized Double-Blind Trial In Postmenopausal Women With Primary Breast Cancer Who Have Received Adjuvant Tamoxifen For 2-3 Years, Comparing Subsequent Adjuvant Exemestane Treatment With Further Tamoxifen

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