Phase 2 Study of PCS6422 Combined with Capecitabine for Advanced or Metastatic Breast Cancer Not Treatable with Certain Therapies

What this Trial Is About

Researchers are evaluating the combination of PCS6422 with capecitabine compared to capecitabine alone in patients with advanced or metastatic breast cancer who cannot use anthracycline-, taxane-based, or other available therapies such as PD-1 or PARP inhibitors. This adaptive Phase 2, open-label, randomized, multi-center study aims to assess the efficacy and safety of adding PCS6422 to capecitabine in this patient population who have already received chemotherapy in the metastatic setting. Participants are randomly assigned to one of three groups two different dosing regimens of PCS6422 combined with capecitabine or the standard dose of capecitabine alone. PCS6422 is given as a fixed single dose alongside capecitabine administered twice daily over seven days, with capecitabine doses varying between study arms from 150 mg to 450 mg twice daily. The study includes a treatment period followed by assessments up to 24 weeks after the end of treatment. During the study, participants will have regular imaging to measure tumor response according to RECIST 1.1 criteria, laboratory tests to monitor blood counts and organ function, and evaluations of adverse events over an average of eight months of treatment. Researchers will track outcomes such as objective response rate, disease control rate, duration and time to response, and progression-free survival. The trial involves ongoing safety monitoring and assessments throughout the treatment and follow-up periods.

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