Randomized And Multicentric Phase III Study Evaluating The Benefit By Using A Chemotherapy With FEC 100 And Docetaxel In Non Metastatic Breast Cancer Which Has Relapsed After A Conservative Surgery
18 Years
65 Years
Female
Breast Cancer
Trial Information
Randomized And Multicentric Phase III Study Evaluating The Benefit By Using A Chemotherapy With FEC 100 And Docetaxel In Non Metastatic Breast Cancer Which Has Relapsed After A Conservative Surgery
OBJECTIVES:
- Compare the efficacy of adjuvant cyclophosphamide, epirubicin, and fluorouracil vs
observation, in terms of disease-free 5-year survival, in women who have undergone
resection for relapsed nonmetastatic breast cancer after initial conservative surgery.
- Compare the overall survival of women treated with these regimens.
- Determine the tolerance of these women to the chemotherapy regimen.
- Correlate prognostic factors of survival with efficacy of the chemotherapy regimen in
these women.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
menopausal status and participating center. Patients are randomized to 1 of 2 treatment
arms. Study begins within 42 days after resection of recurrent disease.
- Arm I: Patients receive fluorouracil IV over 1 hour, epirubicin IV over 1 hour, and
cyclophosphamide IV over 1 hour on day 1. Treatment repeats every 3 weeks for 3 courses
in the absence of disease progression or unacceptable toxicity. Patients then receive
docetaxel IV over 1 hour on day 1. Treatment repeats every 3 weeks for 3 courses in the
absence of disease progression or unacceptable toxicity.
- Arm II: Patients are examined on days 1 and 63.
Patients who are hormone receptor positive also receive one of the following hormonal
therapy regimens, depending on menopausal status:
- Oral tamoxifen daily for 5 years
- Oral tamoxifen daily for 5 years and oral luteinizing hormone-releasing hormone (LHRH)
agonist therapy (e.g., goserelin) for 3 years
- Oral LHRH agonist therapy (e.g., goserelin) for 3 years
- Oral antiaromatase therapy (e.g., anastrozole) for 5 years Patients also undergo
radiotherapy and may also undergo second complete resection.
Patients are followed every 6 months for 5 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 370 patients (185 per treatment arm) will be accrued for this
study within 3 years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the breast
- No contralateral breast cancer
- Local tumor recurrence more than 6 months after conservative surgery
- Complete or conservative resection of the recurrent tumor NOTE: Initial complete
surgical resection not allowed
- No local inflammatory disease or disease that is not amenable to complete surgical
resection
- No positive axillary lymph nodes
- No distant metastases, including subclavicular lymph nodes
- Hormone receptor status:
- Hormone receptor status known
PATIENT CHARACTERISTICS:
Age
- 18 to 65
Sex
- Female
Menopausal status
- Menopausal status known
Performance status
- ECOG 0-1
Life expectancy
- Not specified
Hematopoietic
- Neutrophil count at least 2,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Bilirubin no greater than upper limit of normal (ULN)
- Transaminases no greater than 1.5 times ULN
- Alkaline phosphatase no greater than 2.5 times ULN
- No chronic hepatitis B
- No active hepatitis C
Renal
- Not specified
Cardiovascular
- Cardiac function normal by echocardiogram or isotopes
Other
- No contraindications to anthracyclines such as any of the following:
- Prior doxorubicin over 300 mg/m^2
- Prior epirubicin over 600 mg/m^2
- Prior mitoxantrone over 90 mg/m^2
- No other invasive malignancy
- No chronic somatic or psychiatric condition that would preclude study participation
- No familial, social, geographic, or psychological reason that would preclude study
participation
- Not pregnant
- Fertile patients must use effective contraception
- HIV negative
- CA 153 no greater than 2 times ULN
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- See Patient Characteristics-Other
- No prior neoadjuvant chemotherapy
Endocrine therapy
- No prior neoadjuvant hormonal therapy
Radiotherapy
- No prior neoadjuvant radiotherapy
Surgery
- See Disease Characteristics
- At least 41 days since prior surgery
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Principal Investigator
Gilles Romieu, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Centre Val d'Aurelle - Paul Lamarque
Authority:
United States: Federal Government
Study ID:
CDR0000269549
NCT ID:
NCT00053911
Start Date:
November 2002
Completion Date:
Related Keywords:
- Breast Cancer
- recurrent breast cancer
- stage I breast cancer
- stage II breast cancer
- stage IIIA breast cancer
- Breast Neoplasms
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