CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 344 enrolled
Drug / intervention
Cisplatin +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02595905
NCT02595905Phase 2Completed

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, With or Without Brain Metastases

National Cancer Institute (NCI)·interventional·Posted Nov 4, 2015·Updated Apr 8, 2026

In Brief

A Phase 2 clinical trial evaluating Cisplatin, Laboratory Biomarker Analysis, and 2 other interventions for Metastatic BRCA Hereditary Breast Carcinoma and 5 related conditions. Completed, enrolled 344 participants across 810 sites in 2 countries.

Detailed 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.

Study Details

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 4, 2015
Enrollment StartSep 15, 2016
Primary CompletionJan 1, 2025
Study CompletionMar 21, 2025
TodayJul 2, 2026
Enrollment to primary: 8.3 yearsPosted 10.7 years ago

Interventions

Cisplatindrug

Given IV

Laboratory Biomarker Analysisother

Correlative studies

Placebo Administrationother

Given PO

Veliparibdrug

Given PO