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

NCT07173751 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: BNT327-052025-521884-12-00
• Study Type: interventional
• Target: 558
• Locations: 6 countries
• Sites: 28

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

Keywords

Metastatic TNBC; Bispecific antibody; Programmed death-ligand 1 (PD-L1); Immunotherapy; Immunotherapy in combination with chemotherapy; Combination with other investigational agents

Outcome Measures

Primary Outcomes (2)

• Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)

  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.

  Up to approximately 32 months

• Overall Survival (OS)

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

  Up to approximately 49 months

Secondary Outcomes (15)

• Objective Response Rate (ORR) as Assessed by BICR

  Up to approximately 49 months

• PFS

  Up to approximately 32 months

• ORR

  Up to approximately 49 months

• Duration of Response (DOR)

  Up to approximately 49 months

• Disease Control Rate (DCR)

  Up to approximately 32 months

Study Arms (2)

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

EXPERIMENTAL

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

Drug: Pumitamig; Drug: Nab-paclitaxel/Paclitaxel; Drug: Gemcitabine; Drug: Carboplatin; Drug: Eribulin

Arm 2: Placebo + TPC Chemotherapy

PLACEBO COMPARATOR

Participants will be administered with matching placebo plus chemotherapy regimen.

Drug: Nab-paclitaxel/Paclitaxel; Drug: Gemcitabine; Drug: Carboplatin; Drug: Eribulin; Drug: Matching placebo

Interventions

Pumitamig DRUG

Solution for intravenous (IV) infusion

Also known as: BNT327, PM8002, BMS-986545

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

Nab-paclitaxel/Paclitaxel DRUG

IV infusion

Arm 1: Pumitamig + Treatment of Physician's Choice (TPC) Chemotherapy; Arm 2: Placebo + TPC Chemotherapy

Gemcitabine DRUG

IV infusion

Arm 1: Pumitamig + Treatment of Physician's Choice (TPC) Chemotherapy; Arm 2: Placebo + TPC Chemotherapy

Carboplatin DRUG

IV infusion

Arm 1: Pumitamig + Treatment of Physician's Choice (TPC) Chemotherapy; Arm 2: Placebo + TPC Chemotherapy

Eribulin DRUG

IV infusion

Arm 1: Pumitamig + Treatment of Physician's Choice (TPC) Chemotherapy; Arm 2: Placebo + TPC Chemotherapy

Matching placebo DRUG

IV infusion

Arm 2: Placebo + TPC Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• BioNTech SE: lead
• Bristol-Myers Squibb: collaborator

Study Sites (28)

Highlands Oncology Group

Springdale, Arkansas, 72762, United States

RECRUITING

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

Palo Alto, California, 94304-2201, United States

RECRUITING

Cancer Care Specialists

Decatur, Illinois, 62526, United States

RECRUITING

Cancer Care Specialists of Illinois

O'Fallon, Illinois, 62269, United States

RECRUITING

Carle Foundation Hospital d/b/a Carle Cancer Center

Urbana, Illinois, 61801, United States

RECRUITING

New England Cancer Specialists

Westbrook, Maine, 04092, United States

RECRUITING

Lahey Hospital & Medical Center

Burlington, Massachusetts, 01805, United States

RECRUITING

Profound Research LLC at Michigan Hematology and Oncology Consultants

Royal Oak, Michigan, 48073, United States

RECRUITING

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

Omaha, Nebraska, 68310, United States

RECRUITING

Montefiore Medical Center

The Bronx, New York, 10461, United States

RECRUITING

Oregon Oncology Specialists

Salem, Oregon, 97301, United States

RECRUITING

The West Clinic, P.C. dba West Cancer Center

Germantown, Tennessee, 38002, United States

RECRUITING

Oncology Consultants PA

Houston, Texas, 77024, United States

RECRUITING

Oncology Consultants PA

Houston, Texas, 77030, United States

RECRUITING

Northwest Medical Specialties, PLLC

Tacoma, Washington, 98405, United States

RECRUITING

GenesisCare St Andrew's Precinct

Adelaide, South Australia, 50000, Australia

RECRUITING

Peninsula & South Eastern Hematology and Oncology Group

Frankston, Victoria, 3199, Australia

RECRUITING

Fudan University - Shanghai Cancer Center (FUSCC)

Shanghai, 200032, China

RECRUITING

High Technology Hospital Medcenter LTD

Batumi, 6000, Georgia

RECRUITING

LLC Todua Clinic

Tbilisi, 112, Georgia

RECRUITING

Caucasus Medical Centre

Tbilisi, 186, Georgia

RECRUITING

Chungbuk National University Hospital

Cheongju-si, 28644, South Korea

RECRUITING

Korea University Anam Hospital

Seoul, 2841, South Korea

RECRUITING

Severance Hospital, Yonsei University Health System

Seoul, 3722, South Korea

RECRUITING

Edinburgh Cancer Centre-Western General Hospital

Edinburgh, EH4 2LF, United Kingdom

RECRUITING

Sarah Cannon Research Institute

London, W1G 6AD, United Kingdom

RECRUITING

Torbay Hosptial, South Devon Healthcare NHS Foundation Trust

Torquay, TQ2 7AA, United Kingdom

RECRUITING

New Cross Hospital - The Royal Wolverhampton NHS Trust

Wolverhampton, WV10 0QP, United Kingdom

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

130-nm albumin-bound paclitaxel; Gemcitabine; Carboplatin; eribulin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals

Study Officials

• BioNTech Responsible Person

  BioNTech SE

  STUDY DIRECTOR

Central Study Contacts

BioNTech clinical trials patient information

CONTACT

+49 6131 9084; patients@biontech.de

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: September 15, 2025
• Study Start: October 30, 2025
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): September 1, 2030
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2); GE (3); CN (1); US (15); KR (3); GB (4)