ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
Pumitamig: Solution for intravenous (IV) infusion
Nab-paclitaxel/Paclitaxel: IV infusion
Gemcitabine: IV infusion
Carboplatin: IV infusion
Eribulin: IV infusion
Matching placebo: IV infusion
Study summary
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.
Eligibility
Primary outcome measure(s)
- Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) — Up to approximately 32 months
PFS is defined as the time from randomization to first documented tumor progression (progressive disease assessed by BICR per response evaluation criteria in solid tumors \[RECIST\] v1.1), or death from any cause, whichever occurs first. - Overall Survival (OS) — Up to approximately 49 months
OS is defined as the time from randomization to death from any cause.
Trial sites (202)
| Facility | City | Region | Status |
|---|---|---|---|
| Highlands Oncology Group | Springdale | Arkansas | Recruiting |
| University Of California - San Diego Moores Cancer Center | La Jolla | California | Recruiting |
| Cancer and Blood Specialty Clinic (CBSC) | Los Alamitos | California | Recruiting |
| Cedar Sinai - Samuel Oschin Cancer Center | Los Angeles | California | Recruiting |
| Stanford University School of Medicine - Stanford Cancer Institute (SCI) - Stanford Women's Cancer Center | Palo Alto | California | Recruiting |
| University Of California Davis Health System | Sacramento | California | Recruiting |
| Sansum Clinic | Santa Barbara | California | Recruiting |
| Saint John's Health Center - John Wayne Cancer Institute (JWCI) | Santa Monica | California | Recruiting |
| Florida Cancer Specialists | Fort Myers | Florida | Recruiting |
| Cancer Care Centers of Brevard, Inc | Palm Bay | Florida | Recruiting |
| Sacred Heart Medical Oncology Group | Pensacola | Florida | Recruiting |
| Florida Cancer Specialists North | St. Petersburg | Florida | Recruiting |
| Cancer Care Specialists | Decatur | Illinois | Recruiting |
| Cancer Care Specialists of Illinois | O'Fallon | Illinois | Recruiting |
| Carle Foundation Hospital d/b/a Carle Cancer Center | Urbana | Illinois | Recruiting |
| University Medical Center, Inc. DBA University of Louisville Hospital/James Graham Brown Cancer Center | Louisville | Kentucky | Recruiting |
| New England Cancer Specialists | Westbrook | Maine | Recruiting |
| Saint Agnes Hospital, Clinical Research Center | Baltimore | Maryland | Recruiting |
| Maryland Oncology Hematology P.A. | Columbia | Maryland | Recruiting |
| Lahey Hospital & Medical Center | Burlington | Massachusetts | Recruiting |
| Karmanos Cancer Center | Detroit | Michigan | Recruiting |
| Profound Research LLC at Michigan Hematology and Oncology Consultants | Royal Oak | Michigan | Recruiting |
| Healthpartners Regions Specialty Clinics | Saint Louis Park | Minnesota | Recruiting |
| Healthpartners Regions Specialty Clinics | Saint Paul | Minnesota | Recruiting |
| Saint Luke's Hospital of Kansas City | Kansas City | Missouri | Recruiting |
| Oncology Hematology West, PC dba Nebraska Cancer Specialist | Grand Island | Nebraska | Recruiting |
| Paradigm Oncology Hematology West P.C. dba Nebraska Cancer Specialists | Omaha | Nebraska | Recruiting |
| Summit Medical Group PA | Florham Park | New Jersey | Recruiting |
| Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey) | Livingston | New Jersey | Recruiting |
| Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey) | Long Branch | New Jersey | Recruiting |
| Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey) | New Brunswick | New Jersey | Recruiting |
| Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey) | Newark | New Jersey | Recruiting |
| Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey) | Somerville | New Jersey | Recruiting |
| Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey) | Toms River | New Jersey | Recruiting |
| Paradigm New York Cancer and Blood Specialists | Bay Shore | New York | Recruiting |
| Paradigm New York Cancer and Blood Specialists | New York | New York | Recruiting |
| Paradigm New York Cancer and Blood Specialists | New York | New York | Recruiting |
| Paradigm New York Cancer and Blood Specialists | New York | New York | Recruiting |
| Paradigm New York Cancer and Blood Specialists | New York | New York | Recruiting |
| Paradigm New York Cancer and Blood Specialists | New York | New York | Recruiting |
+ 162 more sites — see the full list on the official registry below.
More BioNTech SE trials in Mexico
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07173751 on ClinicalTrials.gov ↗ ← All trials in Mexico