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

Inclusion Criteria:

Signed written informed consent
Histologically confirmed primary invasive adenocarcinoma of the breast with the size of the primary tumor being at least 1 cm on imaging by either mammography, ultrasound or breast magnetic resonance imaging (MRI)
Negative human epidermal growth factor receptor 2 (HER-2)/neu- disease defined as patients with fluorescence in situ hybridization (FISH) ratio < 2.0 or < 6.0 HER2 gene copies per nucleus, and IHC staining scores of 0, 1+, or 2+
No treatment for current primary invasive adenocarcinoma of the breast such as irradiation, chemotherapy, immunotherapy, investigational therapy or surgery; previous treatment for breast and/or ovarian cancer with chemotherapy, endocrine therapy, surgery and radiation are allowed if >= 3 years prior to current diagnosis and there is no clinical evidence of metastatic disease
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Baseline multi gated acquisition scan (MUGA) or echocardiogram scans with left ventricular ejection fraction (LVEF) of > 50%
Absolute neutrophil count (ANC) >= 1,500/uL
Platelets >= 100,000/uL
Hemoglobin (Hgb) >= 9 g/dL
Creatinine clearance > 50 ml/min
Total bilirubin =< 1.5 X upper limit of normal (ULN)
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 X ULN
Negative serum or urine pregnancy test for women within 7 days of receiving the first dose of the study medication for women of childbearing potential; women will be considered not of childbearing potential and exempt from pregnancy testing if they are either a) older than 50 and amenorrheic for at least 12 consecutive months following cessation of all exogenous hormonal treatments, or b) have documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy, but not tubal ligation
Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 8 weeks after the last dose of investigational product; men on study also must be using contraception
Identified deleterious mutation in BRCA 1 or 2 genes (this does not include variants of uncertain significance)
Eligible to receive standard of care chemotherapy and/or surgery based upon standard practices or institutional guidelines

Exclusion Criteria:

Women who are pregnant (including positive pregnancy test at enrollment or prior to study drug administration) or breast-feeding
Disease free of prior malignancy for < 3 years with the exception of curatively treated basal carcinoma of the skin or carcinoma in situ of the cervix
Any other previous antitumor therapies for the current cancer event
Has had major surgery within 21 days before cycle 1 day 1
Gastrointestinal tract disease or defect with associated malabsorption syndrome
Uncontrolled inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis)
Myocardial infarction within 6 months before starting therapy, symptomatic congestive heart failure (New York Heart Association > class II), unstable angina, or unstable cardiac arrhythmia requiring medication
Serious intercurrent infections or non-malignant medical illness that are uncontrolled or the control of which may be jeopardized by this therapy
Psychiatric disorders or other conditions rendering the subject incapable of complying with the requirements of the protocols
Unable to take oral medications
Known to be human immunodeficiency virus positive
Known active hepatitis C virus, or known active hepatitis B virus

Concurrent disease or condition that would interfere with study participation or safety, such as any of the following:

Active, clinically significant infection either grade > 2 by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.03 or requiring the use of parenteral anti-microbial agents within 14 days before day 1 of study drug
Clinically significant bleeding diathesis or coagulopathy, including known platelet function disorders
Non-healing wound, ulcer, or bone fracture
Known hypersensitivity to any of the components of talazoparib