๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-06-18

A Phase 2 Study of PCS6422 With Capecitabine in Patients With Advanced or Metastatic Breast Cancer (NCT06568692)

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

๐ŸŸข Recruiting Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Processa Pharmaceuticals

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Arizona Oncology Associates โ€” Tucson, Arizona

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (13 Sites)

  • Arizona Oncology Associates โ€” Tucson, Arizona
  • Valkyrie Clinical Trials โ€” Los Angeles, California
  • FOMAT Medical Research โ€” Oxnard, California
  • AP Medical Research โ€” Miami, Florida
  • Moffitt Cancer Center โ€” Tampa, Florida
  • Northwest Cancer Center โ€” Dyer, Indiana
  • University of Maryland Medical Center (UMMC) โ€” Baltimore, Maryland
  • Rutgers Cancer Institute of New Jersey โ€” New Brunswick, New Jersey
  • Clinical Research Alliance โ€” Westbury, New York
  • Gabrail Cancer Center Research โ€” Canton, Ohio
  • SCRI Oncology Partners โ€” Nashville, Tennessee
  • Texas Oncology PA (Austin) โ€” Austin, Texas
  • Texas Oncology PA (San Antonio) โ€” San Antonio, Texas

๐Ÿ“ž Contact the Study Coordinator

Phone: (410) 693-6844

Email: sbigora@processapharmaceuticals.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Breast Cancer clinical trials

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—