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
CompletedPhase 2Results postedLast updated 8 April 2026
What this trial tests
Phase 2 trial testing Cisplatin in Metastatic BRCA Hereditary Breast Carcinoma in 344 participants. Completed in 21 March 2025.
18 and older, any sex, with Metastatic BRCA Hereditary Breast Carcinoma or Metastatic Breast Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Progression-free Survival (PFS)Primary· Time from registration (randomization) to progression or death due to any cause, assessed up to 5 years
Veliparib will be compared to no veliparib in the BRCA mutation-carriers, BRCA mutation-negative BRCAness-like group, and BRCA mutation-negative non-BRCA-like group. A stratified log-rank test will be used to compare PFS between the two arms in an intention to treat (ITT) analysis where stratification is by line of therapy. A stratified log-rank test will be used to compare PFS between the two arms in an ITT analysis where stratification is by Modified Breast-Graded Prognostic Assessment (GPA) and prior systemic therapies.
Progression is defined as radiologic progression of disease by RECIST
germline BRCA1/2-mutated
Group
Value
95% CI
Arm I (Cisplatin and Placebo)
6.4
4.3 – 8.2
Arm II (Cisplatin and Veliparib)
6.2
2.3 – 9.2
BRCA-like
Group
Value
95% CI
Arm I (Cisplatin and Placebo)
4.2
2.3 – 5.0
Arm II (Cisplatin and Veliparib)
5.9
4.3 – 7.8
non-BRCA-like
Group
Value
95% CI
Arm I (Cisplatin and Placebo)
3.0
2.2 – 4.4
Arm II (Cisplatin and Veliparib)
4.0
2.5 – 4.7
Overall Survival (OS)Secondary· Time from registration to death due to any cause, assessed up to a minimum of 5 years
Veliparib will be compared to no veliparib in the BRCA mutation-carriers, BRCA mutation-negative BRCAness-like group, and BRCA mutation-negative non-BRCA-like group. A stratified log-rank test will be used to compare OS between the two arms in an ITT analysis where stratification is line by line. In the Progressive Brain Metastases Cohort, veliparib will be compared to no veliparib in patients with active brain metastases that are progressive after prior intracranial therapy. A stratified log-rank test will be used to compare OS between the two arms in an ITT analysis where stratification is b
germline BRCA1/2-mutated
Group
Value
95% CI
Arm I (Cisplatin and Placebo)
15.6
12.6 – 21.4
Arm II (Cisplatin and Veliparib)
14.2
8.1 – 21.0
BRCA-like
Group
Value
95% CI
Arm I (Cisplatin and Placebo)
12.1
9.0 – 15.9
Arm II (Cisplatin and Veliparib)
14.0
10.3 – 20.2
non-BRCA
Group
Value
95% CI
Arm I (Cisplatin and Placebo)
11.1
8.2 – 16.1
Arm II (Cisplatin and Veliparib)
10.9
8.5 – 13.1
Response Rate (Measurable Disease Only)Secondary· Up to 5 years
Response rate will be analyzed for patients with measurable disease. Patients who achieve complete or partial response will be classified as having a response. The primary analyses will be conducted using these binary responses using Fisher's exact test and logistic regression.
Complete Response: Complete disappearance of all target and non-target lesions (with the exception of lymph nodes mentioned below). No new lesions. No disease related symptoms.
Partial Response: Applies only to patients with at least one measurable lesion. Greater than or equal to 30% decrease under baseline of the su
germline BRCA-like
Group
Value
95% CI
Arm I (Cisplatin and Placebo)
12
Arm II (Cisplatin and Veliparib)
21
non-BRCA
Group
Value
95% CI
Arm I (Cisplatin and Placebo)
8
Arm II (Cisplatin and Veliparib)
8
Clinical Benefit RateSecondary· Up to 5 years
Clinical benefit will be assessed in patients with measurable disease. The primary analyses will be conducted using these binary responses using Fisher's exact test and logistic regression.
BRCA-like
Group
Value
95% CI
Arm I (Cisplatin and Placebo)
20
Arm II (Cisplatin and Veliparib)
26
non-BRCA
Group
Value
95% CI
Arm I (Cisplatin and Placebo)
21
Arm II (Cisplatin and Veliparib)
23
Adverse events — posted to ClinicalTrials.gov
Time frame: 5 years or until death..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Arm I (Cisplatin and Placebo)
Serious: 53/158 (34%)
Deaths: 135/158
Arm II (Cisplatin and Veliparib)
Serious: 47/162 (29%)
Deaths: 133/162
Serious adverse events (94 terms)
Reaction
System
Arm I (Cisplatin and Place…
Arm II (Cisplatin and Veli…
Nausea
Gastrointestinal disorders
—
—
Vomiting
Gastrointestinal disorders
—
—
Dyspnea
Respiratory, thoracic and mediastinal disorders
—
—
Thromboembolic event
Vascular disorders
—
—
Anemia
Blood and lymphatic system disorders
—
—
Fever
General disorders
—
—
Infections and infestations-Other
Infections and infestations
—
—
Lung infection
Infections and infestations
—
—
Creatinine increased
Investigations
—
—
Dehydration
Metabolism and nutrition disorders
—
—
Hypokalemia
Metabolism and nutrition disorders
—
—
Neoplasms benign, malignant and unspecified - Other
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Other recruiting trials for Metastatic BRCA Hereditary Breast Carcinoma
Currently open trials in the same condition.
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Cancer Institute (NCI)
Last refreshed: 8 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02595905.