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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

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ClinicalTrials.gov Identifier: NCT02032277
Recruitment Status : Active, not recruiting
First Posted : January 10, 2014
Last Update Posted : May 10, 2018
Sponsor:
Collaborators:
German Breast Group
NSABP Foundation Inc
Grupo Español de Investigación del Cáncer de Mama
US Oncology Research
Alliance for Clinical Trials in Oncology
Information provided by (Responsible Party):
AbbVie

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 634 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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)
Actual Study Start Date : April 10, 2014
Actual Primary Completion Date : March 18, 2016
Estimated Study Completion Date : November 2, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Carboplatin
U.S. FDA Resources

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
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



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 10 years from first dose of study drug. ]
    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. 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.

  3. Overall Survival (OS) [ Time Frame: Up to 10 years from first dose of study drug. ]
    OS will be defined as the number of days from the day the subject is randomized to the date of the subject's death.


Other Outcome Measures:
  1. 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). ]
    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.

  2. 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). ]
    ECOG performance status will be determined by the Investigator at each assessment.

  3. 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). ]
    RCB in the breast tissue and the lymph node tissue will be performed after the completion of neoadjuvant systemic therapy.

  4. Clinical Response Rate (CRR) [ Time Frame: First day of treatment on Chemotherapy Segment 2 (approximately 12-16 weeks from first dose of study drug). ]
    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 radiographic response of the primary tumor as determined by the central imaging vendor.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
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.

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


  Show 153 Study Locations
Sponsors and Collaborators
AbbVie
German Breast Group
NSABP Foundation Inc
Grupo Español de Investigación del Cáncer de Mama
US Oncology Research
Alliance for Clinical Trials in Oncology
Investigators
Study Director: AbbVie Inc. AbbVie

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02032277     History of Changes
Other Study ID Numbers: M14-011
2013-002377-21 ( EudraCT Number )
First Posted: January 10, 2014    Key Record Dates
Last Update Posted: May 10, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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:
Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Liposomal doxorubicin
Veliparib
Albumin-Bound Paclitaxel
Cyclophosphamide
Carboplatin
Doxorubicin
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