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Treatment Study of Germline BRCA 1/2 Mutation Patients with Early Triple Negative Breast Cancer

Clinical Trial Title: 
A phase 2, non-randomized, open-label, single arm, multi-center study of talazoparib for neoadjuvant treatment of germline BRCA 1/2 mutation patients with early triple negative breast cancer.
Clinical Trial Protocol ID: 
18031601
Clinical Trial Investigator Name: 
Lydia Usha, MD
Clinical Trial Protocol Description: 

The purpose of the study is to determine if the study drug talazoparib is safe when given as a neoadjuvant (a first step to shrink a tumor before the main treatment) breast cancer treatment for germline BRCA 1/2 invasive triple-negative breast cancer, and to evaluate how the tumor responds to the drug.

Clinical Trial Eligibility Criteria: 

In order to participate you must meet the following criteria:

  • Are at least 18 years of age at enrollment.
  • Have germline BRCA 1/2 mutation positive, invasive triple-negative breast cancer.
  • Have no evidence of distant metastasis.
  • Have adequate bone marrow, hepatic and renal function.

You will be excluded from the study if any of the following criteria apply to you:

  • Have any other previous antitumor therapies for the current cancer event. Treatment for ductal carcinoma in situ (DCIS) is allowed.
  • Have inflammatory breast carcinoma.
  • Have had previous or concomitant systemic anti-cancer therapies used for the treatment of cancer in the last 3 years.

This is a partial list of inclusion and exclusion criteria.

Clinical Trial Area: 
Breast Cancer
Contact Phone: 
(312) 942-2993
Contact Name: 
Chelsea McPeek, RN