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NCT06568692 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Breast Cancer and HER2-Negative Breast Cancer, sponsored by Processa Pharmaceuticals.

Recruiting
Registry status
Phase 2
Development phase
90
Enrollment target
13
Study locations

NCT06568692 is a Phase 2 study of Breast Cancer and HER2-Negative Breast Cancer that is actively recruiting participants, run by Processa Pharmaceuticals. The registered enrollment target is 90 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (97% lower). The trial reports 13 study locations across 10 states.

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The verdict

NCT06568692, a Phase 2 study of Breast Cancer and HER2-Negative Breast Cancer, is actively recruiting participants, sponsored by Processa Pharmaceuticals.

RECRUITING
Registry status
Phase 2
Development phase
90 participants
Enrollment target
13
Study locations

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.

Conditions Studied

Breast Cancer HER2-Negative Breast Cancer TNBC - Triple-Negative Breast Cancer

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

9 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, categorized as Phase 2. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (97% lower). The listed sponsor is Processa Pharmaceuticals, which has 9 total studies on file at ClinicalTrials.gov.

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.

NCT06568692 reports 13 study locations spanning 10 distinct geographic areas - top geographies include California, Florida, Texas.

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.

What interventions are being tested in trial NCT06568692?

The interventions under investigation include: Capecitabine (DRUG), PCS6422 and capecitabine (DRUG).

Who is sponsoring clinical trial NCT06568692?

This trial is sponsored by Processa Pharmaceuticals, which has 9 total clinical trials registered on ClinicalTrials.gov.

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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.