PCS6422 + Capecitabine for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Do I need to stop my current medications to join the trial?
The trial requires that you stop any hormone replacement therapy at least 21 days before joining. If you've had any treatment for advanced or metastatic breast cancer, you must wait 21 days or 5 half-lives (whichever is longer) before joining. Other specific medications like IV 5-FU, oral 5-FU analogs, and DPD inhibitors must be stopped 4 weeks before starting the trial.
Is the combination of PCS6422 and Capecitabine safe for humans?
What makes the drug PCS6422 + Capecitabine unique for breast cancer treatment?
What data supports the effectiveness of the drug PCS6422 + Capecitabine for breast cancer?
Are You a Good Fit for This Trial?
This trial is for individuals with advanced or metastatic breast cancer who can't have treatments like anthracyclines, taxanes, PD-1 or PARP inhibitors. Participants should be able to take oral medication and have acceptable blood test results.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive PCS6422 with Capecitabine or Capecitabine alone over 7 days per cycle
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension (optional)
Participants may opt into continuation of treatment long-term
What Are the Treatments Tested in This Trial?
Interventions
- Capecitabine
- PCS6422
Capecitabine is already approved in European Union, United States, Canada, Japan for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Processa Pharmaceuticals
Lead Sponsor