ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer
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
Interventions
Pumitamig
Nab-paclitaxel/Paclitaxel
Gemcitabine
Carboplatin
Eribulin
Matching placebo
Conditions
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