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ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer

NCT07173751 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 558

Last updated 2026-05-22

No results posted yet for this 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.

Conditions

  • Breast Neoplasms

Interventions

DRUG

Pumitamig

Solution for intravenous (IV) infusion

DRUG

Nab-paclitaxel/Paclitaxel

IV infusion

DRUG

Gemcitabine

IV infusion

DRUG

Carboplatin

IV infusion

DRUG

Eribulin

IV infusion

DRUG

Matching placebo

IV infusion

Sponsors & Collaborators

Principal Investigators

  • BioNTech Responsible Person · BioNTech SE

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-30
Primary Completion
2029-12-31
Completion
2030-09-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • China
  • Czechia
  • Georgia
  • Germany
  • Italy
  • Japan
  • Poland
  • South Korea
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07173751 on ClinicalTrials.gov