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

Processa Pharmaceuticals
NCT IDNCT06568692ClinicalTrials.gov data as of Apr 2026
Phase

Phase 2

Target enrollment

90

Study length

about 2.1 years

Ages

18+

Locations

13 sites in AZ, CA, FL +7

What this study is about

This trial is testing a treatment called PCS6422 with capecitabine (Cap) compared to standard dose of Cap alone for people with advanced or metastatic breast cancer. The goal is to see if PCS6422 + Cap is an effective and safe treatment option for those who can't have anthracycline- or taxane-containing therapies, or other available therapies like PD-1 or PARP inhibitors.

Simplified from trial records by PatientMatch.

What you may be asked to do

  • 1.Take Capecitabine
  • 2.Take PCS6422 and capecitabine

Participation Burden

What's physically and logistically required of participants.

Logistics & Travel
In-person visits

Requires travel to a study site

Physical Intervention
Oral

How treatment is administered

Treatment Assignment
Randomized (Open Label)

You are randomly assigned, but you will know your treatment.

Extracted study details

Pulled from the trial record to show what is being tested and what the study is measuring.

Drug classes

capecitabine

Drug routes

oral (Oral Tablet)

Endpoints

Primary: Evaluation of Objective Response Rate (ORR), Number of patients with adverse events (AEs)

Secondary: Evaluation of Disease Control Rate (DCR), Evaluation of Duration of Response (DOR), Evaluation of Progression Free Survival (PFS)

Body systems

Oncology