Phase 2
Completed N=74
Veliparib With or Without Carboplatin in Treating Patients With Stage III or IV Breast Cancer
Anatomic Stage III Breast Cancer AJCC v8 · Anatomic Stage IV Breast Cancer AJCC v8 · Locally Advanced Breast Carcinoma · Metastatic Breast Carcinoma
Source: ClinicalTrials.gov NCT01149083 ↗
Enrolled (actual)
74
Serious AEs
41.7%
Results posted
Aug 2025
Primary outcomePrimary: Number of Subject With Overall Response — 15; 3; 8 Participants
Summary
This phase II trial studies how well veliparib with or without carboplatin works in treating patients with stage III or IV breast cancer. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin, 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. It is not yet known whether veliparib is more effective with or without carboplatin in treating breast cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subject With Overall Response |
15; 3; 8 | — |
| PRIMARY Progression-free Survival |
8.7; 3.6; 6.6 | — |
| SECONDARY Maximum Tolerated Dose (MTD) |
150 | — |
| SECONDARY Number of Participants With at Least One Dose Limiting Toxicity (DLT) - Phase I |
2; 1; 0; 0; 3 | — |
| SECONDARY Overall Survival |
18.8; 11.9; 14.7 | — |
Eligibility Criteria
Inclusion Criteria
- Patients must be female, and must have histologically confirmed breast cancer that is metastatic or locally advanced, unresectable and for which standard curative measures do not exist or are no longer effective
- Patients must have a known deleterious BRCA mutation confirmed by report from a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory (generally Myriad Genetics Laboratory). It is expected that BRCA testing will be covered as medically necessary care by the patient's insurance carrier
- Measurable disease by RECIST criteria; (evaluable disease is allowed only for the safety lead-in phase)
- Prior chemotherapy regimens for metastatic disease are completed, at least 3 weeks prior to starting therapy; prior radiation and hormonal treatment must be completed at least 1 week prior to starting therapy
- Female, age >= 18 years. Because no dosing or adverse event data are currently available on the use of ABT-888 in patients = 1,500/mcL
- Platelets >= 100,000/mcL
- Total bilirubin = = 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
- If a woman is of child-bearing potential, a negative serum or urine pregnancy test is required; (The effects of ABT-888 [NSC 737664] on the developing human fetus are unknown; for this reason and because PARP Inhibitor agents are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; participants should agree to use contraception for at least 3 months after the completion of study therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.)
- Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria
- Prior therapy with platinum agents (adjuvant therapy with platinum agents is allowed, if completed >= 12 months prior to relapse), or PARP inhibitors (prior iniparib, since it is no longer considered a PARP inhibitor, is allowed)
- Patients may not be receiving any other investigational agents
- Patients with known central nervous system (CNS) metastases requiring anticonvulsive medications, or steroids or with active symptomatology; patients on anticonvulsant medications prescribed for reasons other than CNS metastases, not on steroids and without active symptomatology are eligible; patients must be off anti-seizure medications and steroids for 3 months or more before enrollment
- Patients with active seizure or a history of seizure; patients with CNS metastases must be stable after therapy for > 3 months and off steroid treatment prior to study enrollment
- History of allergic reactions attributed to compounds of similar chemical or biological composition to ABT-888 (NSC 737664) or PARP inhibitors
- Patients with contraindications to platinum agents are excluded
- Prior or current non-breast malignancy within 5 years except non-melanoma skin cancer or resected stage I ovarian cancer
- Patients with any non-malignant intercurrent illness (e.g., cardiovascular, pulmonary, or central nervous system disease) which is either poorly controlled with currently available treatment or which is of such severity that the investigators deem it unwise to enter the patient on protocol
- Pregnant women are excluded from this study because ABT-888 (NSC 737664) has the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ABT-888 (NSC 737664), breastfeeding should be discontinued
- Patients unable to swallow the ABT-888 tablets whole are ineligible; (the tablets cannot be crushed or broken)
- Patients with an active severe infection; known infection with human immunodeficiency virus (HIV), hepatitis B
Data sourced from ClinicalTrials.gov (NCT01149083). 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. Informational only — not medical advice.