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

2014年4月21日 更新者：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.

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

4740

段階

  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

30年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

女性

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：ダブル

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ：B
薬：Tamoxifen
Tamoxifen 20 mg/day tablets administered p.o. for a period ranging from 2.5 to 3 years.
実験的：あ
薬：Exemestane
Exemestane 25 mg/day tablets administered p.o. for a period ranging from 2.5 to 3 years.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Disease-Free Survival (DFS) at Month 36 Post-Randomization: Main Study
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Overall Survival (OS) at Month 36 Post-Randomization: Main Study
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Baseline up to 24 months post-treatment
Baseline up to 24 months post-treatment

協力者と研究者

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スポンサー

Pfizer

協力者

International Collaborative Cancer Group

出版物と役立つリンク

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便利なリンク

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

1998年2月1日

一次修了 (実際)

2003年6月1日

研究の完了 (実際)

2013年3月1日

試験登録日

最初に提出

2002年5月31日

QC基準を満たした最初の提出物

2002年5月31日

最初の投稿 (見積もり)

2002年6月3日

学習記録の更新

投稿された最後の更新 (見積もり)

2014年5月7日

QC基準を満たした最後の更新が送信されました

2014年4月21日

最終確認日

2014年4月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • 96-OEXE-031
  • A5991012

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