Study on Talazoparib for Treating Metastatic Breast Cancer with BRCA Mutations

Sponsor: Massachusetts General Hospital

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03990896

Provider View

This clinical trial is testing the effectiveness of Talazoparib, a drug that targets specific proteins involved in DNA repair, in treating metastatic breast cancer with BRCA 1 or BRCA 2 mutations.

Patient Parameters

Program Overview

The purpose of this study is to evaluate how well Talazoparib works in treating metastatic breast cancer in patients who have a BRCA mutation in their tumor. Talazoparib is a type of drug known as a PARP inhibitor, which can help kill cancer cells by stopping them from repairing their DNA. This study is a Phase II trial, which means it is testing the safety and effectiveness of Talazoparib for this specific type of cancer. Although Talazoparib is not yet approved by the FDA for this particular use, it has been approved for other types of breast cancer with inherited BRCA mutations.

Description

This study is focused on understanding how effective Talazoparib is for patients with metastatic breast cancer that has a BRCA mutation. Talazoparib works by blocking proteins called PARPs, which help repair DNA in cells. When these proteins are blocked, cancer cells with damaged DNA may die. This study is in Phase II, meaning it is testing both the safety and effectiveness of Talazoparib for this specific condition. While Talazoparib is approved for some breast cancers with inherited BRCA mutations, it is still being studied for other types, like the one in this trial.

Participants in this study will receive Talazoparib to see if it can reduce tumor size and slow cancer growth. The study will also monitor any side effects and overall health of the participants during the treatment.

Eligibility Criteria

Inclusion Criteria

  • Have metastatic breast cancer with a specific BRCA 1 or 2 mutation found in the tumor.
  • Have triple negative breast cancer that has worsened after at least one chemotherapy treatment, or hormone receptor positive, HER2 negative cancer that has worsened after endocrine therapy.
  • Have cancer that can be measured or evaluated by doctors.
  • Have not progressed while on platinum-based chemotherapy or within 6 months after finishing it.
  • Be at least 18 years old.
  • Be in good overall health with an ECOG performance status of 0 to 2.
  • Have adequate organ function based on specific blood tests.
  • Have stable central nervous system disease if previously treated.
  • Women of childbearing potential must have a negative pregnancy test and use effective birth control during the study and for 7 months after.
  • Men must agree to use contraception and not donate sperm during the study and for 7 months after.
  • Be willing to provide written informed consent.

Exclusion Criteria

  • Have received an investigational drug within 4 weeks before starting the study.
  • Have been treated with a PARP inhibitor before.
  • Have an inherited BRCA 1 or 2 mutation.
  • Have had recent chemotherapy, targeted therapy, or radiation therapy within 2 weeks before starting the study.
  • Have another active cancer that needs treatment, except for certain skin cancers or in situ cervical cancer.
  • Have untreated cancer spread to the brain or spinal cord.
  • Have any condition or treatment that might interfere with the study.
  • Have psychiatric or substance abuse issues that would affect participation.
  • Be pregnant or breastfeeding, or planning to conceive or father a child during the study and for 7 months after.
  • Have a history of HIV, active Hepatitis B or C.
  • Be taking strong P-glycoprotein inhibitors or other anti-cancer therapies.

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