Phase 2
N=344
Cisplatin With or Without Veliparib in Treating Patients With Recurrent or Metastatic Triple-Negative and/or BRCA Mutation-Associated Breast Cancer With or Without Brain Metastases
Metastatic BRCA Hereditary Breast Carcinoma · Metastatic Breast Carcinoma · Metastatic Malignant Neoplasm in the Brain · Metastatic Triple-Negative Breast Carcinoma · Recurrent Breast Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT02595905 ↗Enrolled (actual)
344
Serious AEs
31.3%
Results posted
Apr 2026
Primary outcome: Primary: Progression-free Survival (PFS) — 6.4; 6.2; 4.2; 5.9 months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Cisplatin (Drug); Laboratory Biomarker Analysis (Other); Placebo Administration (Other); Veliparib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Jan 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival (PFS) |
6.4; 6.2; 4.2; 5.9; 3.0; 4.0 | — |
| SECONDARY Overall Survival (OS) |
15.6; 14.2; 12.1; 14.0; 11.1; 10.9 | — |
| SECONDARY Response Rate (Measurable Disease Only) |
12; 21; 8; 8 | — |
| SECONDARY Clinical Benefit Rate |
20; 26; 21; 23 | — |
Summary
This randomized phase II trial studies how well cisplatin works with or without veliparib in treating patients with triple-negative breast cancer and/or BRCA mutation-associated breast cancer that has come back (recurrent) or has or has not spread to the brain (brain metastases). Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. PARPs are proteins that help repair DNA mutations. PARP inhibitors, such as veliparib, can keep PARP from working, so tumor cells can't repair themselves, and they may stop growing. It is not yet known if cisplatin is more effective with or without veliparib in treating patients with triple-negative and/or BRCA mutation-associated breast cancer.
Eligibility Criteria
Inclusion Criteria
- Patients must have metastatic and/or recurrent (distant or locoregionally recurrent) breast cancer and be HER2 non-over expressing per 2013 American Society of Clinical Oncology (ASCO)-College of American Pathologists (CAP) HER testing guidelines (0 or 1+ by immunohistochemistry [IHC]; and/or HER2 ratio = 1,500/mL (within 21 days prior to registration); patients must not have had a blood transfusion within 28 days prior to registration
- Hemoglobin >= 10 g/dL (within 21 days prior to registration); patients must not have had a blood transfusion within 28 days prior to registration
- Platelet count >= 100, 000/ mL (within 21 days prior to registration); patients must not have had a blood transfusion within 28 days prior to registration
- Bilirubin = = 10 mm in longest dimension on radiographic imaging AFTER prior intracranial radiation (IR) therapy (i.e., whole 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
- Patients enrolling in the Progressive Brain Metastases Cohort can have received up to 3 prior lines of cytotoxic chemotherapy for metastatic disease; note that for enrollment in the standard cohort, patients must have had = = grade 2
- Patients must not have treatment-related acute myeloid leukemia (AML) (t-AML)/myelodysplastic syndrome (MDS) or features suggestive of AML/MDS
- Patients must not have had prior allogeneic bone marrow transplant or double umbilical cord blood transplantation
- 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
Data sourced from ClinicalTrials.gov (NCT02595905). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.