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Association details:
| Biomarker: | BRCA1 mutation |
|---|---|
| Cancer: | Triple Negative Breast Cancer |
| Drug: | veliparib (ABT-888) (PARP inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
140O - Veliparib plus carboplatin-paclitaxel in patients with HER2-negative advanced/metastatic gBRCA-associated breast cancer: Results in hormone receptor-positive and triple-negative breast cancer subgroups from the phase III BROCADE3 trial
Published date:
05/23/2020
Excerpt:
The addition of Vel to C-P improved PFS in gBRCA pts with HR+ BC and TNBC .
Secondary therapy:
carboplatin + paclitaxel
Trial ID:
Source:
Title:
Response to PARP Inhibitor Predicted by the RAD51 Assay
Excerpt:
...Subjects must have triple negative breast cancer (maximum 10% ER expression), platinum sensitive (≥ 6 months since last platinum containing therapy) high grade serous ovarian cancer or BRCA1/2 mutated (non-)breast and (non-)ovarian cancer....
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:
More C2 evidence
Source:
Title:
ABT-888 With Modified FOLFOX6 in Patients With Metastatic Pancreatic Cancer
Excerpt:
...- Personal or known family history of a deleterious (or indeterminate) mutation in the BRCA1, BRCA2, PALBB2, or one of the FANC genes....
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:
Source:
Title:
Phase II ABT-888 With Cyclophosphamide
Excerpt:
...- BRCA-positive ovarian cancer (documented deleterious BRCA1/2 mutation or a BRCAPRO score of greater than or equal to 30%)...
Trial ID:
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:
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:
Expanded Access With ABT-888 (Veliparib) to Treat Metastatic Breast Cancer
Excerpt:
...- Confirmed HER2-, BRCA1 or BRCA2 mutation-associated breast cancer or sporadic triple negative breast cancer....
Trial ID:
Less C2 evidence
Source:
Title:
Efficacy and safety of veliparib in the treatment of advanced/metastatic breast cancer: a meta-analysis of phase II and III randomized controlled trials
Published date:
11/17/2023
Excerpt:
We conducted a meta-analysis to evaluate the efficacy and safety of veliparib in the treatment of advanced/metastatic breast cancer....The pooled analysis provided evidence that veliparib-containing regimens could significantly improve the PFS (HR: 0.71; 95% CI: 0.61-0.83; p < 0.0001), OS (HR: 0.87; 95% CI: 0.76-0.99; p = 0.03), and ORR (RR: 1.52; 95% CI:1.06-2.18; p = 0.02) than those of controls for treating advanced/metastatic breast cancer. Breast cancer patients with BRCA-mutation tended to have a better PFS than the BRCA-wildtype group, and patients with TNBC tended to associated with a longer PFS than the non-TNBC group.
DOI:
https://doi.org/10.1080/1120009X.2023.2281760
Source:
Title:
Cisplatin with veliparib or placebo in metastatic triple-negative breast cancer and BRCA mutation-associated breast cancer (S1416): a randomised, double-blind, placebo-controlled, phase 2 trial
Published date:
02/01/2023
Excerpt:
In the germline BRCA1/2-mutated group, median progression-free survival was 6·2 months (95% CI 2·3–9·2) in the cisplatin plus veliparib group and 6·4 months (4·3–8·2) in the cisplatin plus placebo group (HR 0·79 [95% CI 0·38–1·67]; log-rank p=0·54)....The addition of veliparib to cisplatin significantly improved progression-free survival in patients with BRCA-like metastatic triple-negative breast cancer...
DOI:
https://doi.org/10.1016/S1470-2045(22)00739-2
Trial ID:
Source:
Title:
A phase 1 and pharmacodynamic study of chronically-dosed, single-agent veliparib (ABT-888) in patients with BRCA1- or BRCA2-mutated cancer or platinum-refractory ovarian or triple-negative breast cancer
Published date:
04/18/2022
Excerpt:
This phase I study determined the recommended phase II dose (RP2D) and preliminary efficacy of the PARP inhibitor, veliparib (ABT-888), in these patients....Overall response rate (ORR) was 23% (95% CI 13-35%) in BRCAmut overall, and 37% (95% CI 21-55%) at 400 mg BID and above....There is evidence of clinical activity of veliparib in patients with BRCAmut and BRCAwt cancers.
DOI:
10.1007/s00280-022-04430-6
Source:
Title:
Phase I Study of Veliparib (ABT-888) Combined with Cisplatin and Vinorelbine in Advanced Triple-Negative Breast Cancer and/or BRCA Mutation-Associated Breast Cancer
Excerpt:
Germline BRCA mutation presence versus absence was associated with 6-month progression-free survival [PFS; 10 of 14 (71%) vs. 8 of 27 (30%), mid-P = 0.01]. Median PFS for all 50 patients was 5.5 months (95% confidence interval, 4.1-6.7)...Veliparib at 300 mg twice daily combined with cisplatin and vinorelbine is well tolerated with encouraging response rates.
Secondary therapy:
cisplatin + vinorelbine tartrate
DOI:
10.1158/1078-0432.CCR-15-2137
Source:
Title:
Results of a phase II randomized trial of cisplatin +/- veliparib in metastatic triple-negative breast cancer (TNBC) and/or germline BRCA-associated breast cancer (SWOG S1416).
Excerpt:
Numerically better OS (median OS 13.7 vs 12.1 months, HR=0.66; p=0.14) and ORR (45% vs 35%, p=0.38) were noted with Vel vs P in BRCA-like group. Non-BRCA-like group did not show benefit of veliparib for PFS (HR=0.85; p=0.43) neither did the unclassified group (HR=0.97)....Addition of Vel to cisplatin significantly improved PFS and showed a trend towards improved OS for BRCA-like advanced TNBC.
Secondary therapy:
cisplatin
DOI:
10.1200/JCO.2020.38.15_suppl.1001
Trial ID:
