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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

NCT02032277

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 3

Trial Eligibility

Document

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

DrugSynonymsArms
CyclophosphamideArm A
PlaceboArm C
DoxorubicinArm A
PaclitaxelArm A
CarboplatinArm A
VeliparibArm A
PlaceboArm 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

NameTypeDescriptionInterventions
Arm AActive ComparatorVeliparib + carboplatin + paclitaxel followed by doxorubicin/cyclophosphamide (AC)
  • Cyclophosphamide
  • Doxorubicin
  • Paclitaxel
  • Carboplatin
  • Veliparib
Arm CPlacebo ComparatorPlacebo + placebo + paclitaxel followed by AC.
  • Cyclophosphamide
  • Placebo
  • Doxorubicin
  • Paclitaxel
  • Placebo
Arm BPlacebo ComparatorPlacebo + 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). 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.
      
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. 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

Measure:Event Free Survival (EFS)
Time Frame:Up to 10 years from first dose of study drug.
Safety Issue:
Description: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.
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 will be determined by the subject's surgeon prior to chemotherapy and after completion of chemotherapy.
Measure:Overall Survival (OS)
Time Frame:Up to 10 years from first dose of study drug.
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.

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Active, not recruiting
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 12, 2018