OncoMatch/Clinical Trials/NCT07173751
ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer
Is NCT07173751 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments for breast neoplasms.
Treatment: Pumitamig · Nab-paclitaxel/Paclitaxel · Gemcitabine · Carboplatin · Eribulin — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) negative (IHC 0, 1+, or 2+ with FISH negative for HER2 gene amplification) (IHC 0, 1+, or 2+ with FISH negative)
HER2-negative breast cancer (HER2 immunohistochemistry [IHC] 0, 1+, or 2+ with fluorescence in situ hybridization [FISH] negative for HER2 gene amplification)
Allowed: ESR1 low expression (1%-10%)
estrogen receptor (ER)-low ... (ER and/or progesterone receptor [PgR] 1% to 10%)
Allowed: PR (PGR) low expression (1%-10%)
progesterone receptor [PgR] 1% to 10%
Disease stage
Metastatic disease required
locally recurrent inoperable or metastatic TNBC, or ER-low, HER2-negative breast cancer
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic anticancer therapy
Have received prior systemic anticancer therapy for advanced disease
Cannot have received: PD(L)-1/VEGF bispecific antibody
Have received prior treatment with a PD(L)-1/vascular endothelial growth factor (VEGF) bispecific antibody
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Highlands Oncology Group · Springdale, Arkansas
- Stanford University School of Medicine - Stanford Cancer Institute (SCI) - Stanford Women's Cancer Center · Palo Alto, California
- Cancer Care Specialists · Decatur, Illinois
- Cancer Care Specialists of Illinois · O'Fallon, Illinois
- Carle Foundation Hospital d/b/a Carle Cancer Center · Urbana, Illinois
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify