Description:
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.
Title
- Brief Title: 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
- 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)
Clinical Trial IDs
- ORG STUDY ID:
M14-011
- SECONDARY ID:
2013-002377-21
- NCT ID:
NCT02032277
Conditions
- Triple Negative Breast Cancer
Interventions
Drug | Synonyms | Arms |
---|
Cyclophosphamide | | Arm A |
Placebo | | Arm C |
Doxorubicin | | Arm A |
Paclitaxel | | Arm A |
Carboplatin | | Arm A |
Veliparib | ABT-888 | Arm A |
Placebo | | Arm B |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Arm A | Active Comparator | Veliparib + carboplatin + paclitaxel followed by doxorubicin/cyclophosphamide (AC) | - Cyclophosphamide
- Doxorubicin
- Paclitaxel
- Carboplatin
- Veliparib
|
Arm C | Placebo Comparator | Placebo + placebo + paclitaxel followed by AC. | - Cyclophosphamide
- Placebo
- Doxorubicin
- Paclitaxel
- Placebo
|
Arm B | Placebo Comparator | Placebo + carboplatin + paclitaxel followed by AC | - Cyclophosphamide
- Doxorubicin
- Paclitaxel
- Carboplatin
- Placebo
|
Eligibility Criteria
Inclusion Criteria:
1. Histologically confirmed invasive breast cancer by core needle or incisional biopsy
(excisional biopsy is not allowed). 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.
Maximum Eligible Age: | 99 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Female |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Pathological Complete Response (pCR). |
Time Frame: | At the time of definitive surgery (approximately 24-36 weeks from first dose of study drug). |
Safety Issue: | |
Description: | Pathological complete response (pCR) in the breast tissue and the lymph node tissue will be assessed upon completion of pre-operative systemic therapy and definitive surgery. |
Secondary Outcome Measures
Measure: | Event Free Survival (EFS) |
Time Frame: | Up to 4 years from the date of definitive surgery. |
Safety Issue: | |
Description: | EFS will be defined as the time from random assignment to documentation of the first of the following events: discontinuation of study therapy due to protocol-defined progression prior to surgery; local, regional, or distant recurrence of breast cancer following curative surgery; a new breast cancer; another new onset malignancy; or death as a result of any cause. |
Measure: | Overall Survival (OS) |
Time Frame: | Up to 4 years from the date of definitive surgery. |
Safety Issue: | |
Description: | OS will be defined as the number of days from the day the subject is randomized to the date of the subject's death. |
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). |
Safety Issue: | |
Description: | Whether a subject is eligible for breast conserving surgery for whom mastectomy was planned at diagnosis will be determined by the subject's surgeon prior to chemotherapy and after completion of chemotherapy. |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Completed |
Lead Sponsor: | AbbVie |
Trial Keywords
- Oncology
- Triple negative breast cancer
- German Breast Group - GBG 81
- United States Oncology - 12152
- National Surgical Adjuvant Breast and Bowel Project - B-56-I
- Alliance - AFT-04
- Grupo Español de Investigación en Cáncer de Mama - GEICAM/2014-02
Last Updated
January 20, 2021