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: 13 countries
• Sites: 104

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 (104)

Highlands Oncology Group

Springdale, Arkansas, 72762, United States

RECRUITING

University Of California - San Diego Moores Cancer Center

La Jolla, California, 92037, United States

RECRUITING

Cedar Sinai - Samuel Oschin Cancer Center

Los Angeles, California, 90048, 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

Sacred Heart Medical Oncology Group

Pensacola, Florida, 32504, 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

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

Louisville, Kentucky, 40202, United States

RECRUITING

New England Cancer Specialists

Westbrook, Maine, 04092, United States

RECRUITING

Saint Agnes Hospital, Clinical Research Center

Baltimore, Maryland, 21229, United States

RECRUITING

Lahey Hospital & Medical Center

Burlington, Massachusetts, 01805, United States

RECRUITING

Karmanos Cancer Center

Detroit, Michigan, 48201, United States

RECRUITING

Profound Research LLC at Michigan Hematology and Oncology Consultants

Royal Oak, Michigan, 48073, United States

RECRUITING

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

RECRUITING

Oncology Hematology West, PC dba Nebraska Cancer Specialist

Grand Island, Nebraska, 68803, United States

RECRUITING

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

Omaha, Nebraska, 68310, United States

RECRUITING

Summit Medical Group PA

Florham Park, New Jersey, 07932, United States

RECRUITING

Rochester General Hospital Lipson Cancer Institute

Rochester, New York, 14621, United States

RECRUITING

Stony Brook University Medical Center

Stony Brook, New York, 11794, 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

St Vincent's Hospital - The Kinghorn Cancer Centre

Darlinghurst, New South Wales, 2010, Australia

RECRUITING

GenesisCare St Andrew's Precinct

Adelaide, South Australia, 50000, Australia

RECRUITING

Peninsula & South Eastern Hematology and Oncology Group

Frankston, Victoria, 3199, Australia

RECRUITING

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

RECRUITING

Monash University - Monash Medical Centre (MMC) - Clayton

Melbourne, Victoria, 3168, Australia

RECRUITING

Westmead Hospital

Westmead, 2145, Australia

RECRUITING

Universitair Ziekenhuis Brussel (AZ-VUB - Academisch Ziekenhuis der Vrije Universiteit Brussel)

Brussels, 1090, Belgium

RECRUITING

Grand hospital de Charleroi

Gilly, 6060, Belgium

RECRUITING

University Hospitals Leuven

Leuven, 3000, Belgium

RECRUITING

Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc

Woluwe-Saint-Lambert, 1200, Belgium

RECRUITING

Changde First People's Hospital

Changde, 415003, China

RECRUITING

Shandong Cancer Hospital And Institute

Jinan, 250117, China

RECRUITING

Fudan University - Shanghai Cancer Center (FUSCC)

Shanghai, 200032, China

RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, 450052, China

RECRUITING

Fakultni nemocnice Motol a Homolka

Prague, 150 06, Czechia

RECRUITING

High Technology Hospital Medcenter LTD

Batumi, 6000, Georgia

RECRUITING

Multiprofile Clinic Consilium Medulla

Tbilisi, 0168, Georgia

RECRUITING

LLC Todua Clinic

Tbilisi, 112, Georgia

RECRUITING

Caucasus Medical Centre

Tbilisi, 186, Georgia

RECRUITING

Hämatologische-Onkologische Praxis Augsburg

Augsburg, 86150, Germany

RECRUITING

Praxis Fuer Interdisziplinaere Onkologie & Haematologie

Freiburg im Breisgau, 79106, Germany

RECRUITING

Institut fuer Versorgungsforschung in der Onkologie

Koblenz, 56068, Germany

RECRUITING

Centro di Riferimento Oncologico (CRO)

Aviano, 33081, Italy

RECRUITING

Azienda Unità Sanitaria Locale 2 (USL2) Lucca

Lucca, 55100, Italy

RECRUITING

Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele)

Milan, 20132, Italy

RECRUITING

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, 20133, Italy

RECRUITING

IRCCS-Istituto Europeo di Oncologia

Milan, 20141, Italy

RECRUITING

Fondazione Policlinico Universitario Campus Bio-Medico

Roma, 00128, Italy

RECRUITING

Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I

Torrette, 60126, Italy

RECRUITING

Chiba Cancer Center

Chiba, 260-8717, Japan

RECRUITING

Fukushima Medical University Hospital

Fukushima, 960-1295, Japan

RECRUITING

Gifu University Hospital

Gifu, 501-1112, Japan

RECRUITING

Hiroshima City Hiroshima Citizens Hospital

Hiroshima, 730-8518, Japan

RECRUITING

Kumamoto University Hospital

Kumamoto, 860-8556, Japan

RECRUITING

Kyoto University Hospital

Kyoto, 606-8507, Japan

RECRUITING

National Hospital Organization Shikoku Cancer Center

Matsuyama, 791-0280, Japan

RECRUITING

Nagoya City University Hospital

Nagoya, 467-8602, Japan

RECRUITING

Tohoku University Hospital

Sendai, 980-8574, Japan

RECRUITING

National Center For Global Health And Medicine

Shinjuku-Ku, 162-8655, Japan

RECRUITING

IP Clinic Sp. z o.o.

Lodz, 90-752, Poland

RECRUITING

Narodowy Insytut Onkologii im. Marii Sklodowskiej-Curie - Państwowy Instytut Badawczy

Warsaw, 02-781, Poland

RECRUITING

Soon Chun Hyang University Cheonan Hospital

Cheonan, 31151, South Korea

RECRUITING

Chungbuk National University Hospital

Cheongju-si, 28644, South Korea

RECRUITING

National Cancer Center

Goyang-si, 10408, South Korea

RECRUITING

Seoul National University Bundang Hospital (SNUBH)

Seongnam-si, 13620, South Korea

RECRUITING

Korea University Anam Hospital

Seoul, 2841, South Korea

RECRUITING

Severance Hospital, Yonsei University Health System

Seoul, 3722, South Korea

RECRUITING

Asan Medical Center (AMC)

Seoul, 5505, South Korea

RECRUITING

Samsung Medical Center

Seoul, 6351, South Korea

RECRUITING

Ajou University Hospital

Suwon, 16499, South Korea

RECRUITING

Hospital Universitario de Badajoz

Badajoz, 6006, Spain

RECRUITING

Parc de Salut Mar - Hospital del Mar

Barcelona, 8003, Spain

RECRUITING

Institut Oncologic Rosell - Hospital General De Catalunya

Barcelona, 8195, Spain

RECRUITING

Hospital Universitario Reina Sofia

Córdoba, 14004, Spain

RECRUITING

IOB Institute of Oncology - Beata Maria Ana Hospital

Madrid, 28007, Spain

RECRUITING

Universidad de Navarra - Clinica Universidad de Navarra (CUN)

Madrid, 28027, Spain

RECRUITING

Hospital Universitario Fundación Jiménez Díaz

Madrid, 28040, Spain

RECRUITING

Hospital Universitario Madrid Sanchinarro - Centro Integral Oncologico Clara Campal (CIOCC)

Madrid, 28050, Spain

RECRUITING

Hospital General Universitario Morales Meseguer

Murcia, 30008, Spain

RECRUITING

Hospital Universitario Virgen De La Arrixaca (Huva)

Murcia, 30120, Spain

RECRUITING

Universidad de Navarra - Clínica Universidad de Navarra (CUN)

Pamplona, 31008, Spain

RECRUITING

Hospital Universitari Parc Tauli

Sabadell, 8208, Spain

RECRUITING

Fundación Instituto Valenciano de Oncología

Valencia, 46009, Spain

RECRUITING

Royal Sussex County Hospital - University Hospitals Sussex NHS Foundation Trust

Brighton, BN2 5BE, United Kingdom

RECRUITING

University Hospitals Bristol and Weston NHS Foundation Trust, Bristol Haematology & Oncology Centre

Bristol, BS2 8ED, United Kingdom

RECRUITING

Hull and East Yorkshire Hospitals NHS Trust - Castle Hill Hospital

Cottingham, HU16 5JQ, United Kingdom

RECRUITING

Edinburgh Cancer Centre-Western General Hospital

Edinburgh, EH4 2LF, United Kingdom

RECRUITING

St James's University Hospital - Leeds Teaching Hospitals NHS Trust

Leeds, LS9 7TF, United Kingdom

RECRUITING

St Bartholomew's Hospital - Barts Health NHS Trust

London, EC1A 7BE, United Kingdom

RECRUITING

University College London Hospitals NHS Foundation Trust

London, NW2 1PG, United Kingdom

RECRUITING

The Royal Free Hospital - Royal Free London NHS Foundation Trust

London, NW3 2QG, United Kingdom

RECRUITING

Sarah Cannon Research Institute

London, W1G 6AD, United Kingdom

RECRUITING

Churchill Hospital - Oxford University Hospitals NHS Foundation Trust

Oxford, OX3 7LE, United Kingdom

RECRUITING

North Wales Cancer Treatment C - Glan Clwyd Hospital

Rhyl, LL18 5UJ, United Kingdom

RECRUITING

Southampton General Hospital - University Hospital Southampton NHS Foundation Trust

Southampton, SO16 6YD, United Kingdom

RECRUITING

Royal Stoke University Hospital - University Hospitals of North Midlands NHS Trust

Stoke-on-Trent, ST4 6QG, 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: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (6); GE (4); CN (4); US (26); KR (9); GB (15); PL (2); IT (7); DE (3); ES (13); BE (4); JP (10); CZ (1)