Cyclophosphamide, Methotrexate, and Fluorouracil, With or Without Epirubicin Hydrochloride, in Treating Women Who Have Undergone Surgery for Breast Cancer (Group III Closed to New Patients as of 12/7/2009)
Adjuvant Treatment of Biologically Aggressive Breast Cancer (N-,N+1,3): Controlled Clinical Study
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, methotrexate, fluorouracil, and epirubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving cyclophosphamide together with methotrexate and fluorouracil before, after, or without epirubicin hydrochloride is more effective in treating patients with breast cancer that can be removed by surgery.
PURPOSE: This randomized phase III trial is comparing three regimens of cyclophosphamide given together with methotrexate and fluorouracil, with or without epirubicin hydrochloride, to see how well it works in treating women who have undergone surgery for breast cancer. (Group III was closed to new patients as of 12/7/2009.)
연구 개요
상태
정황
상세 설명
OBJECTIVES:
Primary
- To determine the impact of adjuvant chemotherapy comprising epirubicin hydrochloride followed by cyclophosphamide, methotrexate, and fluorouracil versus cyclophosphamide, methotrexate, and fluorouracil followed by epirubicin hydrochloride versus cyclophosphamide, methotrexate, and fluorouracil on overall survival of patients with biologically aggressive, resectable, node-negative or node-positive breast cancer.
Secondary
- To assess the disease-free survival and patterns of relapse in these patients.
- To assess the tolerance to and toxicity of treatment in these patients.
- To determine the quality of life of these patients.
- To verify the effectiveness of these treatments in different subgroups of patients.
- To collect, retrospectively, information on the expression of tumor suppressor gene p53, oncogene c-erbB-2, and bcl-2 protein involved in apoptosis. (exploratory)
OUTLINE: This is a multicenter study. Patients are stratified according to center, lymph node status (N0 vs N1-3), and estrogen receptor status (negative vs positive). Patients are randomized to 1 of 3 treatment arms.
- Arm I: Beginning 4-6 weeks following surgery, patients receive epirubicin hydrochloride IV on day 1. Treatment repeats every 3 weeks for 4 courses. Patients then receive cyclophosphamide IV, methotrexate IV, and fluorouracil IV on days 1-8. Treatment repeats every 4 weeks for 4 courses.
- Arm II: Beginning 4-6 weeks following surgery, patients receive cyclophosphamide IV, methotrexate IV, and fluorouracil IV on days 1-8. Treatment repeats every 4 weeks for 4 courses. Patients then receive epirubicin hydrochloride IV on day 1. Treatment repeats every 3 weeks for 4 courses.
- Arm III (closed to accrual as of 12/7/2009): Beginning 4-6 weeks following surgery, patients receive cyclophosphamide IV, methotrexate IV, and fluorouracil IV on days 1-8. Treatment repeats every 4 weeks for 6 courses.
Patients with estrogen receptor-positive disease receive tamoxifen daily for 5 years after completing chemotherapy.
After completion of study therapy, patients are followed every 3 months for 1 year, every 6 months for 4 years, and then annually for 5 years.
연구 유형
등록 (예상)
단계
- 3단계
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS:
Histologically confirmed breast cancer
- Underwent radical mastectomy, guadrantectomy, or tumorectomy with axillary node dissection within the past 4-6 weeks
- Biologically aggressive disease
At least 10 lymph nodes removed
Node-negative (> 1 cm, or > 2 cm if histology is favorable, esp. tubular carcinoma and/or prevalent intraductal component > 50%) tumors OR node-positive (1-3) tumors, meeting the following criteria:
- High thymidine-labeling index (> 3%)
- Poorly differentiated tumor (grade III)
- High S-phase fraction (> 10% by flow cytometry)
- High Ki67/MIB1 expression (< 20%)
- No bilateral breast cancer
- No T4a, inoperable T4b, T4c, or T4d disease
- Any estrogen receptor status (positive, negative, unknown)
- No distant metastases
PATIENT CHARACTERISTICS:
- Any menopause status
- WBC ≥ 3,500/mL
- ANC ≥ 1,500/mL
- Platelet count ≥ 120,000/mL
- AST and ALT ≤ 1.5 times upper limit of normal (ULN)
- Creatinine ≤ 1.5 mg/mL
- Bilirubin ≤ 1.5 times ULN
- Not pregnant
- Geographically accessible for follow-up
- No prior breast cancer and/or other cancer except for carcinoma in situ of the cervix or basal cell skin cancer treated with radical intent
- No significant alterations in cardiovascular function
- No serious psychiatric disorders
- No impaired renal or liver function
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 마스킹: 없음(오픈 라벨)
연구는 무엇을 측정합니까?
주요 결과 측정
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전반적인 생존
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2차 결과 측정
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독성
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삶의 질
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무질병 생존
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Efficacy in subgroups of patients
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공동 작업자 및 조사자
수사관
- 수석 연구원: Dino Amadori, MD, Morgagni-Pierantoni Ospedale
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
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
- IRST-IBIS-03
- CDR0000661068 (레지스트리 식별자: PDQ (Physician Data Query))
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