ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer (NCT07173751)
A Phase III, Multisite, Randomized, Double-Blind Trial of BNT327 in Combination With Chemotherapy Versus Placebo With Chemotherapy in Patients With Previously Untreated Locally Recurrent Inoperable or Metastatic TNBC Determined Ineligible for PD(L)1 Therapy Based on PD-L1 Negative Disease
🩺 Plain-English Summary (8th-Grade Level)
This is a Phase III trial where participants will be randomized to two treatment groups, which means participants will be assigned by equal chance to a treatment group. This trial will be double-blinded, which means neither the participants nor the trial doctors will know which of the two treatments the participants actually receive. Participants will receive either the trial drug with chemotherapy or placebo (which looks like the trial drug but does not have any drug in it) with chemotherapy.
Who can join: Review the eligibility criteria below.
Location: Highlands Oncology Group — Springdale, Arkansas
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (161 Sites)
Showing the first 25 of 161 sites.
- Highlands Oncology Group — Springdale, Arkansas
- University Of California - San Diego Moores Cancer Center — La Jolla, California
- Cedar Sinai - Samuel Oschin Cancer Center — Los Angeles, California
- Stanford University School of Medicine - Stanford Cancer Institute (SCI) - Stanford Women's Cancer Center — Palo Alto, California
- University Of California Davis Health System — Sacramento, California
- Saint John's Health Center - John Wayne Cancer Institute (JWCI) — Santa Monica, California
- Cancer Care Centers of Brevard, Inc — Palm Bay, Florida
- Sacred Heart Medical Oncology Group — Pensacola, Florida
- Cancer Care Specialists — Decatur, Illinois
- Cancer Care Specialists of Illinois — O'Fallon, Illinois
- Carle Foundation Hospital d/b/a Carle Cancer Center — Urbana, Illinois
- University Medical Center, Inc. DBA University of Louisville Hospital/James Graham Brown Cancer Center — Louisville, Kentucky
- New England Cancer Specialists — Westbrook, Maine
- Saint Agnes Hospital, Clinical Research Center — Baltimore, Maryland
- Maryland Oncology Hematology P.A. — Columbia, Maryland
- Lahey Hospital & Medical Center — Burlington, Massachusetts
- Karmanos Cancer Center — Detroit, Michigan
- Profound Research LLC at Michigan Hematology and Oncology Consultants — Royal Oak, Michigan
- Saint Luke's Hospital of Kansas City — Kansas City, Missouri
- Oncology Hematology West, PC dba Nebraska Cancer Specialist — Grand Island, Nebraska
- Paradigm Oncology Hematology West P.C. dba Nebraska Cancer Specialists — Omaha, Nebraska
- Summit Medical Group PA — Florham Park, New Jersey
- Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey) — Livingston, New Jersey
- Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey) — Long Branch, New Jersey
- Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey) — New Brunswick, New Jersey
📞 Contact the Study Coordinator
Phone: (496) 131-9084
Email: patients@biontech.de
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 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.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.