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NCT Number: NCT02032277

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 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.

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Key information

Conditions

Triple Negative Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Triple Negative Breast Neoplasms

Age range

18 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

The Tweed Hospital /ID# 120235, Tweed Heads, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Documented Breast Cancer Gene (BRCA) germline mutation testing.
  • Estrogen Receptor (ER)-, Progesterone Receptor (PR)-, and Human Epidermal Growth Factor Receptor (HER)2-negative (triple-negative) cancer of the breast.
  • ECOG Performance status of 0 to 1.
  • 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

  • Previous anti-cancer treatment (cytotoxic chemotherapy, immunotherapy, biologic therapy radiotherapy or investigational agents) with therapeutic intent for current breast cancer.
  • Previous treatment with carboplatin, paclitaxel, doxorubicin, cyclophosphamide and a Poly-(ADP-ribose)-Polymerase (PARP) inhibitor.
  • 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.
  • A history of seizure within 12 months prior to study entry.
  • Pre-existing neuropathy from any cause in excess of Grade 1.

Treatment and study plan

Cyclophosphamide

Drug

Cyclophosphamide

Placebo

Drug

Placebo for Carboplatin

Doxorubicin

Drug

Doxorubicin

paclitaxel

Drug

Paclitaxel

carboplatin

Drug

Carboplatin

Veliparib

Drug

Veliparib

Other names: ABT-888

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Collaborators

  • GBG Forschungs GmbH
  • Grupo Español de Investigación del Cáncer de Mama
  • NSABP Foundation Inc
  • US Oncology Research

Registry information

Official study 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)

Important dates

Study start
2014
Primary completion
2016
Study completion
2020
First posted
Jan 10, 2014
Registry last updated
Jan 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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