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RECRUITING Phase 2

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

NCT06568692 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DRUG Capecitabine
  • DRUG PCS6422 and capecitabine

Study Locations (13)

California

  • Valkyrie Clinical Trials — Los Angeles
  • FOMAT Medical Research — Oxnard

Florida

  • AP Medical Research — Miami
  • Moffitt Cancer Center — Tampa

Texas

  • Texas Oncology PA (Austin) — Austin
  • Texas Oncology PA (San Antonio) — San Antonio

Arizona

  • Arizona Oncology Associates — Tucson

Indiana

  • Northwest Cancer Center — Dyer

Maryland

  • University of Maryland Medical Center (UMMC) — Baltimore

New Jersey

  • Rutgers Cancer Institute of New Jersey — New Brunswick

New York

  • Clinical Research Alliance — Westbury

Trial Details

FieldValue
Enrollment Target 90 participants
Start Date 2024-10-02
Est. Completion 2026-10
Phase Phase 2

Sponsor

Processa Pharmaceuticals

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06568692

The ClinicalTrials.gov registry entry for NCT06568692 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Processa Pharmaceuticals, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions — of which Capecitabine is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06568692 reports 13 study locations spanning 10 distinct geographic areas — top geographies include California, Florida, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06568692 about?

NCT06568692 is a clinical study titled "A Phase 2 Study of PCS6422 With Capecitabine in Patients With Advanced or Metastatic Breast Cancer". 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 ...

What is the current status of trial NCT06568692?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 90 participants. The study started on 2024-10-02. Estimated completion is 2026-10.

What conditions does trial NCT06568692 study?

This clinical trial studies the following conditions: Breast Cancer, HER2-negative Breast Cancer, TNBC - Triple-Negative Breast Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06568692?

The interventions under investigation include: Capecitabine (DRUG), PCS6422 and capecitabine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06568692?

This trial is sponsored by Processa Pharmaceuticals, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06568692 being conducted?

This trial has 13 study locations across Arizona, California, Florida, Indiana, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial