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    The value 'Show more Show more Revision: v2.9.0' has been updated to 'Show less MedlinePlus Genetics related topics: Breast cancer MedlinePlus related topics: Breast Cancer Drug Information available for: Talazoparib FDA Drug and Device Resources Show less Design Details Primary Purpose : Treatment Allocation : N/A Interventional Model : Single Group Assignment Masking : None (Open Label) Arms and Interventions Participant Group/Arm Intervention/Treatment Experimental : Treatment (talazoparib) Patients receive talazoparib PO QD on days 1-28. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then proceed to the standard of care therapy of the treating physician's choice. This arm was concluded early after 13 patients. An expansion arm of 20 patients was opened in August 2016 to include at least 4 and up to 6 cycles of talazoparib, followed by surgery to estimate residual cancer burden after therapy with single-agent talazoparib. Other : Laboratory Biomarker Analysis Correlative studies Drug : Talazoparib Given PO Other Names: BMN 673 BMN-673 Primary Outcome Measures Outcome Measure Measure Description Time Frame Number of Participants With Overall Pathological Complete Response (pCR) Pathologic response was documented using the Residual Cancer Burden (RCB) Calculator. Residual cancer burden by ICR will be reported as a categorical variable with four classes (categories) RCB 0 (pCR) which correlates to no invasive disease in breast and lymph, I (minimal RCB), II (moderate RCB), and III (extensive RCB). Up to two fine needle aspirates (FNAs) will also be obtained at each time point for a total of up to 6 FNA's for the trial, which will be used for the patient derived xenograft models. Pre-study biopsies, as well as biopsies within 7 days prior to the completion of 2 months of talazoparib will be collected via diagnostic imaging. During the expansion phase of this trial, ultrasounds will be obtained every 2 cycles (+/- 1 week). Therapy will be discontinued if the Physician or PI indicates clinically significant progression of disease. Up to 6 months Number of Participants With Grade 4 Toxicities To assess the toxicity profile of women taking single agent Talazoparib prior to surgery. If greater than 33% of the patients enrolled have either a grade 4 toxicity possibly, probably, or definitely related to the treatment as attributed by the Principal Investigator, or requires a delay in treatment for greater than 4 weeks due to toxicity. up to 6 months Secondary Outcome Measures Outcome Measure Measure Description Time Frame Median Clinical Response to Single Agent Talazoparib Imaging was the primary measures response with tumor volume shrinkage after 2 months of Talazoparib prior to proceeding with standard chemotherapy for all participants. The clinical response to Talazoparib in the neoadjuvant setting in a pilot trial setting. 2 months Additional Relevant MeSH Terms Neoplasms Neoplasms by Site Breast Diseases Skin Diseases Breast Neoplasms Poly(ADP-ribose) Polymerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Talazoparib Studies a U.S. FDA-Regulated Drug Product Yes Studies a U.S. FDA-Regulated Device Product No Study Documents Provided by M.D. Anderson Cancer Center Study Protocol and Statistical Analysis Plan [ PDF , 0.48MB, 2019-07-29 ] Helpful Links Provided by M.D. Anderson Cancer Center University of Texas MD Anderson Cancer Center Website Revision: v2.9.1'
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