Phase II Randomized Placebo-Controlled Trial of Cisplatin With or Without ABT-888 (Veliparib) in Metastatic Triple-Negative Breast Cancer and/or BRCA Mutation-Associated Breast Cancer

Inclusion Criteria
Patients must have metastatic breast cancer (stage IV disease) and be human epidermal growth factor receptor 2 (HER2) non-over expressing
Patients must also meet at least one of the following criteria:
Triple negative: histologically confirmed primary and/or metastatic site that is estrogen receptor (ER)-negative (= 1%), progesterone receptor (PR)-negative (= 1%), and HER2-negative
BRCA mutation: reviously confirmed deleterious breast cancer 1, early onset (BRCA1) or breast cancer 2, early onset (BRCA2) germline mutation (documentation required)
Patients must have measurable or non-measurable disease; patients must have a hest/abdominal computed tomography (CT) scan (or positron emission tomography [PET]/CT of diagnostic quality, conventional or spiral) and bone scan prior to registration; if the patient is unable to undergo CT with IV contrast due to allergy or renal insufficiency, a non-contrast CT may be performed; all scans needed for assessment of measurable disease must be performed within 28 days prior to registration; non-measurable disease must be assessed within 42 days prior to registration; all disease must be assessed and documented on the Baseline Tumor Assessment Form
Patients must have adequate tissue available
Patients must have = 1 prior cytotoxic regimens for metastatic disease
Patients must have completed any prior radiation therapy and hormonal therapy at least 14 days prior to registration
Patients must not have received prior cisplatin or poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitors; prior carboplatin in the adjuvant/neoadjuvant setting and prior treatment with iniparib is allowed, if completed more than 6 months prior to study entry
Patients must not have received any chemotherapy within 14 days prior to registration
Patients must not have received any immunotherapy, biologic or any investigational drug within 28 days prior to registration; patients must not have received bevacizumab within 42 days prior to registration
Patients may receive bisphosphonates or denosumab concurrently with study treatment provided it has been started at least 7 days prior to registration
Patients must hve recovered to == grade 2
Patients must be able to swallow whole capsules
Patients with known brain metastases must have clinically controlled neurologic symptoms, defined as surgical excision and/or radiation therapy followed by 14 days of stable neurologic function prior to registration
Patients must not have any incidence of or uncontrolled medical illness (e.g. active cardiac symptoms, active systemic infection, etc.) that would limit the patient's ability to participate in the protocol
Patients must not have baseline peripheral neuropathy that exceeds grade 1
Patients must have a complete history and physical examination within 28 days prior to registration
Patients must not be pregnant or nursing; men and women of reproductive potential must have agreed to use an effective contraceptive method; a woman is considered to be of reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures
No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years
Patients must agree to have specimens submitted for germline deoxyribonucleic acid (DNA) sequencing and other correlative studies
Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
BRAIN METASTASES COHORT
In addition to all of the previous eligibility criteria, patients with progressive brain metastases who do not satisfy the conditions to enroll in the standard cohort (neurologic stability for 14 days following surgery and/or radiation therapy) must also meet the following criteria to enroll as part of the brain metastases cohort:
Patients with progressive brain metastases must have a baseline brain magnetic resonance imaging (MRI) within 28 days prior to registration
Brain metastases must be progressive and >= 10 mm in longest dimension on radiographic imaging AFTER prior intracranial radiation (IR) therapy (i.e., whol brain radiation therapy [WBRT], stereotactic radiosurgery [SRS], gamma knife [GK] or local equivalent)
Patients must not have evidence of diffuse leptomeningeal disease on brain MRI or by previously documented cerebrospinal fluid (CSF) cytology
Discrete dural metastases are permitted; there must be no evidence of hemorrhage or impending herniation on baseline brain imaging
Patients with contraindication to gadolinium-enhanced MRI imaging are not eligible
Patients must be on a stable or decreasing dose of steroids for >= 7 days prior to registration
If patient had an open brain biopsy, at least 28 days must have elapsed between biopsy and registration