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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02032277
Recruitment Status : Completed
First Posted : January 10, 2014
Last Update Posted : January 20, 2021
Sponsor:
Collaborators:
German Breast Group
NSABP Foundation Inc
Grupo Español de Investigación del Cáncer de Mama
US Oncology Research
Information provided by (Responsible Party):
AbbVie

Study Description
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Brief 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.

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

Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial.   More info ...

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 634 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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)
Actual Study Start Date : April 2, 2014
Actual Primary Completion Date : March 18, 2016
Actual Study Completion Date : November 12, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Carboplatin

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Arm A
Veliparib + carboplatin + paclitaxel followed by doxorubicin/cyclophosphamide (AC)
 Drug: Cyclophosphamide
Cyclophosphamide

Drug: Doxorubicin
Doxorubicin

Drug: Paclitaxel
Paclitaxel

Drug: Carboplatin
Carboplatin

Drug: Veliparib
Veliparib
Other Name: ABT-888
Placebo Comparator: Arm C
Placebo + placebo + paclitaxel followed by AC.
 Drug: Cyclophosphamide
Cyclophosphamide

Drug: Placebo
Placebo for Carboplatin

Drug: Doxorubicin
Doxorubicin

Drug: Paclitaxel
Paclitaxel

Drug: Placebo
Placebo for Veliparib
Placebo Comparator: Arm B
Placebo + carboplatin + paclitaxel followed by AC
 Drug: Cyclophosphamide
Cyclophosphamide

Drug: Doxorubicin
Doxorubicin

Drug: Paclitaxel
Paclitaxel

Drug: Carboplatin
Carboplatin

Drug: Placebo
Placebo for Veliparib


Outcome Measures
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Primary Outcome Measures :
  1. Pathological Complete Response (pCR). [ Time Frame: At the time of definitive surgery (approximately 24-36 weeks from first dose of study drug). ]
    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 :
  1. Event Free Survival (EFS) [ Time Frame: Up to 4 years from the date of definitive surgery. ]
    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.

  2. Overall Survival (OS) [ Time Frame: Up to 4 years from the date of definitive surgery. ]
    OS will be defined as the number of days from the day the subject is randomized to the date of the subject's death.

  3. 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). ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes 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 T2-3 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02032277


Locations
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Sponsors and Collaborators
AbbVie
German Breast Group
NSABP Foundation Inc
Grupo Español de Investigación del Cáncer de Mama
US Oncology Research
Investigators
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Study Director: AbbVie Inc. AbbVie
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02032277    
Other Study ID Numbers: M14-011
2013-002377-21 ( EudraCT Number )
First Posted: January 10, 2014    Key Record Dates
Last Update Posted: January 20, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by AbbVie:
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
Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Cyclophosphamide
Carboplatin
Doxorubicin
Veliparib
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
 Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Poly(ADP-ribose) Polymerase Inhibitors