Testing the Addition of Anti-Cancer Drug, ZEN003694 (ZEN-3694) and PD-1 Inhibitor (Pembrolizumab), to Standard Chemotherapy (Nab-Paclitaxel) Treatment in Patients With Advanced Triple-Negative Breast Cancer

This phase Ib trial tests the safety and tolerability of ZEN003694 in combination with an immunotherapy drug called pembrolizumab and the usual chemotherapy approach with nab-paclitaxel for the treatment of patients with triple negative-negative breast cancer that has spread to other parts of the body (advanced). Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Nab-paclitaxel is an albumin-stabilized nanoparticle formulation of paclitaxel which may have fewer side effects and work better than other forms o

Trial Details

NCT ID
NCT05422794
Phase
PHASE1
Sponsor
National Cancer Institute (NCI)
Status
RECRUITING
Cancer Type
Triple Negative (TNBC) Breast Cancer
Locations (sample)
  • Boston, Massachusetts, United States|42.35843,-71.05977
  • Boston, Massachusetts, United States|42.35843,-71.05977
  • Mineola, New York, United States|40.74927,-73.64068
  • New York, New York, United States|40.71427,-74.00597
  • Columbus, Ohio, United States|39.96118,-82.99879

Key Eligibility Criteria

  • Participants must have a histologically or cytologically confirmed diagnosis of TNBC based on standard criteria for the disease:
  • Estrogen receptor (ER) and progesterone receptor (PR) \< 10% by immunohistochemistry (IHC), and HER2-negative (per current American Society of Clin…
  • If there is more than one histological result available, the most recent sample with ER, PR and HER2 results will be considered for inclusion
  • Patients who have not had ER, PR and HER2 testing and thus, ER, PR and HER2 status is unknown, are not eligible

For full eligibility, visit ClinicalTrials.gov.

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