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

21 апреля 2014 г. обновлено: 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.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Действительный)

4740

Фаза

  • Фаза 3

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

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

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

30 лет и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Женский

Описание

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

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Двойной

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Активный компаратор: Б
Лекарство: Tamoxifen
Tamoxifen 20 mg/day tablets administered p.o. for a period ranging from 2.5 to 3 years.
Экспериментальный: А
Лекарство: Exemestane
Exemestane 25 mg/day tablets administered p.o. for a period ranging from 2.5 to 3 years.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Disease-Free Survival (DFS) at Month 36 Post-Randomization: Main Study
Временное ограничение: 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

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Overall Survival (OS) at Month 36 Post-Randomization: Main Study
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: Baseline up to 24 months post-treatment
Baseline up to 24 months post-treatment

Соавторы и исследователи

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Спонсор

Pfizer

Соавторы

International Collaborative Cancer Group

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Полезные ссылки

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования

1 февраля 1998 г.

Первичное завершение (Действительный)

1 июня 2003 г.

Завершение исследования (Действительный)

1 марта 2013 г.

Даты регистрации исследования

Первый отправленный

31 мая 2002 г.

Впервые представлено, что соответствует критериям контроля качества

31 мая 2002 г.

Первый опубликованный (Оценивать)

3 июня 2002 г.

Обновления учебных записей

Последнее опубликованное обновление (Оценивать)

7 мая 2014 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

21 апреля 2014 г.

Последняя проверка

1 апреля 2014 г.

Дополнительная информация

Термины, связанные с этим исследованием

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • 96-OEXE-031
  • A5991012

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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