Invasive Breast Carcinoma Clinical Trial
Official title:
Triple-Negative First-Line Study: Neoadjuvant Trial of Nab-Paclitaxel and MPDL3280A, a PDL-1 Inhibitor in Patients With Triple Negative Breast Cancer
This phase II trial studies how well nab-paclitaxel and atezolizumab before surgery work in treating patients with triple negative breast cancer (breast cancer cells that do not have estrogen receptors, progesterone receptors, or large amounts of human epidermal growth factor receptor 2 protein). Drugs used in chemotherapy, such as nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving nab-paclitaxel and atezolizumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. This drug combination before surgery may be an effective treatment for triple negative breast cancer.
PRIMARY OBJECTIVE: I. To evaluate the rate of pathologic complete response (pCR)/residual cancer burden (RCB)-0 + residual cancer burden (RCB)-I responses in patients with triple negative breast cancer (TNBC), who were non-responders to initial anthracycline and cyclophosphamide chemotherapy, treated with atezolizumab in combination with nab-paclitaxel in the neoadjuvant setting. SECONDARY OBJECTIVES: I. To estimate progression free survival (PFS) distribution of triple negative breast cancer (TNBC) patients who were non-responders to initial anthracycline and cyclophosphamide chemotherapy, treated with atezolizumab in combination with nab-paclitaxel in the neoadjuvant setting. II. To determine the safety of atezolizumab in combination with nab-paclitaxel in the neoadjuvant setting. EXPLORATORY OBJECTIVE: I. To investigate the association between biomarkers in the peripheral blood and tumor tissue with efficacy for TNBC patients treated with atezolizumab in combination with nab-paclitaxel in the neoadjuvant setting. OUTLINE: NEOADJUVANT: Patients receive atezolizumab intravenously (IV) over 60 minutes on day 1 and nab-paclitaxel IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. SURGERY: Patients undergo definitive breast surgery within 6 weeks of the completion of treatment. ADJUVANT: Within 4 weeks after surgery, patients receive atezolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months for up to 3 years. ;
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