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Terminated Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT06568692

Public ClinicalTrials.gov record NCT06568692. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 22, 2026, 11:57 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 2, Open-Label Study of PCS6422 With Capecitabine in Patients With Advanced or Metastatic Breast Cancer

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT06568692
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 2
Lead sponsor
Processa Pharmaceuticals
Industry
Enrollment
20 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 2, 2024 (Actual)
Primary completion
Jul 29, 2026 (Actual)
Completion
Jul 29, 2026 (Actual)
Last update posted
Oct 6, 2026

2024 – 2026

United States locations

U.S. sites
12
U.S. states
9
U.S. cities
12
Facility City State ZIP Site status
Valkyrie Clinical Trials Los Angeles California 90067 —
FOMAT Medical Research Oxnard California 93030 —
AP Medical Research Miami Florida 33165 —
Moffitt Cancer Center Tampa Florida 33612 —
Northwest Cancer Center Dyer Indiana 46311 —
University of Maryland Medical Center (UMMC) Baltimore Maryland 21201 —
Rutgers Cancer Institute of New Jersey New Brunswick New Jersey 08901 —
Clinical Research Alliance Westbury New York 11590 —
Gabrail Cancer Center Research Canton Ohio 44718 —
SCRI Oncology Partners Nashville Tennessee 37203 —
Texas Oncology PA (Austin) Austin Texas 78731 —
Texas Oncology PA (San Antonio) San Antonio Texas 78240 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06568692, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 6, 2026 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT06568692 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →