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

StatusTerminated
PhasePhase 2
Started

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Record History

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  1. Trial terminated Sponsor's reason: Business Reason Show 5 more changesShow less
    • Final enrollment: 20 participants (planned 90)
    • Primary completion date changed from estimate of Sep 2026 to Jul 29, 2026
    • Study sites: 13 to 12
    • Eligibility criteria expanded, about 22 words
    • Secondary endpoints: details revised at 3 of 4 entries
  2. Study sites: 12 to 13v5
  3. Study sites: 9 to 12v4
  4. Study sites: 3 to 9v3
  5. Study sites: 2 to 3
    • Start date changed from estimate of Aug 2024 to Oct 2, 2024
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Number NCT06568692
Lead Sponsor Processa Pharmaceuticals
Conditions
(from sponsor)		 Breast Cancer, TNBC - Triple-Negative Breast Cancer, HER2-negative Breast Cancer
Related terms Breast Neoplasms, Triple Negative Breast Neoplasms
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov