The Clinical Core will provide expertise in the development, implementation and coordination of the clinical translational research trials performed in the Breast Cancer SPORE. The ultimate goal is to develop improved therapies for patients with or at risk of developing breast cancer through a better understanding of the biology of these cancers. To achieve this goal, the major responsibilities of the Clinical Core will be to 1) provide expertise in the development and implementation of translational clinical trials related to the SPORE projects;2) assure and maintain adequate accrual of patients that participate in SPORE-initiated clinical trials;3) provide research nurse, regulatory, data manager and specimen procurement support for these clinical trials;4) monitor and assure the safety of research subjects, adherence to institutional and federal regulatory requirements, and compliance with protocol-specified activities;and 5) oversee the timely and accurate entry of data into the OnCore and Breast SPORE databases. During the previous grant period, the Clinical Core provided support for 4 therapeutic clinical trials that accrued 140 patients overall. The Core's efforts were pivotal in coordinating data collection and transfer from collaborating institutions participating in some of these trials. In the competing renewal, the Clinical Core will support 6 clinical trials within Projects 1, 2 and 3. Project 1 clinical trials include a neoadjuvant study with combined ER and HER2 blockade in patients with ER+/HER2+ operable breast cancers and a pre-surgical study with endocrine blockade in ER+ operable breast cancers;Project 2 clinical trials include a phase I study with paclitaxel/ cisplatin/ RAD001 in metastatic breast cancer patients and a phase II neo-adjuvant study with paclitaxel/cisplatin +/- RAD001 in stage II and III patients with triple-negative breast cancers;and Project 3 clinical trials include a phase I and phase II studies with bisphosphonates, endocrine therapy and TGFbeta antibodies in patients with ER+ metastatic breast cancer and bone metastasis. These studies are the clinical/ translationai complement to the specific aims associated with each of these Project in the Breast Cancer SPORE. Knowledge and insights gained from these trials will be used to design follow-up trials to be conducted in larger, confirmatory trials as inter-SPORE or cooperative group collaborations.
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