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Association details:
| Biomarker: | BRCA1 mutation |
|---|---|
| Cancer: | Breast Cancer |
| Drug: | veliparib (ABT-888) (PARP inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Veliparib monotherapy following carboplatin/paclitaxel plus veliparib combination therapy in patients with germline BRCA-associated advanced breast cancer: results of exploratory analyses from the phase III BROCADE3 trial
Published date:
11/30/2021
Excerpt:
Veliparib monotherapy following carboplatin/paclitaxel plus veliparib combination therapy in patients with germline BRCA-associated advanced breast cancer...In this blinded monotherapy subgroup, investigator-assessed median PFS from randomization was 25.7 months with veliparib versus 14.6 months with placebo….Veliparib maintenance monotherapy had a tolerable safety profile and may extend PFS following combination chemotherapy.
DOI:
https://doi.org/10.1016/j.annonc.2021.11.018
Trial ID:
Source:
Title:
Veliparib, Oxaliplatin, and Capecitabine in Treating Patients With Advanced Solid Tumors
Excerpt:
...- BRCA1/2 mutation and a BRCA-related malignancy...
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:
More C2 evidence
Source:
Title:
A Study to Evaluate the Safety, Pharmacokinetics and Oral Bio Availability of Veliparib in Subjects With Solid Tumors
Excerpt:
...Subjects must also 1) have a documented BRCA1 or BRCA2 mutation that is considered to be deleterious by the investigator, OR 2) have high grade serous ovarian, fallopian tube, or peritoneal cancer....
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:
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:
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:
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:
ABT-888 and Temozolomide for Metastatic Breast Cancer and BRCA1/2 Breast Cancer
Excerpt:
...To determine Safety and Efficacy in an Expansion Cohort of BRCA1/2 Mutation Carriers....
Trial ID:
Source:
Title:
Study Evaluating Efficacy And Tolerability Of Veliparib in Combination With Temozolomide (TMZ) or In Combination With Carboplatin and Paclitaxel Versus Placebo in Participants With Breast Cancer Gene (BRCA)1 and BRCA2 Mutation and Metastatic Breast Cancer
Excerpt:
...- Must have a documented deleterious Breast Cancer Gene BRCA1 or BRCA2 germline mutation....
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:
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 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 and Carboplatin in Treating Patients With HER2-Negative Metastatic Breast Cancer
Excerpt:
...- HER negative with a known germline BRCA1/2 mutation...
Trial ID:
Less C2 evidence
Source:
Title:
Exposure-response analysis to inform the optimal dose of veliparib in combination with carboplatin and paclitaxel in BRCA-mutated advanced breast cancer patients
Published date:
08/29/2019
Excerpt:
The exposure-response analysis suggested that intermittent 7-day veliparib 120 mg BID dosing in a 21-day cycle provided additional efficacy without meaningfully impacting the safety and tolerability when co-administered with carboplatin and paclitaxel in patients with BRCA-deficient breast cancer.
Secondary therapy:
carboplatin + paclitaxel
DOI:
10.1007/s00280-019-03930-2
Source:
Title:
Abstract S2-05: Efficacy and tolerability of veliparib (V; ABT-888) in combination with carboplatin (C) and paclitaxel (P) vs placebo (Plc)+C/P in patients (pts) with BRCA1 or BRCA2 mutations and metastatic breast cancer: A randomized, phase 2 study
Excerpt:
A total of 196 pts (193 BRCA+ per central lab) were randomized to receive double blinded V+C/P (n=97) or Plc+C/P (n=99)….The V+C/P arm demonstrated numeric improvements for both PFS and OS compared to the Plc+C/P arm; improvement in ORR was statistically significant...This is the first randomized phase 2 trial of a PARP inhibitor in combination with platinum-based therapy for treatment of BRCA1/2-mutated advanced breast cancer. V+C/P demonstrated significantly higher ORR and symptom improvement compared to Plc+C/P, with nonsignificant trends for improved OS and PFS.
Secondary therapy:
carboplatin + paclitaxel
DOI:
10.1158/1538-7445.SABCS16-S2-05
Trial ID:
