Overview

This trial is active, not recruiting.

Condition triple negative breast cancer
Treatments veliparib, carboplatin, paclitaxel, doxorubicin, cyclophosphamide, placebo
Phase phase 3
Target PARP
Sponsor AbbVie
Collaborator US Oncology Research
Start date April 2014
End date March 2016
Trial size 624 participants
Trial identifier NCT02032277, 2013-002377-21, M14-011

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.

United States Arizona and Florida
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Active Comparator)
Veliparib + carboplatin + paclitaxel followed by doxorubicin/cyclophosphamide (AC)
veliparib
Veliparib
carboplatin
Carboplatin
paclitaxel
Paclitaxel
doxorubicin
Doxorubicin
cyclophosphamide
Cyclophosphamide
(Placebo Comparator)
Placebo + carboplatin + paclitaxel followed by AC
carboplatin
Carboplatin
paclitaxel
Paclitaxel
doxorubicin
Doxorubicin
cyclophosphamide
Cyclophosphamide
placebo
Placebo for Veliparib
(Placebo Comparator)
Placebo + placebo + paclitaxel followed by AC.
paclitaxel
Paclitaxel
doxorubicin
Doxorubicin
cyclophosphamide
Cyclophosphamide
placebo
Placebo for Veliparib
placebo
Placebo for Carboplatin

Primary Outcomes

Measure
Pathological Complete Response (pCR).
time frame: At the time of definitive surgery (approximately 24-36 weeks from first dose of study drug).

Secondary Outcomes

Measure
Rate of eligibility for breast conservation after therapy (BCR).
time frame: At the time of definitive surgery (approximately 24-36 weeks from first dose of study drug).
Event Free Survival (EFS)
time frame: Up to 10 years from first dose of study drug.
Overall Survival (OS)
time frame: Up to 10 years from first dose of study drug.

Eligibility Criteria

Female participants from 18 years up to 99 years old.

Inclusion Criteria: 1. Histologically confirmed invasive breast cancer by core needle or incisional biopsy (excisional biopsy is not allowed). Tumors must be clinical stage T2-3 N0-2 or T1 N1-2 per AJCC Staging Edition 7 or clinical stage T2-3 N0-2 or T1 N1-2 by physical exam or radiologic studies. 2. Documented Breast Cancer Gene (BRCA) germline mutation testing. 3. Estrogen Receptor (ER)-, Progesterone Receptor (PR)-, and Human Epidermal Growth Factor Receptor (HER)2-negative (triple-negative) cancer of the breast. 4. ECOG Performance status of 0 to 1. 5. Women must be determined to be not of childbearing potential (surgically sterile, or postmenopausal defined as amenorrheic for at least 12 months) by the Investigator OR they must have a negative serum pregnancy test prior to randomization. Exclusion Criteria: 1. Previous anti-cancer treatment (cytotoxic chemotherapy, immunotherapy, biologic therapy radiotherapy or investigational agents) with therapeutic intent for current breast cancer. 2. Previous treatment with carboplatin, paclitaxel, doxorubicin, cyclophosphamide and a Poly-(ADP-ribose)-Polymerase (PARP) inhibitor. 3. Concurrent treatment with an ovarian hormonal replacement therapy or with hormonal agents such as raloxifene, tamoxifen or other selective estrogen receptor modulator (SERM). Subjects must have discontinued use of such agents prior to beginning study treatment. 4. A history of seizure within 12 months prior to study entry. 5. Pre-existing neuropathy from any cause in excess of Grade 1.

Additional Information

Official title A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study Evaluating 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 Triple Negative Breast Cancer (TNBC)
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by AbbVie.