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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07173751
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 558 participants
Conditions and interventions
Conditions
Interventions
- Pumitamig Drug
- Nab-paclitaxel/Paclitaxel Drug
- Gemcitabine Drug
- Carboplatin Drug
- Eribulin Drug
- Matching placebo 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
- Aug 2, 2026
2025 – 2030
United States locations
- U.S. sites
- 64
- U.S. states
- 20
- U.S. cities
- 52
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Highlands Oncology Group | Springdale | Arkansas | 72762 | Recruiting |
| University Of California - San Diego Moores Cancer Center | La Jolla | California | 92037 | Recruiting |
| Cedar Sinai - Samuel Oschin Cancer Center | Los Angeles | California | 90048 | Recruiting |
| Stanford University School of Medicine - Stanford Cancer Institute (SCI) - Stanford Women's Cancer Center | Palo Alto | California | 94304-2201 | Recruiting |
| University Of California Davis Health System | Sacramento | California | 95817-2229 | Recruiting |
| Saint John's Health Center - John Wayne Cancer Institute (JWCI) | Santa Monica | California | 90404-2312 | Recruiting |
| Cancer Care Centers of Brevard, Inc | Palm Bay | Florida | 32901 | Recruiting |
| Sacred Heart Medical Oncology Group | Pensacola | Florida | 32504 | 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 |
| University Medical Center, Inc. DBA University of Louisville Hospital/James Graham Brown Cancer Center | Louisville | Kentucky | 40202 | Recruiting |
| New England Cancer Specialists | Westbrook | Maine | 04092 | Recruiting |
| Saint Agnes Hospital, Clinical Research Center | Baltimore | Maryland | 21229 | Recruiting |
| Maryland Oncology Hematology P.A. | Columbia | Maryland | 21044 | 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 |
| Saint Luke's Hospital of Kansas City | Kansas City | Missouri | 64111 | 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 |
| Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey) | Livingston | New Jersey | 07039 | Recruiting |
| Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey) | Long Branch | New Jersey | 07740 | Recruiting |
| Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey) | New Brunswick | New Jersey | 08901 | Recruiting |
| Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey) | Newark | New Jersey | 07112 | Recruiting |
| Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey) | Somerville | New Jersey | 08876 | Recruiting |
| Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey) | Toms River | New Jersey | 08755 | Recruiting |
| Paradigm New York Cancer and Blood Specialists | Bay Shore | New York | 11706 | Recruiting |
| Paradigm New York Cancer and Blood Specialists | New York | New York | 10028 | Recruiting |
| Paradigm New York Cancer and Blood Specialists | New York | New York | 10469 | Recruiting |
| Paradigm New York Cancer and Blood Specialists | New York | New York | 11042 | Recruiting |
| Paradigm New York Cancer and Blood Specialists | New York | New York | 11210 | Recruiting |
| Paradigm New York Cancer and Blood Specialists | New York | New York | 11702 | Recruiting |
| Paradigm New York Cancer and Blood Specialists | New York | New York | 11772 | Recruiting |
| Paradigm New York Cancer and Blood Specialists | New York | New York | 11776 | Recruiting |
| Paradigm New York Cancer and Blood Specialists | New York | New York | 11901 | 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 |
| Oncology Specialists of Charlotte Pa | Charlotte | North Carolina | 28204 | Recruiting |
| Carolina Oncology Specialists | Charlotte | North Carolina | 28210 | Recruiting |
| St Charles Bend Cancer Center | Bend | Oregon | 97701 | Recruiting |
| St. Charles Cancer Center - Redmond | Redmond | Oregon | 97756 | Recruiting |
| Oregon Oncology Specialists | Salem | Oregon | 97301 | Recruiting |
| The West Clinic, P.C. dba West Cancer Center | Germantown | Tennessee | 38002 | Recruiting |
| Tennessee Oncology | Nashville | Tennessee | 37203 | Recruiting |
| OneR The Center For Cancer And Blood Disorders (Texas Cancer Care) | Arlington | Texas | 76104 | Recruiting |
| OneR The Center For Cancer And Blood Disorders (Texas Cancer Care) | Burleson | Texas | 76028 | Recruiting |
| UT Southwestern Medical Center at Redbird | Dallas | Texas | 75237 | Recruiting |
| University Of Texas Southwestern Medical Center | Dallas | Texas | 75390 | Recruiting |
| JPS Health Network - Trinity Springs Pavilion | Fort Worth | Texas | 76104 | Recruiting |
| OneR The Center For Cancer And Blood Disorders (Texas Cancer Care) | Fort Worth | Texas | 76104 | Recruiting |
| UT Southwestern Moncrief Cancer Institute | Fort Worth | Texas | 76104 | Recruiting |
| Oncology Consultants PA | Houston | Texas | 77024 | Recruiting |
| Oncology Consultants PA | Houston | Texas | 77030 | Recruiting |
| UT Southwestern Medical Center at Richardson/Plano | Richardson | Texas | 75080 | Recruiting |
| Renovatio Clinical - The Woodlands Research Center | The Woodlands | Texas | 77380 | Recruiting |
| OneR The Center For Cancer And Blood Disorders (Texas Cancer Care) | Weatherford | Texas | 76068 | Recruiting |
| Bon Secours Cancer Institute at Memorial Regional | Mechanicsville | Virginia | 23116 | Recruiting |
| Bon Secours St. Francis Medical Center | Midlothian | Virginia | 23114 | Recruiting |
| Bon Secours Cancer Institute at St. Mary's | Richmond | Virginia | 23226 | Recruiting |
| Northwest Medical Specialties, PLLC | Tacoma | Washington | 98405 | Recruiting |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | 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 97 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 Aug 2, 2026 · Synced Sep 3, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07173751 live on ClinicalTrials.gov.