A Phase 2 Study of PCS6422 With Capecitabine in Patients With Advanced or Metastatic Breast Cancer
← catalyst calendarNCT06568692 · readout ≤ 42 d
Sponsored by Processa Pharmaceuticals (industry) · PCSA — their whole pipeline →.
Phase
Phase 2
Status
Recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
90estimated
Sites
13
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-10-02 | actual | When the study began enrolling |
| Primary completion | Sep 2026 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Oct 2026 | estimated | The whole study's end, after follow-up |
| First posted | 2024-08-23 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-06-19 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Breast Cancer
- TNBC - Triple-Negative Breast Cancer
- HER2-negative Breast Cancer
Interventions
- Drug: PCS6422 and capecitabine
- Drug: Capecitabine
Primary outcomes
what the primary-completion date above is the date OFEvaluation of Objective Response Rate (ORR)
measured Up to 24 weeks post End of Treatment (EoT)
Number of patients with adverse events (AEs)
measured During treatment, an average of 8 months
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