- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00054587
Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer
Randomized And Multicentric Opened Phase III Study Evaluating The Concomitant Administration Of Docetaxel 75MG/M2 and Epirubicine 75MG/M2 Versus FEC 100 In Non Metastatic With Positive Lymphatic Nodes Breast Cancer Subjects, And The Sequential Addition Of Herceptin In (HER2+++) And (HER2++ And FISH+) Subjects
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which regimen of chemotherapy plus radiation therapy with or without trastuzumab is more effective in treating breast cancer.
PURPOSE: Randomized phase III trial to compare two different chemotherapy regimens plus radiation therapy with or without trastuzumab in treating women who have breast cancer that has spread to lymph nodes in the axilla (under the arm).
연구 개요
상태
정황
상세 설명
OBJECTIVES:
- Compare the efficacy of adjuvant cyclophosphamide, epirubicin, and fluorouracil vs adjuvant docetaxel and epirubicin, in terms of 5-year survival without relapse, in women with nonmetastatic adenocarcinoma of the breast with lymph node invasion.
- Determine survival of patients treated with these regimens.
- Compare the tolerability of trastuzumab (Herceptin) in patients treated with these regimens.
- Determine the efficacy and tolerability of trastuzumab in patients with hormone receptor-positive tumors.
- Evaluate the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to participating center. Patients are treated in 2 parts.
Part I: Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive fluorouracil IV, or epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 3 weeks for 6 courses. Patients then undergo radiotherapy 5 days a week for 5 weeks.
- Arm II: Patients receive epirubicin IV over 10 minutes and docetaxel IV over 1 hour on day 1. Treatment repeats every 3 weeks for 6 courses. Patients then undergo radiotherapy as in arm I.
Patients with HER2/neu-positive tumors then proceed to part II. Patients with HER2/neu-negative tumors receive no further treatment.
Patients with hormone (estrogen or progesterone) receptor-positive tumors also receive oral tamoxifen daily beginning after chemotherapy is completed and continuing for 5 years.
Part II: Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive trastuzumab (Herceptin) IV over 30-90 minutes every 3 weeks for 1 year.
- Arm II: Patients are followed without treatment. Patients not receiving trastuzumab are followed at 4 months, 6 months, every 4 months for 1 year, and then every 6 months for 3 years. Patients receiving trastuzumab are followed at 4 months and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 2,600 patients will be accrued for this study within 3 years.
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
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Angers, 프랑스, 49036
- Centre Paul Papin
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Annecy, 프랑스, 74011 Cedex
- Centre Hospitalier d'Annecy
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Bordeaux, 프랑스, 33076
- Institut Bergonie
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Bourg En Bresse, 프랑스, 01012
- C.H. Bourg En Bresse
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Caen, 프랑스, 14076
- Centre Regional Francois Baclesse
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Clermont-Ferrand, 프랑스, 63011
- Centre Jean Perrin
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Creteil, 프랑스, 94010
- Hopital Intercommunal de Creteil
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Dijon, 프랑스, 21079
- Centre de Lutte Contre le Cancer Georges-Francois Leclerc
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Grenoble, 프랑스, 38100
- Institut Prive de Cancerologie
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Harfleur, 프랑스, 76700
- Clinique du Petit Colmouilins
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Lagny Sur Marne, 프랑스, 77405
- Centre Hospitalier de Lagny
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Le Chesnay, 프랑스, 78157
- Hôpital André Mignot
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Le Havre, 프랑스, 76600
- CMC Les Ormeaux
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Marseille, 프랑스, 13273
- Institut J. Paoli and I. Calmettes
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Metz, 프랑스, 57038
- Centre Hospitalier Regional Metz Thionville
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Montbeliard, 프랑스, 25209
- Centre Hospitalier General Andre Boulloche
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Montpellier, 프랑스, 34298
- Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
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Mulhouse, 프랑스, 68051
- Centre Hospitalier de Mulhouse
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Nantes-Saint Herblain, 프랑스, 44805
- Centre Regional Rene Gauducheau
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Paris, 프랑스, 75674
- Hôpital Avicenne
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Perpignan, 프랑스
- Clinique Saint - Pierre
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Poitiers, 프랑스, 86021
- CHU Poitiers
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Reims, 프랑스, 51056
- Institut Jean Godinot
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Rennes, 프랑스, 35042
- Centre Eugène Marquis
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Sainte Clotilde, 프랑스, 97492
- Clinique Sainte Clotilde
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Strasbourg, 프랑스, 67065
- Centre Paul Strauss
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Strasbourg, 프랑스, 67091
- Hopitaux Universitaire de Strasbourg
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Toulouse, 프랑스, 31052
- Institut Claudius Regaud
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Villejuif, 프랑스, F-94805
- Institut Gustave Roussy
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS:
Histologically confirmed nonmetastatic, unilateral adenocarcinoma of the breast
- Axillary lymph node invasion (N1, N2, or N3)
- No cutaneous invasion
- No T4a or greater disease
- No clinically or radiologically suspected metastases
- No clinically or radiologically suspected contralateral lesion
- No deeply adherent or inflammatory disease
- Complete surgical resection performed, including removal of at least 5 lymph nodes, and with no residual tumor, within the past 42 days
- No prior breast cancer
Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age
- 18 to 64
Sex
- Female
Menopausal status
- Not specified
Performance status
- WHO 0-1
Life expectancy
- Not specified
Hematopoietic
- WBC at least 2,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- ALT and AST no greater than 1.5 times upper limit of normal (ULN)
- Alkaline phosphatase no greater than 2.5 times ULN
- Bilirubin no greater than ULN
- Hepatitis B and hepatitis C negative
- No hepatic dysfunction
Renal
- Creatinine less than 1.3 mg/dL OR
- Creatinine clearance greater than 60 mL/min
Cardiovascular
- ECHO normal
- LVEF at least 50%
Pulmonary
- FEV normal
- No dyspnea at rest
- No supplemental oxygen dependence
Other
- Not pregnant
- Fertile patients must use effective contraception
- HIV negative
- No active infection
- No other prior malignancy except basal cell skin cancer or carcinoma in situ of the cervix
- No contraindication to anthracycline therapy
- No chronic medical or psychological condition
- No geographic or social reason that would preclude study therapy
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- At least 4 weeks since prior chemotherapy
- No other concurrent chemotherapy
- No contraindication to anthracycline therapy
Endocrine therapy
- No prior hormonal therapy
Radiotherapy
- No prior radiotherapy
Surgery
- See Disease Characteristics
Other
- At least 4 weeks since prior experimental therapy
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
활성 비교기: 6 FEC
Patients receive fluorouracil IV, or epirubicin IV, and cyclophosphamide IV on day 1.
Treatment repeats every 3 weeks for 6 courses.
Patients then undergo radiotherapy 5 days a week for 5 weeks.
|
8 mg/kg at month M6, followed by a maintenance dose of 6 mg/kg every 3 weeks for a 1 year (i.e.
18 injections in total)
다른 이름들:
500 mg/m², D1 and every 3 weeks
100 mg/m², D1 and every 3 weeks
다른 이름들:
500 mg/m², D1 and every 3 weeks
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실험적: 6 DE
Patients receive epirubicin IV over 10 minutes and docetaxel IV over 1 hour on day 1.
Treatment repeats every 3 weeks for 6 courses.
Patients then undergo radiotherapy as in arm I
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8 mg/kg at month M6, followed by a maintenance dose of 6 mg/kg every 3 weeks for a 1 year (i.e.
18 injections in total)
다른 이름들:
100 mg/m², D1 and every 3 weeks
다른 이름들:
on day D1 of each cycle : dose: 75 mg/m², route: i.v.
injection over 1 hour, every 3 weeks
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Progression Free Survival
기간: 5 years from randomization
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5 years from randomization
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2차 결과 측정
결과 측정 |
기간 |
---|---|
Herceptin safety
기간: 5 years from randomization
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5 years from randomization
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Overall survival
기간: 5 years from randomization
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5 years from randomization
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공동 작업자 및 조사자
스폰서
수사관
- 연구 의자: Marc Spielmann, MD, Gustave Roussy, Cancer Campus, Grand Paris
간행물 및 유용한 링크
일반 간행물
- O'Sullivan CC, Bradbury I, Campbell C, Spielmann M, Perez EA, Joensuu H, Costantino JP, Delaloge S, Rastogi P, Zardavas D, Ballman KV, Holmes E, de Azambuja E, Piccart-Gebhart M, Zujewski JA, Gelber RD. Efficacy of Adjuvant Trastuzumab for Patients With Human Epidermal Growth Factor Receptor 2-Positive Early Breast Cancer and Tumors </= 2 cm: A Meta-Analysis of the Randomized Trastuzumab Trials. J Clin Oncol. 2015 Aug 20;33(24):2600-8. doi: 10.1200/JCO.2015.60.8620. Epub 2015 Jun 22.
- Mancini J, Genre D, Dalenc F, Maylevin F, Martin AL, Viens P, Julian-Reynier C. Transparency in the presentation of trial results may not increase patients' trust in medical researchers. Clin Trials. 2012 Feb;9(1):90-3. doi: 10.1177/1740774511427063. Epub 2011 Nov 2.
- Roché H, Allouache D, Romieu G, et al.: Five-year analysis of the FNCLCC-PACS04 trial: FEC100 vs ED75 for the adjuvant treatment of node positive breast cancer. [Abstract] 32nd Annual San Antonio Breast Cancer Symposium, December 9-13, 2009, San Antonio, Texas. A-602, 2009.
- Spielmann M, Roche H, Delozier T, Canon JL, Romieu G, Bourgeois H, Extra JM, Serin D, Kerbrat P, Machiels JP, Lortholary A, Orfeuvre H, Campone M, Hardy-Bessard AC, Coudert B, Maerevoet M, Piot G, Kramar A, Martin AL, Penault-Llorca F. Trastuzumab for patients with axillary-node-positive breast cancer: results of the FNCLCC-PACS 04 trial. J Clin Oncol. 2009 Dec 20;27(36):6129-34. doi: 10.1200/JCO.2009.23.0946. Epub 2009 Nov 16.
- Spielmann M, Roché H, Humblet Y, et al.: 3-year follow-up of trastuzumab following adjuvant chemotherapy in node positive HER2-positive breast cancer patients: results of the PACS-04 trial. [Abstract] Breast Cancer Res Treat 106 (1): A-72, S19, 2007.
- Spielmann M, Roché H, Delozier T, et al.: Safety analysis from PACS 04--a phase III trial comparing 6 cycles of FEC100 with 6 cycles of ET75 for node-positive early breast cancer patients, followed by sequential trastuzumab in HER2+patients: preliminary results. [Abstract] J Clin Oncol 24 (Suppl 18): A-632, 2006.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- UC-0140/0005 - PACS 04
- FRE-FNCLCC-PACS-04/0005
- EU-20236
- PACS04 (기타 식별자: UNICANCER)
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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