A Phase 2 Study of PCS6422 With Capecitabine in Patients With Advanced or Metastatic Breast Cancer
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Aged ≥18 years at Screening 2. Diagnosis of histologically confirmed breast cancer that is unresectable. The following subsets of breast cancer are included: 1. Patients with triple-negative breast cancer, advanced or metastatic 2. Patients with hormone receptor (HR) positive, ER positive, HER2 negative advanced or metastatic breast cancer 3. Has measurable disease in accordance with RECIST 1.1 obtained by imaging within 28 days prior to C1D1 4. Other therapies are not indicated (eg, resistant or intolerant to taxanes and/or an anthracycline-containing regimen) for treatment of advanced or metastatic breast cancer 5. Has a life expectance of at least 24 weeks 6. Has Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1 at screening 7. Has adequate bone marrow, liver, and renal function as assessed by the following laboratory requirements conducted within 7 days before C1D1 (Note: labs will also be repeated pre-dose on C1D1 to confirm eligibility)