Phase 2 Study of PCS6422 with Capecitabine for Advanced Breast Cancer

This study is testing an experimental drug called PCS6422 alongside a common chemotherapy drug, capecitabine, for people with advanced or metastatic breast cancer. Researchers want to see if PCS6422, when combined with capecitabine, can make your immune system more active against cancer. This trial is for adults aged 18 and older who have breast cancer that cannot be removed by surgery, including triple-negative breast cancer (TNBC) and HER2-negative breast cancer. You might be eligible if you can't use certain other treatments. The main goals are to see how many people respond to the treatment (Objective Response Rate) and to track any side effects. The study aims to enroll 90 participants, but its current status is unclear.

Study design
This is a Phase 2, open-label (meaning you and your doctors will know which treatment you are receiving), randomized study comparing PCS6422 plus capecitabine to capecitabine alone. It involves multiple centers and plans to enroll 90 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will evaluate how many patients respond to treatment for up to 24 weeks after the end of treatment. Adverse events (side effects) will be monitored during treatment, for an average of 8 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06568692

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Processa Pharmaceuticals
~90 participants
Updated 2025-06-19 on ClinicalTrials.gov
What's tested:PCS6422 and capecitabineCapecitabine

At a glance

Recruiting sites
13 of 13 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Evaluation of Objective Response Rate (ORR)
Measured over Up to 24 weeks post End of Treatment (EoT)
+1 more outcome measured
Breast Cancer
TNBC - Triple-Negative Breast Cancer
HER2-negative Breast Cancer
13 sites across 10 states
California2
Florida2
Texas2
Arizona1
Indiana1
Maryland1
New Jersey1
New York1

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

Class II per the New York Heart Association, or history of myocarditis 7. Is pregnant or breastfeeding
  • Evaluation of Objective Response Rate (ORR)Up to 24 weeks post End of Treatment (EoT)

    The proportion of patients who achieved a confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)

  • Number of patients with adverse events (AEs)During treatment, an average of 8 months

    Frequency, duration, and severity of AEs across treatment groups