Combination Chemotherapy Compared With Observation After Surgery in Treating Women With Relapsed Nonmetastatic Breast Cancer
Breast Cancer

About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring recurrent breast cancer, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer
Eligibility 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
Sites / Locations
- Clinique Claude Bernard
- Centre Paul Papin
- Centre Hospitalier d'Annecy
- Institut Sainte Catherine
- Institut Bergonie
- C.H. Bourg En Bresse
- CHU Hopital A. Morvan
- Centre Hospitalier General
- Centre Regional Francois Baclesse
- Centre Jean Perrin
- Centre Hospitalier Compiegne
- Clinique du Petit Colmouilins
- Centre Oscar Lambret
- Institut J. Paoli and I. Calmettes
- Hopital Notre-Dame de Bon Secours
- C.H. General Andre Boulloche
- Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
- Centre Hospitalier de Mulhouse
- Centre Regional Rene Gauducheau
- Clinique Saint - Pierre
- Centre Eugene Marquis
- Clinique Armoricaine De Radiologie
- Polyclinique de L'Ormeau
- Institut Claudius Regaud
- Hopital J. Ducuing
- Institut Gustave Roussy