A Randomized Phase III Trial Comparing FEC-Chemotherapy vs. EC-Doc-Chemotherapy in Patients With Primary Breast Cancer
18 Years
70 Years
Female
Breast Cancer
Trial Information
A Randomized Phase III Trial Comparing FEC-Chemotherapy vs. EC-Doc-Chemotherapy in Patients With Primary Breast Cancer
OBJECTIVES:
- Compare the time to progression of women with primary breast cancer treated with
fluorouracil, epirubicin, and cyclophosphamide vs docetaxel, epirubicin, and
cyclophosphamide.
- Compare the overall survival of patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
- Compare quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according to metastatic axillary lymph node involvement (4-9 vs 10 or more), hormone
receptor status (estrogen and/or progesterone) of the primary tumor (negative vs positive),
and timing of adjuvant radiotherapy (intermittently after completion of 50% of chemotherapy
vs after completion of all chemotherapy). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive fluorouracil IV over 10-15 minutes and epirubicin IV over 15
minutes on days 1 and 8 and oral cyclophosphamide on days 1-14. Treatment repeats every
4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive epirubicin IV over 15 minutes and cyclophosphamide IV over 1
hour on days 1, 21, 42, and 63 and docetaxel IV over 1 hour on days 84, 105, 126, and
147 in the absence of disease progression or unacceptable toxicity.
Within 21 days after the completion of chemotherapy, patients undergo adjuvant radiotherapy
5 days a week for 5.5 weeks. Alternatively, patients may undergo radiotherapy intermittently
after completion of 50% of chemotherapy.
Upon completion of chemotherapy, patients with positive hormone receptor status (estrogen
and/or progesterone) receive oral tamoxifen daily for 5 years. Additionally, patients with
positive hormone receptor status who are under age 40 receive goserelin subcutaneously every
4 weeks for 2 years.
Quality of life is assessed at baseline, prior to each course of chemotherapy, 4 weeks after
completion of chemotherapy, 6 weeks after completion of radiotherapy, and then at 6 months
after completion of chemotherapy.
Patients are followed every 3 months for 3 years, every 6 months for 3 years, and then
annually thereafter.
PROJECTED ACCRUAL: A total of 446 patients (223 per treatment arm) will be accrued for this
study within 3 years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of primary epithelial invasive carcinoma of the breast
- T1-4, N1-2, M0
- Must have 4 metastatic axillary lymph nodes
- Complete resection of the primary tumor within the past 5 weeks
- Free of invasive carcinoma with at least 10 lymph nodes removed
- No inflammatory breast cancer
- No distant metastases by chest x-ray, liver ultrasound, and whole body bone scan
- Hormone receptor status:
- Estrogen and/or progesterone receptor status known
PATIENT CHARACTERISTICS:
Age
- 18 to 70
Sex
- Female
Menopausal status
- Not specified
Performance status
- ECOG 0-1
Life expectancy
- At least 32 weeks
Hematopoietic
- WBC at least 3,000/mm3
- Platelet count at least 100,000
Hepatic
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- SGOT/SGPT no greater than 1.5 times ULN
- Alkaline phosphatase no greater than 1.5 times ULN
- Albumin no greater than 1.5 times ULN
Renal
- Creatinine no greater than 1.5 times ULN
Cardiovascular
- No cardiomyopathy with impaired ventricular function
- No New York Heart Association class III or IV heart disease
- No cardiac arrhythmias influencing LVEF and requiring medication
- No myocardial infarction within the past 6 months
- No angina pectoris within the past 6 months
- No uncontrolled arterial hypertension
Other
- No other primary malignancy except carcinoma in situ of the cervix or adequately
treated basal cell skin cancer
- No known hypersensitivity to docetaxel, epirubicin, fluorouracil, cyclophosphamide,
or other study medication
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior cytotoxic or other antineoplastic therapy
- No other concurrent cytotoxic or other antineoplastic therapy
Endocrine therapy
- Not specified
Radiotherapy
- No prior radiotherapy
Surgery
- See Disease Characteristics
Other
- At least 3 weeks since prior investigational agents
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Comparison of time to progression
Safety Issue:
No
Principal Investigator
Harald Sommer, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Ludwig-Maximilians - University of Munich
Authority:
United States: Federal Government
Study ID:
LMU-ADEBAR
NCT ID:
NCT00047099
Start Date:
August 2001
Completion Date:
March 2012
Related Keywords:
- Breast Cancer
- stage II breast cancer
- stage IIIA breast cancer
- stage IIIB breast cancer
- Breast Neoplasms
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