A Phase 2 Study of PCS6422 With Capecitabine in Patients With Advanced or Metastatic Breast Cancer

This is an adaptive Phase 2, open-label, randomized, multi-center study evaluating up to 2 regimens of PCS6422 with capecitabine (Cap) vs. standard dose of Cap alone in patients with advanced or metastatic breast cancer. The goal of the study is to assess the efficacy and safety of PCS6422 + Cap as a treatment option for patients with advanced or metastatic breast cancer who are not eligible for anthracycline- or taxane-containing therapies, or other available therapies, including PD-1 or PARP inhibitors.

Trial Details

NCT ID
NCT06568692
Phase
PHASE2
Sponsor
Processa Pharmaceuticals
Status
RECRUITING
Cancer Type
HER2 Positive Breast Cancer
Interventions
  • PCS6422 and capecitabine
  • Capecitabine
Locations (sample)
  • Tucson, Arizona, United States|32.22174,-110.92648
  • Los Angeles, California, United States|34.05223,-118.24368
  • Oxnard, California, United States|34.1975,-119.17705
  • Miami, Florida, United States|25.77427,-80.19366
  • Tampa, Florida, United States|27.94752,-82.45843

Key Eligibility Criteria

  • Aged ≥18 years at Screening
  • Diagnosis of histologically confirmed breast cancer that is unresectable. The following subsets of breast cancer are included:
  • Patients with triple-negative breast cancer, advanced or metastatic
  • Patients with hormone receptor (HR) positive, ER positive, HER2 negative advanced or metastatic breast cancer

For full eligibility, visit ClinicalTrials.gov.

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