Recruiting

Phase 3

Trial Drug with ChemotherapyROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer

Sponsor:

BioNTech SE

Code:

NCT07173751

Conditions

Breast Neoplasms

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pumitamig

Nab-paclitaxel/Paclitaxel

Gemcitabine

Carboplatin

Eribulin

Study Details

Brief 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

Study ID

NCT07173751

Start date

Oct 30, 2025

Status verified date

Jul, 2026

Completion date

Sep, 2030

Anticipated

Primary completion date

Dec, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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 Criteria:

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.

Study Design

Enrollment

558 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm 1: Pumitamig + Treatment of Physician's Choice (TPC) Chemotherapy

Participants will be administered with pumitamig (BNT327) plus chemotherapy regimen.

placebo comparator: Arm 2: Placebo + TPC Chemotherapy

Participants will be administered with matching placebo plus chemotherapy regimen.

Interventions

Pumitamig

Solution for intravenous (IV) infusion

Nab-paclitaxel/Paclitaxel

IV infusion

Gemcitabine

IV infusion

Carboplatin

IV infusion

Eribulin

IV infusion

Matching placebo

IV infusion

Primary outcome measure

Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) [ Time Frame: Up to approximately 32 months ]
Overall Survival (OS) [ Time Frame: Up to approximately 49 months ]

Central Contacts and Locations

Central contacts

BioNTech clinical trials patient information

+49 6131 9084 patients@biontech.de

Locations

Highlands Oncology Group

Recruiting

Springdale, Arkansas, United States, 72762

University Of California - San Diego Moores Cancer Center

Recruiting

La Jolla, California, United States, 92037

Cedar Sinai - Samuel Oschin Cancer Center

Recruiting

Los Angeles, California, United States, 90048

Stanford University School of Medicine - Stanford Cancer Institute (SCI) - Stanford Women's Cancer Center

Recruiting

Palo Alto, California, United States, 94304-2201

University Of California Davis Health System

Recruiting

Sacramento, California, United States, 95817-2229

Saint John's Health Center - John Wayne Cancer Institute (JWCI)

Recruiting

Santa Monica, California, United States, 90404-2312

Cancer Care Centers of Brevard, Inc

Recruiting

Palm Bay, Florida, United States, 32901

Sacred Heart Medical Oncology Group

Recruiting

Pensacola, Florida, United States, 32504

Cancer Care Specialists

Recruiting

Decatur, Illinois, United States, 62526

Cancer Care Specialists of Illinois

Recruiting

O'Fallon, Illinois, United States, 62269

Carle Foundation Hospital d/b/a Carle Cancer Center

Recruiting

Urbana, Illinois, United States, 61801

University Medical Center, Inc. DBA University of Louisville Hospital/James Graham Brown Cancer Center

Recruiting

Louisville, Kentucky, United States, 40202

New England Cancer Specialists

Recruiting

Westbrook, Maine, United States, 04092

Saint Agnes Hospital, Clinical Research Center

Recruiting

Baltimore, Maryland, United States, 21229

Maryland Oncology Hematology P.A.

Recruiting

Columbia, Maryland, United States, 21044

Lahey Hospital & Medical Center

Recruiting

Burlington, Massachusetts, United States, 01805

Karmanos Cancer Center

Recruiting

Detroit, Michigan, United States, 48201

Profound Research LLC at Michigan Hematology and Oncology Consultants

Recruiting

Royal Oak, Michigan, United States, 48073

Saint Luke's Hospital of Kansas City

Recruiting

Kansas City, Missouri, United States, 64111

Oncology Hematology West, PC dba Nebraska Cancer Specialist

Recruiting

Grand Island, Nebraska, United States, 68803

Paradigm Oncology Hematology West P.C. dba Nebraska Cancer Specialists

Recruiting

Omaha, Nebraska, United States, 68310

Summit Medical Group PA

Recruiting

Florham Park, New Jersey, United States, 07932

Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey)

Recruiting

Livingston, New Jersey, United States, 07039

Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey)

Recruiting

Long Branch, New Jersey, United States, 07740

Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey)

Recruiting

New Brunswick, New Jersey, United States, 08901

Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey)

Recruiting

Newark, New Jersey, United States, 07112

Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey)

Recruiting

Somerville, New Jersey, United States, 08876

Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey)

Recruiting

Toms River, New Jersey, United States, 08755