BCIRG 002

Study: BCIRG 002 (RP56976-321)

Title	A multicenter phase III randomized trial comparing docetaxel in combination with doxorubicin and cyclophosphamide (TAC) with TAC followed by high dose chemotherapy with mitoxantrone, cyclophosphamide and vinorelbine (HDCT) with autologous peripheral stem cell transplantation and G-CSF in adjuvant treatment of operable breast cancer with 4 or more positive axillary nodes.
Study Chairs	Chuck Vogel MD, Miguel Martin MD
Sponsor	Aventis Oncology
Rationale	The role of high dose chemotherapy has not been determined in the high risk adjuvant setting. This study has been recognized by a independent panel of experts as one that could determine the benefit of high dose consolidation following effective therapy.
Design		TAC (75/50/500 mg/m2) six 21 day cycles TAC (75/50/500 mg/m2) four 21 day cycles MCV (64/6000/85 mg/m2) with stem cell transplant
Major eligibility criteria	Histologically proven breast cancer Definitive surgery that includes axillary LN dissection must be performed within 60 days of registration Stage T 1-3, N1, M0 At least four positive nodes out of a minimum of 6 resected nodes Age < 65 years, KPS > 90% Normal bone marrow, liver, renal and cardiac function No prior systemic therapy or RT for breast cancer Complete staging work-up performed Informed consent
Endpoints	Primary: Disease Free Survival Secondary: Overall Survival, toxicity and quality of life, and to evaluate pathologic and molecular markers for predicting efficacy.
Number of Patients	137 patients
Status	Enrollment Closed

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