Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 3 study of Metastatic Breast Cancer, sponsored by AbbVie.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Time to PFS is defined as the number of days from the date the participant was randomized to the date the participant experiences radiographic disease progression (as determined by the investigators), or to the date of death (all causes of mortality) if disease progression is not reached. All events of disease progression occurring on or before the Primary Analysis Cutoff date of 05 April 2019 were to be included, regardless of whether the event occurred while the participant was still taking st
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 |
What the finished NCT02163694 record still lists
NCT02163694 is an interventional study that assigns participants to a tested intervention. The registered 513 participants enrollment target is mid-sized for trials with a published cap, above the 201-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (155% higher).
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 names 20 study sites across 8 states, led by 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.
Learn More About Clinical Trials
Similar trials for Metastatic Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02163694's enrollment target sits among peer trials
513 9th of 139 higher than 131 of 139 other Metastatic Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
The CDK4/6 Inhibitor Dosing Knowledge (CDK) Study
RECRUITING · Phase 3
-
Evaluation of Lasofoxifene Combined With Abemaciclib Compared With Fulvestrant Combined With Abemaciclib in Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation
RECRUITING · Phase 3
-
Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer
RECRUITING · Phase 3
-
Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer
RECRUITING · Phase 3
-
A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer
RECRUITING · Phase 3
-
OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer
RECRUITING · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05691244 · 514 participants · Phase 3
Assess the Safety and Efficacy of Sovateltide in Patients With Acute Cerebral Ischemic Stroke
- NCT06585488 · 514 participants · Phase 1
A First-in-human Study of BGB-53038, a Pan-KRAS Inhibitor, Alone or in Combinations in Participants With Advanced or Metastatic Solid Tumors With KRAS Mutations or Amplification
- NCT06716606 · 514 participants · Phase 3
A Study to Investigate the Long-term Safety and Efficacy of Belimumab in Adults With Interstitial Lung Disease (ILD) Associated With Systemic Sclerosis (SSc) and Other Connective Tissue Diseases (CTD) (BLISSconneCTD-OLE)
- NCT05005403 · 512 participants · Phase 1
Study to Assess Adverse Events and Pharmacokinetics in Adult Participants With Non-Small Cell Lung Cancer (NSCLC), Head and Neck Squamous Cell Carcinoma (HNSCC) and Other Solid Tumors, Receiving Intravenous (IV) Infusion of Azirkitug (ABBV-514) Alone or in Combination With Budigalimab or Bevacizumab
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI