A Randomised Trial Of Standard Anthracycline-Based Chemotherapy With Fluorouracil, Epirubicin And Cyclophosphamide (FEC) Or Epirubicin And CMF (Epi-CMF) Versus FEC Followed By Sequential Docetaxel As Adjuvant Treatment For Women With Early Breast Cancer
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Locations
- 138
Study Overview
Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them after surgery may kill any tumor cells remaining after surgery. It is not yet known which combination chemotherapy regimen is more effective in treating resected stage I or stage II breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of different combination chemotherapy regimens in treating women who have resected stage I or stage II breast cancer.
Detailed Description
OBJECTIVES:
- Compare the disease-free and overall survival of women with completely resected stage I or II breast cancer adjuvantly treated with fluorouracil, epirubicin, and cyclophosphamide (FEC) or epirubicin followed by cyclophosphamide, methotrexate, and fluorouracil (EPI-CMF) versus FEC followed by sequential docetaxel.
- Compare the acute toxicity of these regimens in these patients.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, estrogen receptor status (positive vs negative), and nodal status. Within 8 weeks after definitive surgery, patients are randomized to 1 of 2 treatment arms.
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Arm I: Patients are assigned to 1 of 2 standard adjuvant chemotherapy regimens.
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Regimen A: Patients receive fluorouracil, epirubicin, and cyclophosphamide (FEC) IV on day 1. Treatment repeats every 3 weeks for 8 courses.
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Regimen B: Patients receive epirubicin IV on day 1. Treatment repeats every 3 weeks for 4 courses. Patients then receive cyclophosphamide orally on days 1-14 or IV on days 1 and 8 and methotrexate IV and fluorouracil IV on days 1 and 8 (CMF). Treatment with CMF repeats every 4 weeks for 4 courses.
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Arm II: Patients receive 4 courses of adjuvant chemotherapy with FEC as in arm I, regimen A. Patients then receive sequential docetaxel IV over 1 hour once every 3 weeks for 4 courses.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed completely resected, invasive breast cancer for which adjuvant chemotherapy is indicated
- •No clinical or radiological evidence of locoregional or metastatic disease
- •No locally advanced tumors at diagnosis, indicated by any of the following:
- •Fixed tumors
- •Peau d'orange skin changes
- •Skin ulceration
- •Inflammatory changes (T4 or T3b, N2 disease)
- •No male breast cancer
- •No prior invasive breast cancer or bilateral breast cancer
- •Prior ductal carcinoma in situ or lobular carcinoma in situ is allowed
- •Must begin study chemotherapy within 8 weeks after definitive surgery
- •Hormone receptor status:
- •Estrogen receptor and progesterone receptor status known
- •PATIENT CHARACTERISTICS:
- •Menopausal status:
- •Not specified
- •Performance status:
- •Life expectancy:
- •At least 2 years
- •Hematopoietic:
- •WBC at least 3,000/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin at least 9 g/dL
- •Bilirubin normal
- •AST no greater than 1.5 times normal
- •Alkaline phosphatase no greater than 1.5 times normal
- •Creatinine no greater than 1.5 times normal
- •Cardiovascular:
- •No myocardial infarction within the past 6 months
- •No congestive heart failure
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No other invasive malignancy within the past 10 years except surgically cured nonmelanoma skin cancer or carcinoma in situ of the cervix
- •No other serious medical illness that would limit life expectancy
- •No psychiatric condition that would preclude informed consent
- •No active uncontrolled bacterial, viral, or fungal infection
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No prior biologic therapy
- •Chemotherapy:
- •See Disease Characteristics
- •No prior cytotoxic chemotherapy
- •Endocrine therapy:
- •No concurrent hormonal therapy (e.g., tamoxifen) during study chemotherapy
- •No concurrent hormone replacement therapy
- •Radiotherapy:
- •No prior radiotherapy
- •See Disease Characteristics
- •At least 4 weeks since any prior unlicensed drugs
- +1 more not shown
Exclusion Criteria
- Not provided