Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer

This phase I trial tests the safety, side effects, and best dose of ASTX727 when given in combination with a usual approach of treatment with paclitaxel and pembrolizumab in patients with triple-negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic). The usual approach is defined as care most people get for this type of cancer. The usual approach for patients with metastatic triple negative breast cancer who are not in a study is chemotherapy with drugs like paclitaxel, carboplatin, cisplatin, eribulin, vinorelbine, capecitabi

Trial Details

NCT ID
NCT05673200
Phase
PHASE1
Sponsor
National Cancer Institute (NCI)
Status
RECRUITING
Cancer Type
Triple Negative (TNBC) Breast Cancer
Interventions
  • Biopsy Procedure
  • Biospecimen Collection
  • Computed Tomography
  • Decitabine and Cedazuridine
  • Magnetic Resonance Imaging
  • Paclitaxel
Locations (sample)
  • Phoenix, Arizona, United States|33.44838,-112.07404
  • Costa Mesa, California, United States|33.64113,-117.91867
  • Orange, California, United States|33.78779,-117.85311
  • Sacramento, California, United States|38.58157,-121.4944
  • Jacksonville, Florida, United States|30.33218,-81.65565

Key Eligibility Criteria

  • Patients must have histologically confirmed triple-negative breast cancer (TNBC) (estrogen receptor \[ER\] and progesterone receptor \[PR\] =\< 10%…
  • Age \>= 18 years. Because no dosing or adverse event data are currently available on the use of ASTX727 in combination with pembrolizumab (MK-3475)…
  • Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (or Karnofsky \>= 60%)
  • Absolute neutrophil count (ANC) \>= 1500/mm\^3 (within 14 days prior to registration)

For full eligibility, visit ClinicalTrials.gov.

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