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RECRUITING Phase 3

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

NCT07173751 · View on ClinicalTrials.gov ↗

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

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

123 total trials

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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 558 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BioNTech SE, which has 123 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07173751 reports 14 study locations spanning 12 distinct geographic areas — top geographies include Illinois, Texas, Arkansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07173751?

This trial is sponsored by BioNTech SE, which has 123 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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