Neoadjuvant Breast Cancer Chemotherapy Study Opening at CORT
A new drug combination and sequence for the pre-operative (neoadjuvant) treatment of localized breast cancer has begun 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 paclitaxel (Taxol) therapy (AC>T>surgery). Recently, improved response and survival in metastatic breast cancer has been demonstrated with the combination of gemcitabine (Gemzar) and paclitaxel (Taxol) (GT), when compared to paclitaxel therapy alone. Based upon this promising finding, the integration of Gemzar into both adjuvant and neoadjuvant treatment studies has begun. The NSABP (National Surgical Adjuvant Breast Project), an NCI-sponsored cooperative research group, has been testing the adjuvant post-operative treatment of AC>GT in comparison to standard AC>T. In this study, drugs are given in a “dose dense” fashion, every 2 weeks.
The International Oncology Network (ION) has initiated a study of pre-operative chemotherapy integrating gemcitabine and another new drug, Abraxane, into the treatment program. Abraxane is paclitaxel packaged in microscopic albumin protein particles (nab-paclitaxel). Studies of Abraxane in metastatic breast cancer have shown superior responses and disease control, compared to standard paclitaxel therapy. In addition, because Abraxane is water soluble, it does not contain the solubility agent Cremaphor, which is responsible for most allergic reactions that are seen with standard paclitaxel. Therefore, treatment with Abraxane is by short IV infusion (not requiring 3 hours, as with standard paclitaxel), and steroid premedication to prevent allergic reaction is not required. Abraxane is more efficacious when administered as a weekly IV infusion.
The ION neoadjuvant study will treat localized breast cancer patients with weekly Abraxane x 8 weeks, along with gemcitabine (Gemzar) every 2 weeks x 4 cycles, followed by AC therapy every 2 weeks x 4 cycles (nab-PG>AC>surgery). This study is unique in giving the non-anthracycline portion of therapy first. This will allow the most direct observation of the benefit of the Abraxane-Gemzar combination in the treated patients. All patients will have baseline clinical and radiographic assessments (breast MRI and sonography) of their tumors. After completion of nab-PG and then AC, these assessments are repeated. Assessment of the pathologic response to therapy will be made by examination of the surgical specimens obtained after after completion of all therapy. A detailed analysis of clinical, molecular, and pathologic variables that influence response and outcomes will be assessed in the study. Patients will be followed for long-term outcomes.
For more information about this study, contact a Research Coordinator at 972-566-5588, or visit our website at www.CORTPA.com. Dr. Barry Mirtsching or CORT is the author and National Principle Investigator for this study.
Tags: Abraxane, Adriamycin, Breast Cancer, Cyclophosphamide, Cytoxan, doxorubicin, gemcitabine, Gemzar, Neoadjuvant Chemotherapy, paclitaxel, Pre-operative Chemotherapy, Taxol
