이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

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

2014년 4월 21일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

4740

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

30년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

여성

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: 비
의약품: Tamoxifen
Tamoxifen 20 mg/day tablets administered p.o. for a period ranging from 2.5 to 3 years.
실험적: ㅏ
의약품: Exemestane
Exemestane 25 mg/day tablets administered p.o. for a period ranging from 2.5 to 3 years.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Disease-Free Survival (DFS) at Month 36 Post-Randomization: Main Study
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Overall Survival (OS) at Month 36 Post-Randomization: Main Study
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: Baseline up to 24 months post-treatment
Baseline up to 24 months post-treatment

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여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Pfizer

협력자

International Collaborative Cancer Group

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

1998년 2월 1일

기본 완료 (실제)

2003년 6월 1일

연구 완료 (실제)

2013년 3월 1일

연구 등록 날짜

최초 제출

2002년 5월 31일

QC 기준을 충족하는 최초 제출

2002년 5월 31일

처음 게시됨 (추정)

2002년 6월 3일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2014년 5월 7일

QC 기준을 충족하는 마지막 업데이트 제출

2014년 4월 21일

마지막으로 확인됨

2014년 4월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 96-OEXE-031
  • A5991012

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