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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by AbbVie
Sponsor:
Collaborators:
United States Oncology
NSABP Foundation Inc
Grupo Espanol de Investigacion del Cancer de Mama
Austrian Breast & Colorectal Cancer Study Group
Alliance for Clinical Trials in Oncology
German Breast Group
Information provided by (Responsible Party):
AbbVie
ClinicalTrials.gov Identifier:
NCT02032277
First received: December 13, 2013
Last updated: October 23, 2014
Last verified: October 2014

December 13, 2013
October 23, 2014
April 2014
June 2016   (final data collection date for primary outcome measure)
Pathological Complete Response (pCR). [ Time Frame: At the time of definitive surgery (approximately 24-36 weeks from first dose of study drug). ] [ Designated as safety issue: No ]
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. Subjects who do not complete definitive surgery for reasons other than withdrawal of consent will be considered not to have achieved pCR.
Same as current
Complete list of historical versions of study NCT02032277 on ClinicalTrials.gov Archive Site
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). ] [ Designated as safety issue: No ]
Whether a subject is eligible for breast conserving surgery will be determined by the subject's surgeon prior to chemotherapy and after completion of chemotherapy.
Same as current
  • Event Free Survival (EFS) [ Time Frame: Up to 10 years from first dose of study drug. ] [ Designated as safety issue: No ]
    EFS will be defined as the time from random assignment to documentation of the first of the following events: failure to reach potential curative surgery; local, regional, or distant invasive recurrence of breast cancer following curative surgery; a contralateral breast cancer; a new onset malignancy; or death as a result of any cause.
  • Overall Survival (OS) [ Time Frame: Up to 10 years from first dose of study drug. ] [ Designated as safety issue: No ]
    OS will be defined as the number of days from the day the subject is randomized to the date of the subject's death.
  • Clinical Response Rate (CRR) [ Time Frame: First day of treatment on Chemotherapy Segment 2 (approximately 12-16 weeks from first dose of study drug). ] [ Designated as safety issue: No ]
    CRR at 12 weeks and tumor sizes at 12 weeks will be summarized at the end of the Chemotherapy Segment 1 of the treatment (reported at visit AC1) to assess the objective response rate. CRR is defined as the proportion of subjects with complete or partial response of the primary tumor as determined by the central imaging vendor.
  • pCR plus minimal residual disease (defined as residual cancer burden [RCB] class I) [ Time Frame: At the time of definitive surgery (approximately 24-36 weeks from first dose of study drug). ] [ Designated as safety issue: No ]
    RCB in the breast tissue and the lymph node tissue will be assessed upon completion of pre-operative systemic therapy and definitive surgery.
  • Eastern Cooperative Oncology Group (ECOG) performance status. [ Time Frame: First day of treatment (Day 1) to Pre-Op Visit (approximately 22-32 weeks from first dose of study drug). ] [ Designated as safety issue: No ]
    ECOG performance status will be determined by the Investigator at each assessment.
  • Breast cancer related quality of life (QoL). [ Time Frame: First day of treatment (Day 1) up to 6 months during the post-surgery follow-up period (approximately 15 months from first dose of study drug). ] [ Designated as safety issue: No ]
    Breast cancer related QoL will be assessed via the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30), Breast Cancer module (EORTC QLQ-BR23) and European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L) questionnaires.
Same as current
 
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
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)

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Triple Negative Breast Cancer
  • Drug: Veliparib
    Veliparib
  • Drug: Carboplatin
    Carboplatin
  • Drug: Paclitaxel
    Paclitaxel
  • Drug: Doxorubicin
    Doxorubicin
  • Drug: Cyclophosphamide
    Cyclophosphamide
  • Drug: Placebo
    Placebo for Veliparib
  • Drug: Placebo
    Placebo for Carboplatin
  • Active Comparator: Arm A
    Veliparib + carboplatin + paclitaxel followed by doxorubicin/cyclophosphamide (AC)
    Interventions:
    • Drug: Veliparib
    • Drug: Carboplatin
    • Drug: Paclitaxel
    • Drug: Doxorubicin
    • Drug: Cyclophosphamide
  • Placebo Comparator: Arm B
    Placebo + carboplatin + paclitaxel followed by AC
    Interventions:
    • Drug: Carboplatin
    • Drug: Paclitaxel
    • Drug: Doxorubicin
    • Drug: Cyclophosphamide
    • Drug: Placebo
  • Placebo Comparator: Arm C
    Placebo + placebo + paclitaxel followed by AC.
    Interventions:
    • Drug: Paclitaxel
    • Drug: Doxorubicin
    • Drug: Cyclophosphamide
    • Drug: Placebo
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
624
June 2016
June 2016   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
No
Contact: Stacy Osbaugh, BS 847-937-8646 stacy.osbaugh@abbvie.com
Contact: Juliann Dziubinski, BS 847-937-5838 juliann.dziubinski@abbvie.com
Hungary,   Korea, Republic of,   United States,   Australia,   Czech Republic,   Italy,   Germany
 
NCT02032277
M14-011, 2013-002377-21
Yes
AbbVie
AbbVie
  • United States Oncology
  • NSABP Foundation Inc
  • Grupo Espanol de Investigacion del Cancer de Mama
  • Austrian Breast & Colorectal Cancer Study Group
  • Alliance for Clinical Trials in Oncology
  • German Breast Group
Study Director: Mark McKee, MD AbbVie
AbbVie
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP