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 (Brightness)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by AbbVie
Sponsor:
Collaborators:
United States Oncology
National Surgical Adjuvant Breast and Bowel Project (NSABP)
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: July 11, 2014
Last verified: July 2014
  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.


Condition Intervention Phase
Triple Negative Breast Cancer
Drug: Veliparib
Drug: Carboplatin
Drug: Paclitaxel
Drug: Doxorubicin
Drug: Cyclophosphamide
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.


Estimated Enrollment: 624
Study Start Date: April 2014
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm A
Veliparib + carboplatin + paclitaxel followed by doxorubicin/cyclophosphamide (AC)
Drug: Veliparib
Veliparib
Drug: Carboplatin
Carboplatin
Drug: Paclitaxel
Paclitaxel
Drug: Doxorubicin
Doxorubicin
Drug: Cyclophosphamide
Cyclophosphamide
Placebo Comparator: Arm B
Placebo + carboplatin + paclitaxel followed by AC
Drug: Carboplatin
Carboplatin
Drug: Paclitaxel
Paclitaxel
Drug: Doxorubicin
Doxorubicin
Drug: Cyclophosphamide
Cyclophosphamide
Drug: Placebo
Placebo for Veliparib
Placebo Comparator: Arm C
Placebo + placebo + paclitaxel followed by AC.
Drug: Paclitaxel
Paclitaxel
Drug: Doxorubicin
Doxorubicin
Drug: Cyclophosphamide
Cyclophosphamide
Drug: Placebo
Placebo for Veliparib
Drug: Placebo
Placebo for Carboplatin

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically confirmed invasive breast cancer by core needle or incisional biopsy (excisional biopsy is not allowed). Clinical stage T2-4 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02032277

Contacts
Contact: Stacy Osbaugh, BS 847-937-8646 stacy.osbaugh@abbvie.com
Contact: Juliann Dziubinski, BS 847-937-5838 juliann.dziubinski@abbvie.com

  Show 32 Study Locations
Sponsors and Collaborators
AbbVie
United States Oncology
National Surgical Adjuvant Breast and Bowel Project (NSABP)
Grupo Espanol de Investigacion del Cancer de Mama
Austrian Breast & Colorectal Cancer Study Group
Alliance for Clinical Trials in Oncology
German Breast Group
Investigators
Study Director: Mark McKee, MD AbbVie
  More Information

No publications provided

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02032277     History of Changes
Other Study ID Numbers: M14-011, 2013-002377-21
Study First Received: December 13, 2013
Last Updated: July 11, 2014
Health Authority: United States: Food and Drug Administration
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Netherlands: Ministry of Health, Welfare and Sport
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Canada: Health Canada
Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines
Israel: Ministry of Health
Australia: Department of Health and Ageing Therapeutic Goods Administration
Russia: Ministry of Health of the Russian Federation
Korea: Ministry of Food and Drug Safety
Taiwan : Food and Drug Administration

Keywords provided by AbbVie:
Oncology
Triple negative breast cancer
Austrian Breast and Colorectal Cancer Study Group - ABCSG 44
National Surgical Adjuvant Breast and Bowel Project - B-56-I
United States Oncology - 12152
Alliance - AFT-04
Grupo Español de Investigación en Cáncer de Mama - GEICAM/2014-02
German Breast Group - GBG 81

Additional relevant MeSH terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Liposomal doxorubicin
Doxorubicin
Carboplatin
Paclitaxel
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on August 26, 2014