ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer
Public ClinicalTrials.gov record NCT07173751. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Study identification
- NCT ID
- NCT07173751
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- BioNTech SE
- Industry
- Enrollment
- 558 participants
Conditions and interventions
Conditions
Interventions
- Carboplatin Drug
- Eribulin Drug
- Gemcitabine Drug
- Matching placebo Drug
- Nab-paclitaxel/Paclitaxel Drug
- Pumitamig Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 29, 2025
- Primary completion
- Nov 30, 2029
- Completion
- Aug 31, 2030
- Last update posted
- Apr 30, 2026
2025 – 2030
United States locations
- U.S. sites
- 20
- U.S. states
- 13
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Highlands Oncology Group | Springdale | Arkansas | 72762 | Recruiting |
| Stanford University School of Medicine - Stanford Cancer Institute (SCI) - Stanford Women's Cancer Center | Palo Alto | California | 94304-2201 | Recruiting |
| Cancer Care Specialists | Decatur | Illinois | 62526 | Recruiting |
| Cancer Care Specialists of Illinois | O'Fallon | Illinois | 62269 | Recruiting |
| Carle Foundation Hospital d/b/a Carle Cancer Center | Urbana | Illinois | 61801 | Recruiting |
| New England Cancer Specialists | Westbrook | Maine | 04092 | Recruiting |
| Lahey Hospital & Medical Center | Burlington | Massachusetts | 01805 | Recruiting |
| Karmanos Cancer Center | Detroit | Michigan | 48201 | Recruiting |
| Profound Research LLC at Michigan Hematology and Oncology Consultants | Royal Oak | Michigan | 48073 | Recruiting |
| Oncology Hematology West, PC dba Nebraska Cancer Specialist | Grand Island | Nebraska | 68803 | Recruiting |
| Paradigm Oncology Hematology West P.C. dba Nebraska Cancer Specialists | Omaha | Nebraska | 68310 | Recruiting |
| Summit Medical Group PA | Florham Park | New Jersey | 07932 | Recruiting |
| Rochester General Hospital Lipson Cancer Institute | Rochester | New York | 14621 | Recruiting |
| Stony Brook University Medical Center | Stony Brook | New York | 11794 | Recruiting |
| Montefiore Medical Center | The Bronx | New York | 10461 | Recruiting |
| Oregon Oncology Specialists | Salem | Oregon | 97301 | Recruiting |
| The West Clinic, P.C. dba West Cancer Center | Germantown | Tennessee | 38002 | Recruiting |
| Oncology Consultants PA | Houston | Texas | 77024 | Recruiting |
| Oncology Consultants PA | Houston | Texas | 77030 | Recruiting |
| Northwest Medical Specialties, PLLC | Tacoma | Washington | 98405 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 63 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07173751, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 30, 2026 · Synced May 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07173751 live on ClinicalTrials.gov.