Veliparib and Radiation Therapy before Surgery in Treating Patients with Stage IIB-IV Breast Cancer with Incomplete Response to Chemotherapy

Inclusion Criteria

• INCLUSION CRITERIA FOR OBSERVATION (CONSENT A)
• Patients must have histologically confirmed (by routine hematoxylin [H] & eosin [E] staining) adenocarcinoma of the breast or axillary node; patients with squamous, or metaplastic carcinomas or sarcomas of the breast are NOT eligible
• Patient must have had a bilateral mammogram prior to NAC unless there is only one breast
• Patient must have a medical oncology consult and be recommended to receive or are currently receiving neoadjuvant chemotherapy for a stage IIB through IV carcinoma
• Patients must not have received prior radiation therapy to the involved breast at any time for any reason due to the potential for cumulative toxicities
• INCLUSION CRITERIA FOR TREATMENT WITH VELIPARIB AND RADIATION (CONSENT B)
• Patient must have a history and physical within 2 weeks prior to the start of any protocol therapy (radiation and veliparib)
• Patient must have > 1.0 cm residual in-breast cancer (via positive biopsy) or clinically positive residual nodal disease; incident breast biopsies only permitted prior to POPI to confirm residual disease after NAC
• Absolute neutrophil count (ANC) >= 1000/mm^3
• Platelet count >= 100,000/mm^3
• Hemoglobin >= 9.0 g/dL (after transfusion if required)
• Creatinine serum =< 2.0 mg/dl or creatinine clearance >= 45 mL/min * If calculated creatinine clearance is < 45 mL/min, a 24-hour urine collection for creatinine clearance may be performed
• Bilirubin =< 1.5 mg/dL (=< 3.0 mg/dL with liver metastasis) * Subjects with Gilbert's disease may have bilirubin up to 2.5 mg/dL (or 3.0 mg/dL with liver metastasis)
• Serum glutamic-oxaloacetic transaminase (SGOT) =< 2.5 x upper limit of normal of institution's normal range (ULN) (=< 5.0 x ULN with liver metastasis)
• Serum glutamate-pyruvate transaminase (SGPT) =< 2.5 x ULN (=< 5.0 x ULN with liver metastasis)
• Patients must not be pregnant; women of child-bearing potential must also have a negative pregnancy test within 2 weeks prior to start of protocol therapy (radiation and veliparib)
• Women of childbearing potential must agree to use adequate contraception (one of the following listed below) prior to study entry, for the duration of study participation and up to 2 months following completion of protocol therapy * Total abstinence from sexual intercourse (minimum one complete menstrual cycle) * A vasectomized partner * Hormonal contraceptives (oral, parenteral or transdermal) for at least 3 months prior to study drug administration * Double-barrier method (condoms, contraceptive sponge, diaphragm or vaginal ring with spermicidal jellies or cream)
• Patients must not have a serious medical or psychiatric illness which prevents informed consent or compliance with treatment
• All patients must be informed of the investigational nature of this study and given written informed consent in accordance with institutional and federal guidelines
• Patients must have a performance status 0 or 1 by Eastern Cooperative Oncology Group (ECOG) criteria

Exclusion Criteria

• EXCLUSION CRITERIA FOR CONSENT B
• Women who have a < 1.0 cm or are clinically negative node (cN0) after NAC are not eligible
• Last dose of chemotherapy, immunotherapy, biologic therapy, or investigational therapy, was less than 21 days prior to protocol therapy (radiation and veliparib); there are no limitations on the type or number of prior regimens; hormonal therapy and traztusumab are permitted during POPI
• Bisphosphonates, hormone modification therapy, and trastuzumab (are permitted without restriction)
• Unresolved or unstable, serious toxicity from prior administration of another investigational drug and/or prior anti-cancer treatment
• If female, subject is pregnant or breast-feeding
• Clinically significant and uncontrolled major cardiac, respiratory, renal, hepatic, gastrointestinal, hematologic or neurological/psychiatric disease or disorder, including but not limited to: * Active uncontrolled infection * Symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia * Any other illness condition(s) that could exacerbate potential toxicities, confound safety assessments, require excluded therapy for management, or limit compliance with study requirements; questions regarding inclusion of individual subjects should be directed to the principal investigator (PI)
• Unable to swallow and retain oral medications
• History of seizure disorder
• Known contraindication to enhanced MRI and computed tomography (CT), including but not limited to: * Presence of metal objects within the body such as a cardiac pacemaker, implanted cardiac defibrillator, brain aneurysm clips, cochlear implant, ocular foreign body, or shrapnel * History of immediate or delayed hypersensitivity reaction or other contraindication to contrast agents including but not limited to gadolinium and iodine
• Previous enrollment on another study involving the investigation of veliparib (ABT-888), with the exception of receiving a single dose of study drug
• Consideration by the Investigator, for any reason, that the subject is an unsuitable candidate to receive veliparib (ABT-888) and/or breast irradiation