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NCT02163694 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of Metastatic Breast Cancer, sponsored by AbbVie.
- Completed
- Registry status
- Phase 3
- Development phase
- 513
- Enrollment target
- 20
- Study locations
NCT02163694 is a Phase 3 study of Metastatic Breast Cancer that has completed, run by AbbVie. The registered enrollment target is 513 participants, above the 201-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (155% higher). The trial reports 20 study locations across 8 states.
The verdict
NCT02163694, a Phase 3 study of Metastatic Breast Cancer, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 513 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective of the study is to assess the progression-free survival (PFS) of veliparib in combination with carboplatin and paclitaxel (C/P) compared to placebo plus C/P 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 C/P versus placebo in combination with C/P.
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Paclitaxel
- DRUG Veliparib
- DRUG Veliparib Placebo
Study Locations (20)
California
- City of Hope /ID# 127117 - Duarte
- California Cancer Associates for Research & Excellence (cCARE) /ID# 136078 - Fresno
- Moores Cancer Center at UC San Diego /ID# 124991 - La Jolla
- Hematology and Oncology Assoc /ID# 130058 - Newport Beach
- Cancer Research Collaboration /ID# 128860 - Santa Ana
- Icri /Id# 128520 - Whittier
Florida
- Lynn Cancer Institute, Boca /ID# 125013 - Boca Raton
- Holy Cross Hospital /ID# 125012 - Fort Lauderdale
- Sacred Heart Hospital /ID# 128279 - Pensacola
- Moffitt Cancer Center /ID# 124990 - Tampa
- Florida Cancer Specialists - East /ID# 125007 - West Palm Beach
Colorado
- Univ of Colorado Cancer Center /ID# 124983 - Aurora
- Saint Joseph Hospital /ID# 131768 - Denver
Georgia
- Emory Midtown Infectious Disease Clinic /ID# 133192 - Atlanta
- The Cancer Ctr at DeKalb Med C /ID# 125024 - Decatur
Illinois
- University of Illinois - Chicago /ID# 127576 - Chicago
- NorthShore University HealthSystem /ID# 124996 - Evanston
Arizona
- Banner MD Anderson Cancer Ctr /ID# 125011 - Gilbert
Arkansas
- University of Arkansas for Medical Sciences /ID# 124992 - Little Rock
Connecticut
- Norwalk Hospital /ID# 133509 - Norwalk
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 513 participants |
| Start Date | 2014-04-08 |
| Est. Completion | 2024-01-25 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02163694
The ClinicalTrials.gov registry entry for NCT02163694 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 513 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 201-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (155% higher). The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Metastatic Breast Cancer appearing as the primary indexed condition, and to 4 interventions - of which Carboplatin is the first listed.
NCT02163694 reports 20 study locations spanning 8 distinct geographic areas - top geographies include California, Florida, Colorado.
Frequently Asked Questions
What is clinical trial NCT02163694 about?
NCT02163694 is a clinical study titled "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". The primary objective of the study is to assess the progression-free survival (PFS) of veliparib in combination with carboplatin and paclitaxel (C/P) compared to placebo plus C/P in participants with a Breast Cancer Gene 1 or 2 (BRCA1; BRCA2) mutation in Human Epidermal Growth Factor Receptor 2 (HER...
What is the current status of trial NCT02163694?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 513 participants. The study started on 2014-04-08. Estimated completion is 2024-01-25.
What conditions does trial NCT02163694 study?
This clinical trial studies the following conditions: Metastatic Breast Cancer.
What interventions are being tested in trial NCT02163694?
The interventions under investigation include: Carboplatin (DRUG), Paclitaxel (DRUG), Veliparib (DRUG), Veliparib Placebo (DRUG).
Who is sponsoring clinical trial NCT02163694?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02163694 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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