A Phase I Study of ASTX727 plus Talazoparib in Patients with Triple Negative or Hormone Resistant/HER2-negative Metastatic Breast Cancer

Overview

The purpose of this study is to test the safety of a combination of two drugs, ASTX727 (cedazuridine and decitabine) with talazoparib in patients with triple negative breast cancer or hormone resistant/HER2-negative metastatic breast cancer.

Description

The study therapy period will be divided into cycles, each lasting 28 days. The study drugs are both pills and will be taken by mouth on the following schedule: Talazoparib will be taken daily and the ASTX727 will be taken on days 1 through 5, 1 through 4, or 1 through 3 of the cycle depending on what dose level participants are assigned.

Participants will have visits with the study doctor, blood draws, and scans throughout the study that are part of standard of care (participants would have these done whether they were in the study or not). Researchers will also collect additional blood samples and tissue samples in some patients for research purposes only.

Participants will continue to be treated with talazoparib and ASTX727 until their disease gets worse, they withdraw consent from the study, or if they experience side effects that cause them to stop treatment.

Eligibility

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

  • Conditions: Triple Negative Breast Cancer, Hormone Resistant/HER2-negative Metastatic Breast Cancer
  • Age: Between 18 Years - 100 Years
  • Gender: Male or Female

Individuals at least 18 years of age with locally recurrent or metastatic breast cancer.

Individuals with known deleterious BRCA mutation will not be eligible.

Individuals with HER2+ disease, active or symptomatic CNS disease, or active malignancy other than breast cancer will not be eligible.

Women who are pregnant will not be eligible.

Updated on 20 Nov 2022 . Study ID: 1908475334
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