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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: Recruiting Phase 2 study of Breast Cancer and HER2-Negative Breast Cancer, sponsored by Processa Pharmaceuticals.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The proportion of patients who achieved a confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2024-10-02 |
| Est. Completion | 2026-10 |
| Phase | Phase 2 |
What NCT06568692 shows while recruiting
NCT06568692 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (97% lower).
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 lists 13 locations in 10 states (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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06568692's enrollment target sits among peer trials
90 613th of 1224 higher than 604 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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