Study of ASTX727 Plus Talazoparib in Patients With Triple Negative or Hormone Resistant/HER2-negative Metastatic Breast Cancer

  • STATUS
    Recruiting
  • End date
    Jul 1, 2023
  • participants needed
    38
  • sponsor
    Kathy Miller
Updated on 7 October 2021
cancer
corticosteroids
breast cancer
endocrine therapy
oophorectomy
metastasis
neutrophil count
hormone therapy
HER2
brain metastases
triple negative breast cancer
stage iv breast cancer
erbb2
talazoparib
mammogram

Summary

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

Description

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.

Details
Condition Breast Cancer, Diet and Nutrition, Chronic Diarrhea, Skin Wounds, Chronic Shoulder Pain, Vaginal Atrophy, Adverse Effects, Drugs, Injection Port, Breast Cancer - HER2 Positive, Anal Dysplasia, Primary Immunodeficiency, Pediatric Health, Near-Sighted Corrective Surgery, Metastatic Breast Cancer, Peripheral Arterial Occlusive Disease, Triple Negative Breast Cancer, Stage IV Breast Cancer, Brain Function, Hormone Receptor Positive Tumor, Recurrent Respiratory Papillomatosis, Razor Bumps (Pseudofolliculitis Barbae), Metastatic Triple-Negative Breast Cancer
Treatment Talazoparib, ASTX727
Clinical Study IdentifierNCT04134884
SponsorKathy Miller
Last Modified on7 October 2021

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