BCIRG 005

Study: BCIRG 005 (GMA TAX301)

Title	A multicenter phase III randomized trial comparing docetaxel in combination with doxorubicin and cyclophosphamide (TAC) versus doxorubicin and cyclophosphamide followed by docetaxel (ACT) as adjuvant treatment of operable breast cancer HER2neu negative patients with positive axillary lymph nodes
Results   Study Chairs	BCIRG 005 presentation on Efficacy Results at SABCS 2008 by Dr Eiermann     John Crown, MD, Wolfgang Eiermann, MD, John Mackey, MD
Sponsor	Aventis Oncology
Rationale	The sequence of AC followed by a taxane is gaining acceptance as an important treatment in adjuvant breast cancer. Comparing this ACT regimen, which requires 8 cycles, to 6 cycles of TAC (already compared to the standard regimen FAC as adjuvant therapy in BCIRG 001) will answer an important general/theoretical question and an important question for patients. The theoretical question is whether it is better to use drugs in combination or sequence. This is important for patients because it would reduce the amount of time on therapy to give the drugs in combination. An important feature of this study is that 6 cycles of the combination are given, other studies of this nature are giving 4 cycles. This difference may be crucial to provide a fair assessment of the relative merit of combination and sequential approaches.
Design		TAC (75/50/500 mg/mē) q21 days x 6 cycles AC  T AC (60/600 mg/mē) q21 days x 4 cycles  T (100mg/mē) q21 days x 4 cycles
Posters & Slides		Click here to download design slide
Major eligibility criteria	Histologically proven breast cancer Definitive surgical treatment is mastectomy or BCT (must include axillary LN dissection) within 60 days of registration Stage T 1-3, N1, M0 One, of at least 6 resected nodes, positive for tumor Tumor must be NEGATIVE for HER2neu overexpression by FISH Age 18 - 70 years, KPS > 80% Normal bone marrow, liver, renal and cardiac function No prior systemic therapy or RT for breast cancer 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	3,301 patients The primary objective of this trial is to show that TAC differs from ACT in terms of disease free survival (DFS). The following assumptions are made: - The DFS at 5 years of node-positive patients receiving ACT is around 50% - it is of clinical interest to detect 5% improvement in 5-year DFS i.e. an increase from 50% to 55%) - the error rate for a false positive outcome (a) is set to 5%, using two-sided significance tests - the error rate for a false negative outcome (b) is set to 20% i.e. the power of the trial is set to 80% for the difference of clinical interest
Participating countries	Argentina, Australia, Belgium, Bosnia, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Cyprus, Czech Rep., Estonia, France, Germany, Greece, Hong-Kong, Hungary, Ireland, Israel, Korea, Lebanon, Mexico, Poland, Portugal, Romania, Russia, Saudi Arabia, Slovakia, Slovenia, South Africa, Switzerland, Taiwan, Uruguay, USA, Venezuela

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