🏛️ Verified NIH Record • Updated 2026-06-29

Safety and Preliminary Effectiveness of BNT327, an Investigational Therapy for Breast Cancer, When Given in Combination With Chemotherapy (NCT06449222)

A Phase II, Multi-site, Randomized, Open-label Clinical Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of BNT327 at Two Dose Levels in Combination With Chemotherapeutic Agents as First- and Second-line Treatment in Triple-negative Breast Cancer

🔵 Active, Not Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: BioNTech SE

🩺 Plain-English Summary (8th-Grade Level)

This study is a Phase II, multi-site, randomized, open-label clinical study to evaluate the safety, efficacy, and pharmacokinetics (PK) of BNT327 at two dose levels in combination with chemotherapeutic agents in the first- and second-line treatment of participants with locally advanced/metastatic triple-negative breast cancer (mTNBC).

Who can join: Review the eligibility criteria below.

Location: Beverly Hills Cancer Center — Beverly Hills, California

Age range: 18 Years

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (31 Sites)

Showing the first 25 of 31 sites.

  • Beverly Hills Cancer Center — Beverly Hills, California
  • Valkyrie Clinical Trials — Los Angeles, California
  • Stanford University School of Medicine - Stanford Cancer Institute (SCI) - Stanford Women's Cancer Center — Palo Alto, California
  • Saint John's Health Center - John Wayne Cancer Institute (JWCI) — Santa Monica, California
  • Rocky Mountain Cancer Centers (RMCC) — Denver, Colorado
  • Yale University - Yale Cancer Center — New Haven, Connecticut
  • Carle Foundation Hospital d/b/a Carle Cancer Center — Urbana, Illinois
  • HealthPartners Regions Specialty Clinics — Saint Louis Park, Minnesota
  • Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey) — New Brunswick, New Jersey
  • Stony Brook University Hospital — Stony Brook, New York
  • The West Clinic, P.C. d/b/a West Cancer Center — Germantown, Tennessee
  • SCRI Oncology Partners — Nashville, Tennessee
  • Bon Secours St. Francis Medical Center — Midlothian, Virginia
  • Peninsula Oncology Centre — Frankston,
  • Peter MacCallum Cancer Centre — Melbourne,
  • Baskent Universitesi Tip Fakultesi Adana Hastanesi — Adana,
  • Medical Park Seyhan Hospital — Adana,
  • Sakarya University - Faculty of Medicine — Adapazarı,
  • Hacettepe Universitesi Kanser Enstitusu — Ankara,
  • Sbu Dr.A.Y. Ankara Onkoloji SUAM — Ankara,
  • Memorial Ankara Hospital — Ankara,
  • Koc Universitesi Hastanesi (Koc University Hospital) — Istanbul,
  • Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi — Istanbul,
  • Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi — Istanbul,
  • Yeditepe University Hospital — Istanbul,

💰 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 § 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.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  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.
🏛️ View Official NIH Record ↗