Ignite Creation Date:
2024-05-06 @ 2:56 AM
Last Modification Date:
2024-10-26 @ 11:26 AM
Study NCT ID:
NCT02163694
Status:
COMPLETED
Last Update Posted:
2024-02-23
First Post:
2014-05-19
Brief Title:
A Phase 3 Randomized Placebo-controlled Trial of Carboplatin and Paclitaxel With or Without Veliparib ABT-888 in HER2-negative Metastatic or Locally Advanced Unresectable BRCA-associated Breast Cancer
Sponsor:
AbbVie
Organization:
AbbVie
Study Overview
Official Title:
A Phase 3 Randomized Placebo-Controlled Trial of Carboplatin and Paclitaxel With or Without the PARP Inhibitor Veliparib ABT-888 in HER2-Negative Metastatic or Locally Advanced Unresectable BRCA-Associated Breast Cancer
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of the study is to assess the progression-free survival PFS of veliparib in combination with carboplatin and paclitaxel CP compared to placebo plus CP in participants with a Breast Cancer Gene 1 or 2 BRCA1 BRCA2 mutation in Human Epidermal Growth Factor Receptor 2 HER2-negative metastatic or locally advanced unresectable breast cancer The secondary objectives of the study are to assess overall survival OS clinical benefit rate CBR through the end of Week 24 objective response rate ORR and PFS on subsequent therapy PFS2 in participants treated with veliparib in combination with CP versus placebo in combination with CP
Detailed Description:
This is a Phase 3 randomized double-blind multinational multicenter study to evaluate the efficacy and tolerability of veliparib in combination with CP compared to placebo in combination with CP in participants with a BRCA1 or BRCA2 mutation as documented by the Sponsor core laboratory with HER2-negative metastatic or locally advanced unresectable breast cancer who received no more than 2 prior lines of cytotoxic therapy for metastatic disease For the purposes of eligibility HER2-negative status was based on the most recent tumor biopsy Participants were randomized in a 21 ratio with a total of approximately 500 participants planned to be randomized Veliparib 120 mgplacebo twice a day BID was dosed Days -2 through 5 with carboplatin target area under the concentration-time curve AUC 6 administered on Day 1 and paclitaxel 80 mgm2 administered weekly on Days 1 8 and 15 of each 21-day cycle
Safety and efficacy data through the prespecified primary analysis cutoff date of 05 April 2019 are included in the interim analysis
Safety and efficacy data through the prespecified primary analysis cutoff date of 05 April 2019 are included in the interim analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2014-000345-70 | EUDRACT_NUMBER | None | None |