A Randomized Phase II Study of Preoperative Cisplatin versus Paclitaxel in Patients with Triple Negative Breast Cancer without Germline BRCA Mutations: Evaluating the Homologous Recombination Deficiency (HRD) Biomarker
This research study is being done to learn more about the response of triple negative breast cancer’s (TNBC) response to neoadjuvant chemotherapy. Triple negative means that your breast cancer is negative for estrogen, progesterone, and HER2 receptors. In this research study, we are looking at preoperative chemotherapy with cisplatin or paclitaxel. Cisplatin and paclitaxel work by stopping or slowing cancer cells from growing.Cisplatin and paclitaxel are FDA approved for the treatment of breast cancer. However, their use as individual agents at the time before surgery is considered to be investigational. “Investigational” means that it is still being studied for use in this setting and that research doctors are trying to find out more about it and how effective it is for treating breast cancer.
Women who have triple negative breast cancer, are a candidate for preoperative chemotherapy, and do not have a BRCA1 or BRCA2 mutation are eligible to take part.
If you agree to participate in this study, you will sign a consent form and undergo baseline testing to make sure it is safe for you to join. You will have a physical exam, routine blood tests to check your blood and organ function, a pregnancy test if you are a woman able to become pregnant, and an imaging assessment of your tumor size by mammogram, ultrasound or MRI. If not already done, you may also have an assessment of the lymph nodes under your arm by fine needle aspiration (FNA) or biopsy. You will also have research blood samples and a tumor biopsy collected for the study.If you are eligible to continue, you will be randomized (like the flip of a coin) to receive either cisplatin or paclitaxel. Both you and your doctor will know the drug that you will receive. Both drugs are given by IV in the clinic. Cisplatin is given once every 3 weeks for a total of 4 doses. Paclitaxel is given once a week for 12 weeks for a total of 12 doses. About every 3 weeks you will have a physical exam and routine blood tests. Imaging to check the size of your tumor will be done at the end of treatment. We will collect blood for research again after about 3 weeks of treatment and tumor tissue at the time of your surgery (or by biopsy if you and your doctor make the decision to receive additional treatment before surgery).
11/26/2014 04:10 AM