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A Study Evaluating Safety and Efficacy of the Addition of ABT-888 Plus Carboplatin Versus the Addition of Carboplatin to Standard Chemotherapy Versus Standard Chemotherapy in Subjects With Early Stage Triple Negative Breast Cancer

NCT02032277 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 634

Last updated 2021-01-20

No results posted yet for this study

Summary

This is a 3 arm Phase 3 study to evaluate the safety and efficacy of the addition of veliparib plus carboplatin versus the addition of carboplatin to standard neoadjuvant chemotherapy versus standard neoadjuvant chemotherapy in subjects with early stage TNBC.

Conditions

Interventions

DRUG

Cyclophosphamide

Cyclophosphamide

DRUG

Placebo

Placebo for Carboplatin

DRUG

Doxorubicin

Doxorubicin

DRUG

Paclitaxel

Paclitaxel

DRUG

Carboplatin

Carboplatin

DRUG

Veliparib

Veliparib

DRUG

Placebo

Placebo for Veliparib

Sponsors & Collaborators

  • GBG Forschungs GmbH

    collaborator OTHER

  • NSABP Foundation Inc

    collaborator NETWORK

  • Grupo Español de Investigación del Cáncer de Mama

    collaborator UNKNOWN

  • US Oncology Research

    collaborator INDUSTRY

  • AbbVie

    lead INDUSTRY

Principal Investigators

  • AbbVie Inc. · AbbVie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-02
Primary Completion
2016-03-18
Completion
2020-11-12
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • Czechia
  • France
  • Germany
  • Hungary
  • Italy
  • Netherlands
  • Russia
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02032277 on ClinicalTrials.gov