^
    Back
    Association details:
    Biomarker:BRCA1 mutation
    Cancer:Triple Negative Breast Cancer
    Drug:veliparib (ABT-888) (PARP inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    ESMO-BC-I 2020
    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:
    BROCADE3
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    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:
    NCT00892736
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    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:
    NCT01306032
    More C2 evidence
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    J Chemother
    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
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    Lancet Oncol
    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:
    NCT02595905
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    Cancer Chemother Pharmacol
    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
    Evidence Level:
    Sensitive: C3 – Early Trials
    New
    Source:
    J Clin Oncol
    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:
    NCT02595905
    Evidence Level:
    Sensitive: C3 – Early Trials
    New
    Source:
    Clin Cancer Res
    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