The NSABP (National Surgical Adjuvant Breast Project) B-40 Study of new drug combinations, sequence, and the addition of anti-angiogenic therapy (bevacizumab=Avastin) for the pre-operative (neoadjuvant) treatment of localized breast cancer continues at the Center for Oncology Research & Treatment (CORT) in Dallas, Texas. Pre-operative chemotherapy for localized breast cancer is an established approach to therapy. Reduction in tumor size may increase the proportion of breast cancer patients who are candidates for breast conservation surgery (lumpectomy). Pre-operative therapy also may give important insight into what drug therapy benefits the patient individually, an observation that is not possible when chemotherapy is given after surgical excision of the breast cancer.
An established sequence of pre-operative chemotherapy utilizes doxorubicin (Adriamycin, and anthracycline drug) and cyclophosphamide (Cytoxan) followed by docetaxel (Taxotere) therapy (AC>T>surgery). Recently, improved response and survival in metastatic breast cancer has been demonstrated with the combinations of gemcitabine (Gemzar) and a taxane drug (GT) or capecitabine (Xeloda) and a taxane drug (XT), when compared to taxane therapy alone. Avastin (a monoclonal antibody against vascular endothelial growth factor, anti-VEGF) has been shown to improve the progression-free survival in metastatic breast cancer when added to standard taxane therapy. Based upon these promising findings, the integration of Gemzar and Xeloda and Avastin into both adjuvant and neoadjuvant treatment studies has begun.
In NSABP B-40, a NCI-sponsored cooperative research group study, the neoadjuvant pre-operative treatment of GT>AC or XT>AC are compared to standard T>AC. In this study, drugs are given in a “dose dense” fashion, every 2 weeks. Patients in all three pre-operative chemotherapy treatment arms will randomly be assigned to the addition of Avastin or placebo in addition to the chemotherapy.
Pre-treatment biopsy specimens need to be collected on this study for analysis. Therefore, potentially eligible patients should seek consultation with a NSABP B-40 medical oncologist prior to their initial biospies, so enrollment to the study can be done before the biopsy is done. Patients who have tumors >2 cm are eligible. CORT study personnel will work with your surgeon quickly after consultation, consent, and enrollment, so that your biopsy can be done properly to ensure eligibilty for the study. Biopsies done prior to enrollment are not suitable and disqualify patients from participation.
For more information about this study, contact a Research Coordinator at 972-566-5588 (Dallas) or 972-981-4012 (Plano), or visit our website at www.CORTPA.com. Dr. Barry Mirtsching or CORT is the Principle Investigator for this study.
Tags: Adriamycin, Avastin, bevacizumab, Breast Cancer, capecitabine, Cyclophosphamide, Cytoxan, docetaxel, doxorubicin, gemcitabine, Gemzar, Neoadjuvant Chemotherapy, NSABP, NSABP B-40 Study, Pre-operative Chemotherapy, Taxotere, Xeloda
