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NCT07173751PHASE3Recruiting

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

BioNTech SE

Start Date

10/30/2025

Completion Date

9/1/2030

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.

Detailed Description

The study consists of a: 1. Screening period (up to 28 days); 2. Treatment period, during which participants will receive pumitamig or placebo in combination with chemotherapy (until disease progression, the occurrence of intolerable toxicity, withdrawal, death, or trial termination \[whichever comes first\]); 3. Safety follow-up (FU) period (for up to 90 days after administration of the last dose of trial treatment) and survival follow-up (until the participant dies, withdraws consent for survival status follow-up, loss of contact, or sponsor decision, whichever occurs first). Participants will be randomized 1:1 to receive either pumitamig in combination with the treatment of physician's choice (TPC) chemotherapy (Arm 1) or placebo in combination with TPC chemotherapy (Arm 2). Chemotherapy will be administered per standard of care. The randomization will be stratified based on the following factors: * Prior treatment with cancer immunotherapy (yes versus no) * On-trial chemotherapy regimen (paclitaxel/nab-paclitaxel versus gemcitabine plus carboplatin versus eribulin) * Geography (East Asia versus the rest of the world \[ROW\]) * PD-L1 status (combined positive score \[CPS\] less than \[\<\] 1 versus 1 less than or equal to \[\<=\] CPS \<10).

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

Pumitamig

DRUG

Nab-paclitaxel/Paclitaxel

DRUG

Gemcitabine

DRUG

Carboplatin

DRUG

Eribulin

DRUG

Matching placebo

Interested in This Trial?

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Conditions

Breast Neoplasms

Locations

Highlands Oncology Group

Springdale, Arkansas 72762

United States

University Of California - San Diego Moores Cancer Center

La Jolla, California 92037

United States

Cedar Sinai - Samuel Oschin Cancer Center

Los Angeles, California 90048

United States

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

Palo Alto, California 94304-2201

United States

Sacred Heart Medical Oncology Group

Pensacola, Florida 32504

United States

Cancer Care Specialists

Decatur, Illinois 62526

United States

Cancer Care Specialists of Illinois

O'Fallon, Illinois 62269

United States

Carle Foundation Hospital d/b/a Carle Cancer Center

Urbana, Illinois 61801

United States

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

Louisville, Kentucky 40202

United States

New England Cancer Specialists

Westbrook, Maine 04092

United States

Saint Agnes Hospital, Clinical Research Center

Baltimore, Maryland 21229

United States

Lahey Hospital & Medical Center

Burlington, Massachusetts 01805

United States

Karmanos Cancer Center

Detroit, Michigan 48201

United States

Profound Research LLC at Michigan Hematology and Oncology Consultants

Royal Oak, Michigan 48073

United States

Saint Luke's Hospital of Kansas City

Kansas City, Missouri 64111

United States

Oncology Hematology West, PC dba Nebraska Cancer Specialist

Grand Island, Nebraska 68803

United States

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

Omaha, Nebraska 68310

United States

Summit Medical Group PA

Florham Park, New Jersey 07932

United States

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

Livingston, New Jersey 07039

United States

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

Long Branch, New Jersey 07740

United States

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

New Brunswick, New Jersey 08901

United States

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

Newark, New Jersey 07112

United States

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

Somerville, New Jersey 08876

United States

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

Toms River, New Jersey 08755

United States

Paradigm New York Cancer and Blood Specialists

Bay Shore, New York 11706

United States

Paradigm New York Cancer and Blood Specialists

New York, New York 10028

United States

Paradigm New York Cancer and Blood Specialists

New York, New York 10469

United States

Paradigm New York Cancer and Blood Specialists

New York, New York 11042

United States

Paradigm New York Cancer and Blood Specialists

New York, New York 11210

United States

Paradigm New York Cancer and Blood Specialists

New York, New York 11702

United States

Paradigm New York Cancer and Blood Specialists

New York, New York 11772

United States

Paradigm New York Cancer and Blood Specialists

New York, New York 11776

United States

Paradigm New York Cancer and Blood Specialists

New York, New York 11901

United States

Rochester General Hospital Lipson Cancer Institute

Rochester, New York 14621

United States

Stony Brook University Medical Center

Stony Brook, New York 11794

United States

Montefiore Medical Center

The Bronx, New York 10461

United States

Oncology Specialists of Charlotte Pa

Charlotte, North Carolina 28204

United States

Carolina Oncology Specialists

Charlotte, North Carolina 28210

United States

St Charles Bend Cancer Center

Bend, Oregon 97701

United States

St. Charles Cancer Center - Redmond

Redmond, Oregon 97756

United States

Oregon Oncology Specialists

Salem, Oregon 97301

United States

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

Germantown, Tennessee 38002

United States

OneR The Center For Cancer And Blood Disorders (Texas Cancer Care)

Arlington, Texas 76104

United States

OneR The Center For Cancer And Blood Disorders (Texas Cancer Care)

Burleson, Texas 76028

United States

UT Southwestern Medical Center at Redbird

Dallas, Texas 75237

United States

University Of Texas Southwestern Medical Center

Dallas, Texas 75390

United States

JPS Health Network - Trinity Springs Pavilion

Fort Worth, Texas 76104

United States

OneR The Center For Cancer And Blood Disorders (Texas Cancer Care)

Fort Worth, Texas 76104

United States

UT Southwestern Moncrief Cancer Institute

Fort Worth, Texas 76104

United States

Oncology Consultants PA

Houston, Texas 77024

United States

Oncology Consultants PA

Houston, Texas 77030

United States

UT Southwestern Medical Center at Richardson/Plano

Richardson, Texas 75080

United States

OneR The Center For Cancer And Blood Disorders (Texas Cancer Care)

Weatherford, Texas 76068

United States

Bon Secours Cancer Institute at Memorial Regional

Mechanicsville, Virginia 23116

United States

Bon Secours St. Francis Medical Center

Midlothian, Virginia 23114

United States

Bon Secours Cancer Institute at St. Mary's

Richmond, Virginia 23226

United States

Northwest Medical Specialties, PLLC

Tacoma, Washington 98405

United States

Medical College of Wisconsin

Milwaukee, Wisconsin 53226

United States

St Vincent's Hospital - The Kinghorn Cancer Centre

Darlinghurst, New South Wales 2010

Australia

GenesisCare St Andrew's Precinct

Adelaide, South Australia 50000

Australia

Peninsula & South Eastern Hematology and Oncology Group

Frankston, Victoria 3199

Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria 3000

Australia

Monash University - Monash Medical Centre (MMC) - Clayton

Melbourne, Victoria 3168

Australia

Westmead Hospital

Westmead, 2145

Australia

Imeldaziekenhuis

Bonheiden, 2820

Belgium

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

Brussels, 1090

Belgium

Grand hospital de Charleroi

Gilly, 6060

Belgium

University Hospitals Leuven

Leuven, 3000

Belgium

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

Woluwe-Saint-Lambert, 1200

Belgium

Impar Servicos Hospitalares S/A - Hospital Brasilia

Brasília, 71681-603

Brazil

Unidade de Pesquisa Clinica em Oncologia Ltda (UPCO) (Clinica Lacks)

Pelotas, 96020-080

Brazil

Centro de Pesquisa em Oncologia - Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS

Porto Alegre, 90610-000

Brazil

Perola Centro de Pesquisa em Oncologia

São Paulo, 01317-001

Brazil

Associacao Feminina de Educacao e Combate ao Cancer(AFECC) - Hospital Santa Rita

Vitória, 29043-260

Brazil

Changde First People's Hospital

Changde, 415003

China

Shandong Cancer Hospital And Institute

Jinan, 250117

China

Linyi Cancer Hospital

Linyi, 276001

China

Jiangsu Peoples Hospital

Nanjing, 210029

China

Fudan University - Shanghai Cancer Center (FUSCC)

Shanghai, 200032

China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, 450052

China

KOC Pardubickeho kraje Multiscan-Pardubicka nemocnice

Pardubice, 530 03

Czechia

Fakultni Thomayerova nemocnice

Prague, 140 59

Czechia

Fakultni nemocnice Motol a Homolka

Prague, 150 06

Czechia

High Technology Hospital Medcenter LTD

Batumi, 6000

Georgia

Multiprofile Clinic Consilium Medulla

Tbilisi, 0168

Georgia

LLC Todua Clinic

Tbilisi, 112

Georgia

Caucasus Medical Centre

Tbilisi, 186

Georgia

Hämatologische-Onkologische Praxis Augsburg

Augsburg, 86150

Germany

Onkologisch-Haematologische Schwerpunktpraxis

Bremen, 28209

Germany

Praxis Fuer Interdisziplinaere Onkologie & Haematologie

Freiburg im Breisgau, 79106

Germany

SRH Wald-Kliniken Gera GmbH

Gera, 07548

Germany

Mammazentrum Hamburg - Brustklinik am Krankenhaus Jerusalem

Hamburg, 20357

Germany

Institut fuer Versorgungsforschung in der Onkologie

Koblenz, 56068

Germany

Klinikum Nürnberg Nord

Nuremberg, 90419

Germany

Centro di Riferimento Oncologico (CRO)

Aviano, 33081

Italy

Azienda Unità Sanitaria Locale 2 (USL2) Lucca

Lucca, 55100

Italy

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

Milan, 20132

Italy

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, 20133

Italy

IRCCS-Istituto Europeo di Oncologia

Milan, 20141

Italy

ASST Monza-Azienda Ospedaliera San Gerardo

Monza, 20900

Italy

Fondazione Policlinico Universitario Campus Bio-Medico

Roma, 00128

Italy

Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I

Torrette, 60126

Italy

Chiba Cancer Center

Chiba, 260-8717

Japan

Fukushima Medical University Hospital

Fukushima, 960-1295

Japan

Gifu University Hospital

Gifu, 501-1112

Japan

Hiroshima City Hiroshima Citizens Hospital

Hiroshima, 730-8518

Japan

Hakuaikai Medical Corporation Sagara Hospital

Kagoshima, 892-0833

Japan

Kumamoto University Hospital

Kumamoto, 860-8556

Japan

Kyoto University Hospital

Kyoto, 606-8507

Japan

National Hospital Organization Shikoku Cancer Center

Matsuyama, 791-0280

Japan

Nagoya City University Hospital

Nagoya, 467-8602

Japan

Kindai University Hospital

Sakai, 590-0197

Japan

Tohoku University Hospital

Sendai, 980-8574

Japan

National Center For Global Health And Medicine

Shinjuku-Ku, 162-8655

Japan

Uniwersyteckie Centrum Kliniczne

Gdansk, 80-214

Poland

IP Clinic Sp. z o.o.

Lodz, 90-752

Poland

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

Warsaw, 02-781

Poland

Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy

Warsaw, 04-141

Poland

Soon Chun Hyang University Cheonan Hospital

Cheonan, 31151

South Korea

Chungbuk National University Hospital

Cheongju-si, 28644

South Korea

National Cancer Center

Goyang-si, 10408

South Korea

Seoul National University Bundang Hospital (SNUBH)

Seongnam-si, 13620

South Korea

Korea University Anam Hospital

Seoul, 2841

South Korea

Severance Hospital, Yonsei University Health System

Seoul, 3722

South Korea

Asan Medical Center (AMC)

Seoul, 5505

South Korea

Samsung Medical Center

Seoul, 6351

South Korea

Ajou University Hospital

Suwon, 16499

South Korea

Hospital Universitario de Badajoz

Badajoz, 6006

Spain

Parc de Salut Mar - Hospital del Mar

Barcelona, 8003

Spain

Institut Oncologic Rosell - Hospital General De Catalunya

Barcelona, 8195

Spain

Hospital Universitario Reina Sofia

Córdoba, 14004

Spain

IOB Institute of Oncology - Beata Maria Ana Hospital

Madrid, 28007

Spain

Universidad de Navarra - Clinica Universidad de Navarra (CUN)

Madrid, 28027

Spain

Hospital Universitario Fundación Jiménez Díaz

Madrid, 28040

Spain

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

Madrid, 28050

Spain

Hospital General Universitario Morales Meseguer

Murcia, 30008

Spain

Hospital Universitario Virgen De La Arrixaca (Huva)

Murcia, 30120

Spain

Universidad de Navarra - Clínica Universidad de Navarra (CUN)

Pamplona, 31008

Spain

Hospital Universitari Parc Tauli

Sabadell, 8208

Spain

Fundación Instituto Valenciano de Oncología

Valencia, 46009

Spain

Royal Sussex County Hospital - University Hospitals Sussex NHS Foundation Trust

Brighton, BN2 5BE

United Kingdom

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

Bristol, BS2 8ED

United Kingdom

Hull and East Yorkshire Hospitals NHS Trust - Castle Hill Hospital

Cottingham, HU16 5JQ

United Kingdom

Edinburgh Cancer Centre-Western General Hospital

Edinburgh, EH4 2LF

United Kingdom

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

Leeds, LS9 7TF

United Kingdom

St Bartholomew's Hospital - Barts Health NHS Trust

London, EC1A 7BE

United Kingdom

University College London Hospitals NHS Foundation Trust

London, NW2 1PG

United Kingdom

The Royal Free Hospital - Royal Free London NHS Foundation Trust

London, NW3 2QG

United Kingdom

Sarah Cannon Research Institute

London, W1G 6AD

United Kingdom

Churchill Hospital - Oxford University Hospitals NHS Foundation Trust

Oxford, OX3 7LE

United Kingdom

North Wales Cancer Treatment C - Glan Clwyd Hospital

Rhyl, LL18 5UJ

United Kingdom

Southampton General Hospital - University Hospital Southampton NHS Foundation Trust

Southampton, SO16 6YD

United Kingdom

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

Stoke-on-Trent, ST4 6QG

United Kingdom

Torbay Hosptial, South Devon Healthcare NHS Foundation Trust

Torquay, TQ2 7AA

United Kingdom

New Cross Hospital - The Royal Wolverhampton NHS Trust

Wolverhampton, WV10 0QP

United Kingdom