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ROSETTA Breast-01: Pumitamig for Triple-Negative Breast Cancer

This study is looking at the effects and safety of a drug called pumitamig for people with triple-negative breast cancer (TNBC) that has come back or spread, or a specific type of HER2-negative breast cancer. You might be able to join if you are not eligible for certain immunotherapy treatments based on your tumor's PD-L1 status. Participants will receive either pumitamig with chemotherapy (nab-paclitaxel/paclitaxel, gemcitabine, carboplatin, or eribulin) or a placebo (an inactive substance) with chemotherapy. Researchers will measure how long people live without their cancer growing (Progression-Free Survival) and how long they live overall (Overall Survival) to see if the treatment is successful. The study plans to enroll 558 participants.

Study design
This is a Phase III, double-blinded study where participants will be randomly assigned to one of two treatment groups. Neither you nor your doctors will know which treatment you are receiving.
What's involved
You will have a screening period of up to 28 days, followed by a treatment period until your disease progresses or you experience intolerable side effects. There will also be safety and survival follow-up periods.
Compensation
Not stated in the trial record.
Follow-up
You will have a safety follow-up for up to 90 days after your last treatment dose, and a survival follow-up for up to approximately 49 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07173751

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
BioNTech SE
~558 participants
Updated 2026-08-03 on ClinicalTrials.gov
What's tested:PumitamigNab-paclitaxel/PaclitaxelGemcitabineCarboplatinEribulinMatching placebo

At a glance

Recruiting sites
161 of 161 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)
Measured over Up to approximately 32 months
+1 more outcome measured

Conditions

Breast Neoplasms

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Where it's being run

161 sites across 36 states
United Kingdom15
Spain13
New York12
Texas12
Japan12
South Korea9
Italy8
New Jersey7

Study leadership

  • BioNTech Responsible Person · STUDY_DIRECTOR · BioNTech SE

Who to contact

BioNTech clinical trials patient information
[email protected]
+49 6131 9084 · ext. 0
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

Are considered ineligible for combination treatment with a monospecific PD(L)1 targeting immunotherapy plus chemotherapy as per their tumor PD-L1 expression status.
Have confirmed locally recurrent inoperable or metastatic TNBC, or estrogen receptor (ER)-low, human epidermal growth factor receptor 2 (HER2)-negative breast cancer (ER and/or progesterone receptor \[PgR\]) 1% to 10%, HER2 immunohistochemistry \[IHC\] 0, 1+, or 2+ with fluorescence in situ hybridization \[FISH\] negative for HER2 gene amplification) documented prior to trial screening as part of standard of care.
Have at least one measurable lesion as the targeted lesion based on RECIST v1.1.
Have provided a tissue sample, archival or fresh, during the screening period (bone biopsies, fine needle aspiration biopsies, and samples from pleural or peritoneal fluid are not acceptable; participants with only one target lesion are not eligible to participate in the trial).
Eastern cooperative oncology group (ECOG) performance status of 0 or 1.

Exclusion

Have received any of the following therapies or drugs prior to the initiation of trial:
Have received prior systemic anticancer therapy for advanced disease.
Have received prior treatment with a PD(L)-1/vascular endothelial growth factor (VEGF) bispecific antibody.
Have received systemic corticosteroids (at a dosage greater than 10 milligrams \[mg\]/day of prednisone or an equivalent dose of other corticosteroids) within 7 days prior to the initiation of trial treatment. Exception: excluding local, intranasal, intraocular, intra-articular or inhaled corticosteroids, short-term use (\<= 7 days) of corticosteroids for prophylaxis (for example, prevention of contrast agent allergy) or treatment of non-autoimmune conditions (for example, delayed hypersensitivity reactions caused by exposure to allergens).
Have been vaccinated with live attenuated vaccine(s) within 4 weeks prior to initiation of trial treatment.
Have received broad-spectrum intravenous antibiotics therapy within 2 weeks prior to initiation of trial treatment.
Are pregnant or breastfeeding or are planning pregnancy or planning to father children during the trial or within 6 months after the last dose of pumitamig or placebo.
Have undergone major organ surgery, significant trauma, or invasive dental procedures (such as dental implants) within 28 days prior to the initiation of trial treatment or plan to undergo elective surgery during the trial. Placement of vascular infusion devices is allowed.
Have received allogeneic hematopoietic stem cell transplantation or organ transplantation.

What this trial measures

  • Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)Up to approximately 32 months

    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.

  • Overall Survival (OS)Up to approximately 49 months

    OS is defined as the time from randomization to death from any cause.