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Study identifier: NCT06568692 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Breast Cancer · TNBC - Triple-Negative Breast Cancer · HER2-negative Breast Cancer  ·  Sponsor: Processa Pharmaceuticals

PhasePhase 2
Planned participants90
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Sian Bigora, PharmD  ·  410-693-6844  ·  sbigora@processapharmaceuticals.com

Always discuss trial participation with your own doctor first.

Locations (13)

Arizona Oncology AssociatesTucson, Arizona, United StatesRecruiting
Valkyrie Clinical TrialsLos Angeles, California, United StatesRecruiting
FOMAT Medical ResearchOxnard, California, United StatesRecruiting
AP Medical ResearchMiami, Florida, United StatesRecruiting
Moffitt Cancer CenterTampa, Florida, United StatesRecruiting
Northwest Cancer CenterDyer, Indiana, United StatesRecruiting
University of Maryland Medical Center (UMMC)Baltimore, Maryland, United StatesRecruiting
Rutgers Cancer Institute of New JerseyNew Brunswick, New Jersey, United StatesRecruiting
Clinical Research AllianceWestbury, New York, United StatesRecruiting
Gabrail Cancer Center ResearchCanton, Ohio, United StatesRecruiting
SCRI Oncology PartnersNashville, Tennessee, United StatesRecruiting
Texas Oncology PA (Austin)Austin, Texas, United StatesRecruiting

+ 1 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06568692