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Association details:
| Biomarker: | BRCA1 mutation |
|---|---|
| Cancer: | HER2 Negative Breast Cancer |
| Drug: | veliparib (ABT-888) (PARP inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
An Exposure-Response Model with Time-Varying Predictors to Estimate the Effects of Veliparib in Combination With Carboplatin/Paclitaxel and as Monotherapy: Veliparib Phase 3 Study in BRCA-Mutated Advanced Breast Cancer (BROCADE3) Trial
Published date:
04/10/2022
Excerpt:
...evaluating veliparib in combination with carboplatin/paclitaxel with continuation as monotherapy if carboplatin/paclitaxel is discontinued in patients with germline BRCA1/2 mutation-associated, advanced HER2-negative breast cancer...CPH model indicated a flat exposure-response relationship between the veliparib exposure and PFS when veliparib was administered in combination with carboplatin/paclitaxel or as monotherapy....These analyses support the dose regimen of veliparib (120 mg twice daily) in combination with carboplatin/paclitaxel...
Secondary therapy:
carboplatin; paclitaxel
DOI:
https://doi.org/10.1002/jcph.2061
Trial ID:
Source:
Title:
Safety and efficacy of veliparib plus carboplatin/paclitaxel in patients with HER2-negative metastatic or locally advanced breast cancer: subgroup analyses by germline BRCA1/ 2 mutations and hormone receptor status from the phase-3 BROCADE3 trial
Published date:
12/09/2021
Excerpt:
Median PFS was longer in the veliparib arm compared with the placebo arm for all subgroups...gBRCA1: 14.2 vs 12.6 months, hazard ratio (95% CI): 0.75 (0.55, 1.03), p = 0.073; gBRCA2: 14.6 vs 12.6 months, hazard ratio (95% CI): 0.69 (0.50, 0.95); p = 0.021)....Veliparib plus carboplatin/paclitaxel resulted in durable benefit in subgroups defined by HR status or by gBRCA1 versus gBRCA2 mutation.
Secondary therapy:
carboplatin + paclitaxel
DOI:
10.1177/17588359211059601
Trial ID:
Source:
Title:
Efficacy and safety of first-line veliparib and carboplatin-paclitaxel in patients with HER2- advanced germline BRCA+ breast cancer: Subgroup analysis of a randomised clinical trial
Published date:
07/06/2021
Excerpt:
...in patients with germline BRCA-associated locally advanced/metastatic HER2- breast cancer...Patients were randomised 2:1 to receive veliparib (120 mg orally BID) or placebo on days -2 to 5. Carboplatin (AUC 6) was administered on day 1, and paclitaxel (80 mg/m2) on days 1, 8 and 15 (21-day cycles). In the first-line subgroup, median PFS was 16.6 months (95% confidence interval [CI] 13.4-18.7) versus 13.1 months (95% CI 11.4-14.5) for the veliparib versus control groups (hazard ratio 0.70, 95% CI 0.54-0.89, P = .004). More patients were alive and progression-free at 2 years (36% versus 23.2%) and 3 years (27.9% versus 13.3%) in the veliparib versus control group. Veliparib with carboplatin-paclitaxel led to durable disease control among first-line patients, suggesting a benefit of this treatment approach in early lines.
Secondary therapy:
carboplatin + paclitaxel
DOI:
10.1016/j.ejca.2021.05.037
Trial ID:
Source:
Title:
Relevance of Platinum-free Interval and BRCA Reversion Mutations for Veliparib Monotherapy after Progression on Carboplatin/Paclitaxel for gBRCA Advanced Breast Cancer (BROCADE3 Crossover)
Published date:
06/15/2021
Excerpt:
...metastatic or locally advanced unresectable HER2-negative breast cancer and deleterious or suspected deleterious gBRCA1 or gBRCA2 mutations...patients had received ≥1 dose of open-label crossover veliparib monotherapy after progression...within each subgroup, there were patients who were progression free for 12 months or longer (BRCA1, 2 patients; BRCA2, 3 patients; TNBC, 3 patients; hormone receptor positive, 2 patients...
DOI:
10.1158/1078-0432.CCR-21-0748
Trial ID:
Source:
Title:
Safety and efficacy of veliparib plus carboplatin/paclitaxel in patients with HER2-negative metastatic or locally advanced breast cancer: A subgroup analysis of germline BRCA1 or BRCA2 mutations from the phase 3 BROCADE3
Published date:
11/17/2020
Excerpt:
The proportion of as-treated pts with BRCA1 or BRCA2 mutations was comparable between the Vel + C/P (51.4% BRCA1, 48.6% BRCA2) and Pbo + C/P (50.9% BRCA1, 49.1% BRCA2) study arms...Investigator-assessed PFS for the Vel + C/P and Pbo + C/P arms was 14.2 mo vs 12.6 mo, respectively, in the BRCA1 subgroup (HR=0.75 [95% CI: 0.55, 1.03]; P=0.073) and 14.6 mo vs 12.6 mo, respectively, in the BRCA2 subgroup (HR=0.69 [95% CI: 0.50, 0.95]; P=0.021)...
Secondary therapy:
carboplatin + paclitaxel
Trial ID:
Source:
Title:
Veliparib with carboplatin and paclitaxel in BRCA-mutated advanced breast cancer (BROCADE3): a randomised, double-blind, placebo-controlled, phase 3 trial
Published date:
08/27/2020
Excerpt:
...patients were assigned to receive veliparib plus carboplatin-paclitaxel (veliparib group) and 172 were assigned to receive placebo plus carboplatin-paclitaxel (control group). Median follow-up at data cutoff (April 5, 2019) was 35·7 months (IQR 24·9-43·6) in the veliparib group and 35·5 months (23·1-45·9) in the control group....resulted in significant and durable improvement in progression-free survival in patients with germline BRCA mutation-associated advanced breast cancer.
Secondary therapy:
carboplatin + bisphosphonate bound paclitaxel
DOI:
10.1016/S1470-2045(20)30447-2
Trial ID:
Source:
Title:
ES12-1 Clinical indications of PARP1 inhibitors and other targets
Published date:
12/10/2019
Excerpt:
...BROCADE 3 clinical trial examining carboplatin and paclitaxel with the addition of veliparib or placebo...longest progression-free and overall survival to date with PARP inhibitor therapy in advanced germline BRCA1 and BRCA2 mutation-associated breast cancer.
Secondary therapy:
carboplatin + paclitaxel
Source:
Title:
Veliparib, Cisplatin, and Vinorelbine Ditartrate in Treating Patients With Recurrent and/or Metastatic Breast Cancer
Excerpt:
...- Confirmed BRCA1 or BRCA2 mutation associated breast cancer...
Trial ID:
Source:
Title:
Veliparib and Carboplatin in Treating Patients With HER2-Negative Metastatic Breast Cancer
Excerpt:
...- HER negative with a known germline BRCA1/2 mutation...
Trial ID:
More C2 evidence
Source:
Title:
Veliparib in Treating Patients With Malignant Solid Tumors That Do Not Respond to Previous Therapy
Excerpt:
...- Have a documented BRCA1/2 mutation and a BRCA related malignancy (primarily breast or ovarian cancers, but also may include prostate or pancreatic cancers);...
Trial ID:
Source:
Title:
Cyclophosphamide and Veliparib in Treating Patients With Locally Advanced or Metastatic Breast Cancer
Excerpt:
...- Phase I: Patients must have received at least one prior chemotherapy regimen for metastatic disease; patients with deleterious germ line mutations in breast cancer (BRCA)1 or BRCA2 are...
Trial ID:
Source:
Title:
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
Excerpt:
...previously confirmed deleterious breast cancer 1, early onset (BRCA1) or breast cancer 2, early onset (BRCA2) germline mutation or suspected deleterious BRCA1 or BRCA2 germline mutation if the classification being used is the 5-tier classification; documentation of germline test results are required...
Trial ID:
