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NCT07173751 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Breast Neoplasms, sponsored by BioNTech SE.

Recruiting
Registry status
Phase 3
Development phase
558
Enrollment target
14
Study locations

NCT07173751 is a Phase 3 study of Breast Neoplasms that is actively recruiting participants, run by BioNTech SE. The registered enrollment target is 558 participants, roughly in line with the 563-participant average among 97 other Breast Neoplasms trials with a reported enrollment target. The trial reports 14 study locations across 12 states.

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The verdict

NCT07173751, a Phase 3 study of Breast Neoplasms, is actively recruiting participants, sponsored by BioNTech SE.

RECRUITING
Registry status
Phase 3
Development phase
558 participants
Enrollment target
14
Study locations

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 Studied

Breast Neoplasms

Interventions

  • DRUG Carboplatin
  • DRUG Pumitamig
  • DRUG Gemcitabine
  • DRUG Eribulin
  • DRUG Nab-paclitaxel/Paclitaxel

Study Locations (14)

Illinois

  • Cancer Care Specialists - Decatur
  • Cancer Care Specialists of Illinois - O'Fallon

Texas

  • Oncology Consultants PA - Houston
  • Oncology Consultants PA - Houston

Arkansas

  • Highlands Oncology Group - Springdale

Maine

  • New England Cancer Specialists - Westbrook

Massachusetts

  • Lahey Hospital & Medical Center - Burlington

Michigan

  • Profound Research LLC at Michigan Hematology and Oncology Consultants - Royal Oak

Oregon

  • Oregon Oncology Specialists - Salem

Tennessee

  • The West Clinic, P.C. dba West Cancer Center - Germantown

Trial Details

FieldValue
Enrollment Target 558 participants
Start Date 2025-10-30
Est. Completion 2030-09
Phase Phase 3

Sponsor

BioNTech SE

53 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07173751

The ClinicalTrials.gov registry entry for NCT07173751 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 558 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 563-participant average among 97 other Breast Neoplasms trials with a reported enrollment target. The listed sponsor is BioNTech SE, which has 53 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Breast Neoplasms appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.

NCT07173751 reports 14 study locations spanning 12 distinct geographic areas - top geographies include Illinois, Texas, Arkansas.

Frequently Asked Questions

What is clinical trial NCT07173751 about?

NCT07173751 is a clinical study titled "ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer". 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...

What is the current status of trial NCT07173751?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 558 participants. The study started on 2025-10-30. Estimated completion is 2030-09.

What conditions does trial NCT07173751 study?

This clinical trial studies the following conditions: Breast Neoplasms.

What interventions are being tested in trial NCT07173751?

The interventions under investigation include: Carboplatin (DRUG), Pumitamig (DRUG), Gemcitabine (DRUG), Eribulin (DRUG), Nab-paclitaxel/Paclitaxel (DRUG).

Who is sponsoring clinical trial NCT07173751?

This trial is sponsored by BioNTech SE, which has 53 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07173751 being conducted?

This trial has 14 study locations across Arkansas, Illinois, Maine, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.