A Phase I Study of ASTX727 Plus Talazoparib in Patients With Triple Negative or Hormone Resistant/ Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Metastatic Breast Cancer

  • End date
    Jul 1, 2024
  • participants needed
  • sponsor
    Kathy Miller
Updated on 13 October 2022
breast cancer
endocrine therapy
neutrophil count
hormone therapy
brain metastases
triple negative breast cancer
stage iv breast cancer


This is a Phase I study to test the safety of a combination of ASTX727 with talazoparib in patients with triple negative breast cancer or hormone resistant/HER2-negative metastatic breast cancer


The phase I portion will use a traditional 3 + 3 design and standard definitions of DLT based on toxicity experienced during the first cycle of therapy. Patients with triple negative breast cancer (TNBC) and hormone resistant/HER2 negative (HRBC) metastatic disease will be enrolled and analyzed together during the dose escalation cohorts. Once the maximum tolerated dose is determined, we will enroll a small expansion cohort to further characterize safety and provide preliminary efficacy estimates.The expansion cohort will be limited to 14 patients; 7 with TNBC and 7 with HRBC. The dose level selected for expansion will be based on the totality of the data available including toxicity during the DLT evaluation period, toxicity during subsequent cycles, and correlative results.

Condition Metastatic Breast Cancer, Triple Negative Breast Cancer, Hormone Receptor Positive Tumor
Treatment Talazoparib, ASTX727
Clinical Study IdentifierNCT04134884
SponsorKathy Miller
Last Modified on13 October 2022


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