Phase III Randomized Study Of Adjuvant Fluourouracil, Epirubicin And Cyclophosphamide, In Women With Stage I Breast Cancer
18 Years
65 Years
Female
Breast Cancer
Trial Information
Phase III Randomized Study Of Adjuvant Fluourouracil, Epirubicin And Cyclophosphamide, In Women With Stage I Breast Cancer
OBJECTIVES:
- Compare the efficacy of 4 vs 6 courses of adjuvant fluorouracil, epirubicin, and
cyclophosphamide, in terms of 5-year survival, in women with stage I breast cancer.
- Compare the toxicity of these regimens in these patients.
- Determine the correlation of length of survival with biological factors in patients
treated with these regimens.
- Determine biological factors significant for prognosis and prediction of survival of
patients treated with these regimens.
- Determine the overall survival of patients treated with these regimens.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1
of 2 treatment arms.
- Arm I: Patients receive fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day
1. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease
progression or unacceptable toxicity.
- Arm II: Patients receive the same regimen as in arm I for up to 4 courses. After
completion of chemotherapy, patients undergo radiotherapy 5 days a week for 6 weeks.
Patients who are estrogen or progesterone receptor positive also receive oral tamoxifen
daily for 5 years, beginning after completion of chemotherapy.
Patients are followed every 6 months for 5 years.
PROJECTED ACCRUAL: A total of 1,512 patients (756 per treatment arm) will be accrued for
this study within 3 years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed nonmetastatic, unilateral adenocarcinoma of the breast
- Stage I
- No clinically or radiologically suspicious metastases
- No positive sentinel lymph nodes by immunohistochemistry for tumors less than 2
cm
- No clinically proven positive axillary lymph nodes
- Tumor cells found on immunohistochemistry only allowed
- No clinically or radiologically contralateral suspicious lesions
- No deeply adherent disease
- No cutaneous invasion
- No inflammatory disease
- Complete surgical resection within the past 42 days
- At least 8 lymph nodes removed
- Tumor at least 1 cm with no residual disease
- Presenting with at least 1 of the following factors of a poor prognosis:
- Tumor greater than 2 cm
- Hormone receptor negative tumor
- Grade II or III
- 35 years old or under
- Hormone receptor status:
- Positive or negative
PATIENT CHARACTERISTICS:
Age
- 18 to 65
Sex
- Female
Menopausal status
- Not specified
Performance status
- WHO 0-1
Life expectancy
- Not specified
Hematopoietic
- WBC at least 2,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Bilirubin no greater than 1.25 times upper limit of normal (ULN)
- AST and ALT no greater than 1.25 times ULN
- Alkaline phosphatase no greater than 2.5 times ULN
- No chronic hepatitis B
- No active hepatitis C
Renal
- Creatinine no greater than 1.25 times ULN
Pulmonary
- FEV normal
Other
- Not pregnant or nursing
- HIV negative
- No prior breast cancer or other malignancy
- No familial, social, or geographical reason that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior chemotherapy
Endocrine therapy
- No prior anticancer hormone therapy
Radiotherapy
- No prior radiotherapy
Surgery
- See Disease Characteristics
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Efficacy, in terms of 5-year survival
Outcome Time Frame:
5 years from randomization
Safety Issue:
No
Principal Investigator
Pierre Kerbrat, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Centre Eugene Marquis
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
PACS05 UC-0140-0106
NCT ID:
NCT00055679
Start Date:
August 2002
Completion Date:
June 2013
Related Keywords:
- Breast Cancer
- stage I breast cancer
- Breast Neoplasms
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