This study is currently not recruiting participants.

M14-011; 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)

Study on the Safety and Efficacy of Investigational Medication with Chemotherapy in Early Stage Triple Negative Breast Cancer (TNBC)

Not Recruiting
18 years - 100 years
Female
Phase N/A
1 Location

Brief description of study.

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.

Detailed description of study

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.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Triple Negative Breast Cancer
  • Age: 18 years - 100 years
  • Gender: Female

This study investigates the safety and effectiveness of adding an investigational medication with carboplatin to standard chemotherapy in patients with early stage Triple Negative Breast Cancer (TNBC). Triple Negative Breast Cancer is a type of breast cancer that does not have any of the three common receptors known to fuel most breast cancer growth. Patients will be assigned to one of three study arms to receive different combinations of treatments.

Participants in the study will receive either the investigational medication with carboplatin and standard chemotherapy, carboplatin with standard chemotherapy, or just the standard chemotherapy. The study will monitor the effects of these treatments to understand their safety and how well they work.

  • Who can participate: Participants must have early stage Triple Negative Breast Cancer, be within the specified age range, and meet other criteria defined by the study.
  • Study details: Participants will be divided into three study arms to receive different treatments. One group will receive the investigational medication with carboplatin and standard chemotherapy, another group will receive carboplatin with standard chemotherapy, and the last group will receive only standard chemotherapy.
Updated on 19 Feb 2024. Study ID: 1311863574

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