Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Phase 3 study of Breast Neoplasms, sponsored by BioNTech SE.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
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
| Field | Value |
|---|---|
| Enrollment Target | 558 participants |
| Start Date | 2025-10-30 |
| Est. Completion | 2030-09 |
| Phase | Phase 3 |
What NCT07173751 shows while recruiting
NCT07173751 is an interventional study that assigns participants to a tested intervention. The registered 558 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 563-participant average among 97 other Breast Neoplasms trials with a reported enrollment target.
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 lists 14 locations in 12 states (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.
Learn More About Clinical Trials
Similar trials for Breast Neoplasms
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07173751's enrollment target sits among peer trials
558 20th of 97 higher than 78 of 97 other Breast Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Neoplasms trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA)
RECRUITING · Phase 3
-
A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032)
RECRUITING · Phase 3
-
Delayed Sentinel Lymph Node Biopsy in Ductal Cancer in Situ
RECRUITING · Phase 3
-
A Study of Sacituzumab Tirumotecan (MK-2870) as a Single Agent and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer (MK-2870-010)
RECRUITING · Phase 3
-
A Clinical Study of Patritumab Deruxtecan to Treat Breast Cancer (MK-1022-016)
RECRUITING · Phase 3
-
A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer
ACTIVE NOT RECRUITING · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05708885 · 557 participants · NA
Striated Esophageal Motor Function Modulation in Health and Disease
- NCT04661358 · 560 participants · Phase 3
Fenofibrate for Prevention of DR Worsening
- NCT05473871 · 560 participants · NA
Enhancing Capacity in Churches to Implement PA Programs
- NCT06001541 · 560 participants · NA
Web-based Program to Improve Self-management Among Veterans-caregiver Dyads
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI