Epirubicin Plus Paclitaxel Versus Cyclophosphamide, Epirubicin and 5-Fluorouracil as Adjuvant Treatment of Node Positive Breast Cancer Patients: A Controlled Randomized Phase III Study
N/A
70 Years
Female
Breast Cancer
Trial Information
Epirubicin Plus Paclitaxel Versus Cyclophosphamide, Epirubicin and 5-Fluorouracil as Adjuvant Treatment of Node Positive Breast Cancer Patients: A Controlled Randomized Phase III Study
OBJECTIVES: I. Compare overall survival and disease free survival after adjuvant
chemotherapy with epirubicin plus paclitaxel versus cyclophosphamide, epirubicin, and
fluorouracil in women with stage IIA, IIB, or III breast cancer. II. Compare quality of life
in these women with these treatment regimens.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two
treatment arms within 35 days of surgery. Arm I: Patients receive epirubicin IV followed by
paclitaxel IV over 3 hours on day 1. Treatment repeats every 21 days for 4 courses. Arm II:
Patients receive cyclophosphamide IV, epirubicin IV, and fluorouracil IV on day 1. Treatment
repeats every 21 days for 6 courses. Treatment continues in the absence of disease
progression or unacceptable toxicity. Patients who are postmenopausal, or premenopausal and
hormone receptor positive, receive tamoxifen orally once a day for 5 years starting on day
1. Patients receive radiotherapy to residual breast after 4 courses of chemotherapy. Quality
of life is assessed. Patients are followed every 3 months for 3 years, every 6 months for 2
years, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 1,000 patients will be accrued for this study over 5 years.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically confirmed stage IIA, IIB, or III breast cancer
treated with radical surgery (e.g., mastectomy, quadrantectomy, tumorectomy) and axillary
lymph node dissection Positive axillary lymph nodes No more than 9 metastatic lymph nodes
No distant metastases or local or locoregional disease No more than 5 weeks between
surgery and beginning of study Hormone receptor status: Not specified
PATIENT CHARACTERISTICS: Age: 70 and under Sex: Female Menopausal status: Not specified
Performance status: ECOG 0 Life expectancy: Not specified Hematopoietic: WBC at least
3,000/mm3 Absolute neutrophil count at least 2,000/mm3 Platelet count at least 100,000/mm3
Hepatic: Transaminases, alkaline phosphatase, and gamma glutamyltransferase no greater
than 1.5 times upper limit of normal Renal: Not specified Cardiovascular: No heart disease
that precludes use of anthracyclines (i.e., myocardial infarction, uncontrolled angina
pectoris, uncontrolled arrhythmias, or valve disease) Other: No concurrent pathology that
precludes use of antineoplastic drugs No mental retardation or psychiatric disease that
precludes study No other current or prior malignancy within the past 10 years except
squamous or basal cell skin cancer or carcinoma in situ of the cervix Not pregnant or
nursing Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy Endocrine therapy: No prior antineoplastic hormonal therapy Radiotherapy: No
postoperative radiotherapy except to residual breast Surgery: See Disease Characteristics
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Principal Investigator
Riccardo Rosso, MD
Investigator Role:
Study Chair
Investigator Affiliation:
National Institute for Cancer Research, Italy
Authority:
United States: Federal Government
Study ID:
CDR0000067266
NCT ID:
NCT00005581
Start Date:
June 2000
Completion Date:
Related Keywords:
- Breast Cancer
- stage II breast cancer
- stage IIIA breast cancer
- stage IIIB breast cancer
- Breast Neoplasms
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