Talazoparib Before Standard Therapy in Treating Patients With Invasive, BRCA-Mutated Breast Cancer

Summary

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Description

PRIMARY OBJECTIVES: I. To evaluate the feasibility of using talazoparib prior to initiating standard neoadjuvant therapies. II. To evaluate the toxicity profile in women taking talazoparib in the neoadjuvant setting. SECONDARY OBJECTIVES: I. To provide first estimate of clinical response to talazopa...

PRIMARY OBJECTIVES: I. To evaluate the feasibility of using talazoparib prior to initiating standard neoadjuvant therapies. II. To evaluate the toxicity profile in women taking talazoparib in the neoadjuvant setting. SECONDARY OBJECTIVES: I. To provide first estimate of clinical response to talazoparib in the neoadjuvant setting in a pilot trial setting. II. To evaluate biomarkers of therapy efficacy as well as initiate patient derived xenograft (PDX) models: targeted or whole exome sequencing for BRCA pathway mutations and other somatic and germline alterations; ribonucleic acid (RNA) sequencing; evaluation of changes in immune response; transcriptional profile to assess triple negative breast cancer (TNBC) subtype, BRCA-ness signature and putative PARP sensitivity predictors; functional proteomics with reverse phase protein array (RPPA); generate PDX models and mammosphere cultures from patient derived tumors; PTEN, gamma-H2A histone family, member x (gamma-H2A.X), Ki-67 and cleaved caspase 3 by immunohistochemistry (IHC). OUTLINE: Patients receive talazoparib orally (PO) once daily (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. After completion of study treatment, patients are followed up until the day after definitive breast surgery.

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