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

21 de abril de 2014 atualizado por: 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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

4740

Estágio

  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

30 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Fêmea

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: B
Medicamento: Tamoxifen
Tamoxifen 20 mg/day tablets administered p.o. for a period ranging from 2.5 to 3 years.
Experimental: UMA
Medicamento: Exemestane
Exemestane 25 mg/day tablets administered p.o. for a period ranging from 2.5 to 3 years.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Disease-Free Survival (DFS) at Month 36 Post-Randomization: Main Study
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Overall Survival (OS) at Month 36 Post-Randomization: Main Study
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)/(2*1000). 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
Prazo: 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
Prazo: 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
Prazo: Baseline up to 24 months post-treatment
Baseline up to 24 months post-treatment

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Pfizer

Colaboradores

International Collaborative Cancer Group

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de fevereiro de 1998

Conclusão Primária (Real)

1 de junho de 2003

Conclusão do estudo (Real)

1 de março de 2013

Datas de inscrição no estudo

Enviado pela primeira vez

31 de maio de 2002

Enviado pela primeira vez que atendeu aos critérios de CQ

31 de maio de 2002

Primeira postagem (Estimativa)

3 de junho de 2002

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

7 de maio de 2014

Última atualização enviada que atendeu aos critérios de controle de qualidade

21 de abril de 2014

Última verificação

1 de abril de 2014

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 96-OEXE-031
  • A5991012

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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