Breast NeoplasmsPhase 3NCT07173751
ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer
A Phase 3 study testing Pumitamig, Nab-paclitaxel/Paclitaxel and Gemcitabine in people with Breast Neoplasms, run by BioNTech SE at 217 sites in 19 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Pumitamig, Nab-paclitaxel/Paclitaxel and Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 558 participants
- Where
- 217 sitesin 19 countries
- Study dates
- 30 Oct 2025to Sep 2030
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
217 sites in 19 countries. Contact the study team or a site near you to ask about taking part.
217 sites in 19 countries
United States71 sites, 71 recruiting
- Recruiting
OneR The Center For Cancer And Blood Disorders (Texas Cancer Care)
Arlington, Texas, 76104
- Recruiting
Saint Agnes Hospital, Clinical Research Center
Baltimore, Maryland, 21229
- Recruiting
Paradigm New York Cancer and Blood Specialists
Bay Shore, New York, 11706
- Recruiting
St Charles Bend Cancer Center
Bend, Oregon, 97701
- Recruiting
OneR The Center For Cancer And Blood Disorders (Texas Cancer Care)
Burleson, Texas, 76028
- Recruiting
Lahey Hospital & Medical Center
Burlington, Massachusetts, 01805
- Recruiting
Oncology Specialists of Charlotte Pa
Charlotte, North Carolina, 28204
- Recruiting
Carolina Oncology Specialists
Charlotte, North Carolina, 28210
- Recruiting
Maryland Oncology Hematology P.A.
Columbia, Maryland, 21044
- Recruiting
UT Southwestern Medical Center at Redbird
Dallas, Texas, 75237
- Recruiting
University Of Texas Southwestern Medical Center
Dallas, Texas, 75390
- Recruiting
Cancer Care Specialists
Decatur, Illinois, 62526
- Recruiting
Karmanos Cancer Center
Detroit, Michigan, 48201
- Recruiting
Summit Medical Group PA
Florham Park, New Jersey, 07932
- Recruiting
Florida Cancer Specialists
Fort Myers, Florida, 33916
- Recruiting
JPS Health Network - Trinity Springs Pavilion
Fort Worth, Texas, 76104
- Recruiting
OneR The Center For Cancer And Blood Disorders (Texas Cancer Care)
Fort Worth, Texas, 76104
- Recruiting
UT Southwestern Moncrief Cancer Institute
Fort Worth, Texas, 76104
- Recruiting
The West Clinic, P.C. dba West Cancer Center
Germantown, Tennessee, 38002
- Recruiting
Oncology Hematology West, PC dba Nebraska Cancer Specialist
Grand Island, Nebraska, 68803
- Recruiting
Oncology Consultants PA
Houston, Texas, 77024
- Recruiting
Oncology Consultants PA
Houston, Texas, 77030
- Recruiting
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
- Recruiting
University Of California - San Diego Moores Cancer Center
La Jolla, California, 92037
- Recruiting
Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey)
Livingston, New Jersey, 07039
- Recruiting
Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey)
Long Branch, New Jersey, 07740
- Recruiting
Cancer and Blood Specialty Clinic (CBSC)
Los Alamitos, California, 90720-3309
- Recruiting
Cedar Sinai - Samuel Oschin Cancer Center
Los Angeles, California, 90048
- Recruiting
University Medical Center, Inc. DBA University of Louisville Hospital/James Graham Brown Cancer Center
Louisville, Kentucky, 40202
- Recruiting
Bon Secours Cancer Institute at Memorial Regional
Mechanicsville, Virginia, 23116
- Recruiting
Bon Secours St. Francis Medical Center
Midlothian, Virginia, 23114
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
- Recruiting
Tennessee Oncology
Nashville, Tennessee, 37203
- Recruiting
Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey)
New Brunswick, New Jersey, 08901
- Recruiting
Paradigm New York Cancer and Blood Specialists
New York, New York, 10028
- Recruiting
Paradigm New York Cancer and Blood Specialists
New York, New York, 10469
- Recruiting
Paradigm New York Cancer and Blood Specialists
New York, New York, 11042
- Recruiting
Paradigm New York Cancer and Blood Specialists
New York, New York, 11210
- Recruiting
Paradigm New York Cancer and Blood Specialists
New York, New York, 11702
- Recruiting
Paradigm New York Cancer and Blood Specialists
New York, New York, 11772
- Recruiting
Paradigm New York Cancer and Blood Specialists
New York, New York, 11776
- Recruiting
Paradigm New York Cancer and Blood Specialists
New York, New York, 11901
- Recruiting
Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey)
Newark, New Jersey, 07112
- Recruiting
Cancer Care Specialists of Illinois
O'Fallon, Illinois, 62269
- Recruiting
Paradigm Oncology Hematology West P.C. dba Nebraska Cancer Specialists
Omaha, Nebraska, 68310
- Recruiting
Cancer Care Centers of Brevard, Inc
Palm Bay, Florida, 32901
- Recruiting
Stanford University School of Medicine - Stanford Cancer Institute (SCI) - Stanford Women's Cancer Center
Palo Alto, California, 94304-2201
- Recruiting
Sacred Heart Medical Oncology Group
Pensacola, Florida, 32504
- Recruiting
Providence Portland Medical Center
Portland, Oregon, 97213
- Recruiting
St. Charles Cancer Center - Redmond
Redmond, Oregon, 97756
- Recruiting
UT Southwestern Medical Center at Richardson/Plano
Richardson, Texas, 75080
- Recruiting
Bon Secours Cancer Institute at St. Mary's
Richmond, Virginia, 23226
- Recruiting
Rochester General Hospital Lipson Cancer Institute
Rochester, New York, 14621
- Recruiting
Profound Research LLC at Michigan Hematology and Oncology Consultants
Royal Oak, Michigan, 48073
- Recruiting
University Of California Davis Health System
Sacramento, California, 95817-2229
- Recruiting
Healthpartners Regions Specialty Clinics
Saint Louis Park, Minnesota, 55426
- Recruiting
Healthpartners Regions Specialty Clinics
Saint Paul, Minnesota, 55101-2502
- Recruiting
Oregon Oncology Specialists
Salem, Oregon, 97301
- Recruiting
Sansum Clinic
Santa Barbara, California, 93105
- Recruiting
Saint John's Health Center - John Wayne Cancer Institute (JWCI)
Santa Monica, California, 90404-2312
- Recruiting
Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey)
Somerville, New Jersey, 08876
- Recruiting
Highlands Oncology Group
Springdale, Arkansas, 72762
- Recruiting
Florida Cancer Specialists North
St. Petersburg, Florida, 33701
- Recruiting
Stony Brook University Medical Center
Stony Brook, New York, 11794
- Recruiting
Northwest Medical Specialties, PLLC
Tacoma, Washington, 98405
- Recruiting
Montefiore Medical Center
The Bronx, New York, 10461
- Recruiting
Renovatio Clinical - The Woodlands Research Center
The Woodlands, Texas, 77380
- Recruiting
Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey)
Toms River, New Jersey, 08755
- Recruiting
Carle Foundation Hospital d/b/a Carle Cancer Center
Urbana, Illinois, 61801
- Recruiting
OneR The Center For Cancer And Blood Disorders (Texas Cancer Care)
Weatherford, Texas, 76068
- Recruiting
New England Cancer Specialists
Westbrook, Maine, 04092
Japan18 sites, 18 recruiting
- Recruiting
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Bunkyō City, 113-8677
- Recruiting
Chiba Cancer Center
Chiba, 260-8717
- Recruiting
Fukushima Medical University Hospital
Fukushima, 960-1295
- Recruiting
Gifu University Hospital
Gifu, 501-1112
- Recruiting
Saitama Medical University International Medical Center
Hidaka, 350-1298
- Recruiting
Hiroshima City Hiroshima Citizens Hospital
Hiroshima, 730-8518
- Recruiting
Hakuaikai Medical Corporation Sagara Hospital
Kagoshima, 892-0833
- Recruiting
The Cancer Institute Hospital of JFCR
Kōtoku, 135-8550
- Recruiting
Kumamoto University Hospital
Kumamoto, 860-8556
- Recruiting
Kyoto University Hospital
Kyoto, 606-8507
- Recruiting
National Hospital Organization Shikoku Cancer Center
Matsuyama, 791-0280
- Recruiting
Shizuoka Cancer Center
Nagaizumi-chō, 411-8777
- Recruiting
Nagoya City University Hospital
Nagoya, 467-8602
- Recruiting
Osaka International Cancer Institute
Osaka, 541-8567
- Recruiting
Kindai University Hospital
Sakai, 590-0197
- Recruiting
Tohoku University Hospital
Sendai, 980-8574
- Recruiting
National Center For Global Health And Medicine
Shinjuku-Ku, 162-8655
- Recruiting
Mie University Graduate School Of Medicine
Tsu, 514-8507
China15 sites, 15 recruiting
- Recruiting
Changde First People's Hospital
Changde, 415003
- Recruiting
Affiliated Cancer Hospital of Harbin Medical University
Harbin, 150006
- Recruiting
The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
Hefei, 230001
- Recruiting
Shandong Cancer Hospital And Institute
Jinan, 250117
- Recruiting
The First Hospital of Lanzhou University
Lanzhou, 730000
- Recruiting
Linyi Cancer Hospital
Linyi, 276001
- Recruiting
Nanchang People's Hospital
Nanchang, 330025
- Recruiting
Jiangsu Peoples Hospital
Nanjing, 210029
- Recruiting
The Second Peoples Hospital of Neijiang
Neijiang, 641000
- Recruiting
Fudan University - Shanghai Cancer Center (FUSCC)
Shanghai, 200032
- Recruiting
Shanxi Provincial Tumor Hospital (Shanxi Oncology Hospital)
Taiyuan, 30013
- Recruiting
Zhongnan Hospital of Wuhan University
Wuhan, 430071
- Recruiting
Xi'an International Medical Center Hospital
Xi'an, 710100
- Recruiting
The Central Hospital of Yongzhou - North Campus
Yongzhou, 425000
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, 450052
United Kingdom15 sites, 15 recruiting
- Recruiting
Royal Sussex County Hospital - University Hospitals Sussex NHS Foundation Trust
Brighton, BN2 5BE
- Recruiting
University Hospitals Bristol and Weston NHS Foundation Trust, Bristol Haematology & Oncology Centre
Bristol, BS2 8ED
- Recruiting
Hull and East Yorkshire Hospitals NHS Trust - Castle Hill Hospital
Cottingham, HU16 5JQ
- Recruiting
Edinburgh Cancer Centre-Western General Hospital
Edinburgh, EH4 2LF
- Recruiting
St James's University Hospital - Leeds Teaching Hospitals NHS Trust
Leeds, LS9 7TF
- Recruiting
St Bartholomew's Hospital - Barts Health NHS Trust
London, EC1A 7BE
- Recruiting
University College London Hospitals NHS Foundation Trust
London, NW2 1PG
- Recruiting
The Royal Free Hospital - Royal Free London NHS Foundation Trust
London, NW3 2QG
- Recruiting
Sarah Cannon Research Institute
London, W1G 6AD
- Recruiting
Churchill Hospital - Oxford University Hospitals NHS Foundation Trust
Oxford, OX3 7LE
- Recruiting
North Wales Cancer Treatment C - Glan Clwyd Hospital
Rhyl, LL18 5UJ
- Recruiting
Southampton General Hospital - University Hospital Southampton NHS Foundation Trust
Southampton, SO16 6YD
- Recruiting
Royal Stoke University Hospital - University Hospitals of North Midlands NHS Trust
Stoke-on-Trent, ST4 6QG
- Recruiting
Torbay Hosptial, South Devon Healthcare NHS Foundation Trust
Torquay, TQ2 7AA
- Recruiting
New Cross Hospital - The Royal Wolverhampton NHS Trust
Wolverhampton, WV10 0QP
Spain13 sites, 13 recruiting
- Recruiting
Hospital Universitario de Badajoz
Badajoz, 6006
- Recruiting
Parc de Salut Mar - Hospital del Mar
Barcelona, 8003
- Recruiting
Institut Oncologic Rosell - Hospital General De Catalunya
Barcelona, 8195
- Recruiting
Hospital Universitario Reina Sofia
Córdoba, 14004
- Recruiting
IOB Institute of Oncology - Beata Maria Ana Hospital
Madrid, 28007
- Recruiting
Universidad de Navarra - Clinica Universidad de Navarra (CUN)
Madrid, 28027
- Recruiting
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040
- Recruiting
Hospital Universitario Madrid Sanchinarro - Centro Integral Oncologico Clara Campal (CIOCC)
Madrid, 28050
- Recruiting
Hospital General Universitario Morales Meseguer
Murcia, 30008
- Recruiting
Hospital Universitario Virgen De La Arrixaca (Huva)
Murcia, 30120
- Recruiting
Universidad de Navarra - Clínica Universidad de Navarra (CUN)
Pamplona, 31008
- Recruiting
Hospital Universitari Parc Tauli
Sabadell, 8208
- Recruiting
Fundación Instituto Valenciano de Oncología
Valencia, 46009
Brazil11 sites, 11 recruiting
- Recruiting
Impar Servicos Hospitalares S/A - Hospital Brasilia
Brasília, 71681-603
- Recruiting
Liga Paranaense de Combate ao Cancer - Hospital Erasto Gaertner
Curitiba, 81520-060
- Recruiting
Associacao de Combate ao Cancer em Goias Hospital Araujo Jorge
Goiânia, 74605-070
- Recruiting
Unidade de Pesquisa Clinica em Oncologia Ltda (UPCO) (Clinica Lacks)
Pelotas, 96020-080
- Recruiting
Hospital de Clinicas de Porto Alegre (HCPA)
Porto Alegre, 90035-903
- Recruiting
Centro de Quimioterapia
Porto Alegre, 90440
- Recruiting
Centro de Pesquisa em Oncologia - Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
Porto Alegre, 90610-000
- Recruiting
Perola Centro de Pesquisa em Oncologia
São Paulo, 01317-001
- Recruiting
Hospital Alemao Oswaldo Cruz (HAOC)
São Paulo, 01327-001
- Recruiting
Hospital Santa Marcelina
São Paulo, 8270
- Recruiting
Associacao Feminina de Educacao e Combate ao Cancer(AFECC) - Hospital Santa Rita
Vitória, 29043-260
Germany9 sites, 9 recruiting
- Recruiting
Hämatologische-Onkologische Praxis Augsburg
Augsburg, 86150
- Recruiting
Onkologisch-Haematologische Schwerpunktpraxis
Bremen, 28209
- Recruiting
Universitätsklinikum Frankfurt
Frankfurt, 60590
- Recruiting
Praxis Fuer Interdisziplinaere Onkologie & Haematologie
Freiburg im Breisgau, 79106
- Recruiting
SRH Wald-Kliniken Gera GmbH
Gera, 07548
- Recruiting
Mammazentrum Hamburg - Brustklinik am Krankenhaus Jerusalem
Hamburg, 20357
- Recruiting
Institut fuer Versorgungsforschung in der Onkologie
Koblenz, 56068
- Recruiting
Universitätsmedizin Mannheim GmbH
Mannheim, 68167
- Recruiting
Klinikum Nürnberg Nord
Nuremberg, 90419
Italy9 sites, 9 recruiting
- Recruiting
Centro di Riferimento Oncologico (CRO)
Aviano, 33081
- Recruiting
Azienda Unità Sanitaria Locale 2 (USL2) Lucca
Lucca, 55100
- Recruiting
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele)
Milan, 20132
- Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133
- Recruiting
IRCCS-Istituto Europeo di Oncologia
Milan, 20141
- Recruiting
ASST Monza-Azienda Ospedaliera San Gerardo
Monza, 20900
- Recruiting
Azienda Ospedaliera Universitaria Pisana
Pisa, 56124
- Recruiting
Fondazione Policlinico Universitario Campus Bio-Medico
Roma, 00128
- Recruiting
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I
Torrette, 60126
Poland9 sites, 9 recruiting
- Recruiting
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-214
- Recruiting
SP ZOZ Szpital Uniwersytecki w Krakowie
Krakow, 30688
- Recruiting
Instytut MSF Sp. z o.o.
Lodz, 90-302
- Recruiting
IP Clinic Sp. z o.o.
Lodz, 90-752
- Recruiting
Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli
Lublin, 20-090
- Recruiting
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, 60-569
- Recruiting
Narodowy Insytut Onkologii im. Marii Sklodowskiej-Curie - Państwowy Instytut Badawczy
Warsaw, 02-781
- Recruiting
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
Warsaw, 04-141
- Recruiting
LUX MED Onkologia Szpital Szamocka
Warsaw, 1748
South Korea9 sites, 9 recruiting
- Recruiting
Soon Chun Hyang University Cheonan Hospital
Cheonan, 31151
- Recruiting
Chungbuk National University Hospital
Cheongju-si, 28644
- Recruiting
National Cancer Center
Goyang-si, 10408
- Recruiting
Seoul National University Bundang Hospital (SNUBH)
Seongnam-si, 13620
- Recruiting
Korea University Anam Hospital
Seoul, 2841
- Recruiting
Severance Hospital, Yonsei University Health System
Seoul, 3722
- Recruiting
Asan Medical Center (AMC)
Seoul, 5505
- Recruiting
Samsung Medical Center
Seoul, 6351
- Recruiting
Ajou University Hospital
Suwon, 16499
Argentina8 sites, 8 recruiting
- Recruiting
Hospital Aleman
Buenos Aires, 569811
- Recruiting
Centro Medico Austral
Buenos Aires, C1019ABS
- Recruiting
Clinica Adventista Belgrano (CAB)
Caba, C1430EGF
- Recruiting
Breast Clínica de la Mama
La Plata, B1902
- Recruiting
Sanatorio de La Mujer
Rosario, S2000ORE
- Recruiting
Centro Oncologico de Excelencia (COE)
San Juan, 5400
- Recruiting
Exelsus SRL
San Miguel de Tucumán, T4000IAM
- Recruiting
Centro de Investigaciones Clinicas. Clinica Viedma S. A
Viedma, R8500JYJ
Australia6 sites, 6 recruiting
- Recruiting
GenesisCare St Andrew's Precinct
Adelaide, South Australia, 50000
- Recruiting
St Vincent's Hospital - The Kinghorn Cancer Centre
Darlinghurst, New South Wales, 2010
- Recruiting
Peninsula & South Eastern Hematology and Oncology Group
Frankston, Victoria, 3199
- Recruiting
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
- Recruiting
Monash University - Monash Medical Centre (MMC) - Clayton
Melbourne, Victoria, 3168
- Recruiting
Westmead Hospital
Westmead, 2145
Belgium5 sites, 5 recruiting
- Recruiting
Imeldaziekenhuis
Bonheiden, 2820
- Recruiting
Universitair Ziekenhuis Brussel (AZ-VUB - Academisch Ziekenhuis der Vrije Universiteit Brussel)
Brussels, 1090
- Recruiting
Grand hospital de Charleroi
Gilly, 6060
- Recruiting
University Hospitals Leuven
Leuven, 3000
- Recruiting
Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, 1200
Czechia4 sites, 4 recruiting
- Recruiting
Fakultni Nemocnice Ostrava
Nový Jičín, 74101
- Recruiting
KOC Pardubickeho kraje Multiscan-Pardubicka nemocnice
Pardubice, 530 03
- Recruiting
Fakultni Thomayerova nemocnice
Prague, 140 59
- Recruiting
Fakultni nemocnice Motol a Homolka
Prague, 150 06
Georgia4 sites, 4 recruiting
- Recruiting
High Technology Hospital Medcenter LTD
Batumi, 6000
- Recruiting
Multiprofile Clinic Consilium Medulla
Tbilisi, 0168
- Recruiting
LLC Todua Clinic
Tbilisi, 112
- Recruiting
Caucasus Medical Centre
Tbilisi, 186
Mexico4 sites, 4 recruiting
- Recruiting
Centro de Investigacion Oncologica Galeias
Aguascalientes, 20120
- Recruiting
Centro De Atencion Oncologica Viva
Mexico City, 06760
- Recruiting
Onco Pall Advance Care Oncology Center Sa de CV
Monterrey, 64320
- Recruiting
Investigacion Biomedica para el Desarrollo de Nuevos Farmacos SA de CV
Zapopan, 45070
Singapore3 sites, 3 recruiting
- Recruiting
National Cancer Centre Singapore
Singapore, 168583
- Recruiting
Tan Tock Seng Hospital
Singapore, 308433
- Recruiting
Curie Oncology
Singapore, 329563
Canada2 sites, 2 recruiting
- Recruiting
Centre Hospitalier Universitaire De Sherbrooke (CHUS) - Centre de Recherche Clinique Etienne-Le Bel (CRCELB) Hopital Fleurimont
Québec, J1H 5N4
- Recruiting
Sunnybrook Research Unit-Cognitive Neurology Research Unit in the Hurvitz Brain Science Research Program
Toronto, M4H 3M5
Netherlands2 sites, 2 recruiting
- Recruiting
Maastricht University Medical Center (MUMC)
Maastricht, 6229 HX
- Recruiting
Haga Ziekenhuis, Locatie Leyweg
The Hague, 2545 CH
About this study
Official title: A Phase III, Multisite, Randomized, Double-Blind Trial of BNT327 in Combination With Chemotherapy Versus Placebo With Chemotherapy in Patients With Previously Untreated Locally Recurrent Inoperable or Metastatic TNBC Determined Ineligible for PD(L)1 Therapy Based on PD-L1 Negative Disease
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.
Read the detailed description
The study consists of a:
- Screening period (up to 28 days);
- 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]);
- 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).
- Conditions
- Breast Neoplasms
- Being tested
- Pumitamig, Nab-paclitaxel/Paclitaxel, Gemcitabine, Carboplatin, Eribulin
- Keywords
- Metastatic TNBC, Bispecific antibody, Programmed death-ligand 1 (PD-L1), Immunotherapy, Immunotherapy in combination with chemotherapy, Combination with other investigational agents
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PumitamigDrug
Also called BNT327, PM8002, BMS-986545
Solution for intravenous (IV) infusion
Nab-paclitaxel/PaclitaxelDrug
IV infusion
GemcitabineDrug
IV infusion
CarboplatinDrug
IV infusion
EribulinDrug
IV infusion
Matching placeboDrug
IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Pumitamig + Treatment of Physician's Choice (TPC) Chemotherapy | Experimental | Participants will be administered with pumitamig (BNT327) plus chemotherapy regimen. Receives: 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. Receives: Drug: Nab-paclitaxel/Paclitaxel; Drug: Gemcitabine; Drug: Carboplatin; Drug: Eribulin; Drug: Matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to approximately 32 months
Overall Survival (OS)
OS is defined as the time from randomization to death from any cause.
Measured: Up to approximately 49 months
Secondary outcomes (15)
Objective Response Rate (ORR) as Assessed by BICR
ORR is defined as the percentage of participants in whom a confirmed complete response (CR) or confirmed partial response (PR) as per RECIST v1.1 is assessed by BICR as best overall response.
Measured: Up to approximately 49 months
PFS
PFS is defined as the time from randomization to first documented tumor progression (progressive disease assessed by investigator per RECIST v1.1), or death from any cause, whichever occurs first.
Measured: Up to approximately 32 months
ORR
ORR is defined as the percentage of participants in whom a confirmed CR or confirmed PR (per RECIST v1.1) is observed as best overall response.
Measured: Up to approximately 49 months
Duration of Response (DOR)
DOR is defined as the time from first objective response (CR or PR per RECIST v1.1) to first occurrence of objective tumor progression (progressive disease per RECIST v1.1), or death from any cause, whichever occurs first.
Measured: Up to approximately 49 months
Disease Control Rate (DCR)
DCR is defined as the percentage of participants in whom a confirmed CR or confirmed PR or stable disease (SD) (per RECIST v1.1, SD assessed at least 6 weeks after randomization) is observed as best overall response.
Measured: Up to approximately 32 months
PFS Rate as Assessed by BICR
Measured: At 6, 12, 18, and 24 months
PFS Rate as Assessed by Investigator
Measured: At 6, 12, 18, and 24 months
OS Rate
Measured: At 6, 12, 18, and 24 months
Occurrence of Treatment-Emergent Adverse Events (TEAEs) Including Grade Greater than or Equal to (>=) 3, Serious, and Fatal TEAEs by Relationship
TEAEs graded according to United Stated (US) National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0)
Measured: From the first dose of study treatment to the 90-days after last dose of study treatment (up to approximately 57 months)
Occurrence of Dose Interruption, Reduction, and Discontinuation of Trial Treatment due to TEAEs (including related TEAEs)
Measured: From the first dose of study treatment to the 90-days after last dose of study treatment (up to approximately 57 months)
Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Core 30 Questionnaire (QLQ-C30) Global Health Status/Quality-of-Life score (Items 29 and 30)
Global health status or quality of life (QoL) scale ranges in score from 0 to 100 with a high scale score representing a higher response level (for example, high score for global health status/QoL is high QoL: high score for symptom scale/item is high symptomatology or problems).
Measured: Baseline up to approximately 49 months
Change from Baseline in EORTC QLQ-C30 Physical Functioning
Physical functioning scale ranges in score from 0 to 100 with a high scale score representing a higher response level (for example, high score for functional scale is high/healthy level of functioning).
Measured: Baseline up to approximately 49 months
Change from Baseline in Arm Symptoms Scale of EORTC QLQ-Breast Cancer (BR)42
Arm symptom scale ranges in score from 0 to 100 with a high scale score representing a higher level of symptoms or problems.
Measured: Baseline up to approximately 49 months
Change from Baseline in Breast Symptoms Scale of EORTC QLQ-BR42
Breast symptom scale ranges in score from 0 to 100 with a high scale score representing a higher level of symptoms or problems.
Measured: Baseline up to approximately 49 months
Change from Baseline in Functional Assessment of Cancer Therapy-General Version (FACT-G) Overall Bother Item (FACT-GP5)
The single-item GP5, that is "I am bothered by side effects of treatment," is rated on a 5-point Likert scale (where 1=not at all and 5=very much) by the participants. A high scale score represents worse outcome.
Measured: Baseline up to approximately 49 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start30 Oct 2025
- Primary completionDec 2029 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by BioNTech SEThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 558 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioNTech SE
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- BioNTech Responsible Person, Study director, BioNTech SE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07173751
- Sponsor's protocol ID
- BNT327-05
- Other IDs
- 2025-521884-12-00, 2025
- Status last verified
- Oct 2026
- First submitted
- 8 Sep 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No