New hope for Hard-to-Treat breast cancer: BNT327 combo enters phase 3 trial

NCT ID NCT07173751

Recruiting now Disease control Sponsor: BioNTech SE Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jul 17, 2026 · Updated 2 times

Summary

This phase 3 trial tests whether adding the experimental drug BNT327 to standard chemotherapy helps people with advanced triple-negative breast cancer (TNBC) live longer without their cancer growing. Participants have TNBC that cannot be treated with current PD(L)1 immunotherapies. About 558 volunteers will be randomly assigned to receive either BNT327 plus chemo or a placebo plus chemo. Neither they nor their doctors will know which group they are in. The study measures how long it takes for the cancer to progress and overall survival.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: BNT327 (also called pumitamig) combined with chemotherapy drugs (nab-paclitaxel, paclitaxel, gemcitabine, carboplatin, or eribulin)
What this could lead to: If successful, this could offer a new treatment option for people with advanced triple-negative breast cancer who cannot receive standard immunotherapy, potentially slowing cancer growth and extending survival.
What could go wrong: This is a large phase 3 trial, but the drug is still experimental. It may not prove more effective than chemotherapy alone, and side effects from the combination could be significant.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

breast neoplasm triple-negative breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

BREAST NEOPLASMS

Contacts and locations

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Study contacts

Contact

Phone: •••-•••-•••• Email: •••••@•••••

Locations

ASST Monza-Azienda Ospedaliera San Gerardo
RECRUITING

Monza, 20900, Italy
Ajou University Hospital
RECRUITING

Suwon, 16499, South Korea
Asan Medical Center (AMC)
RECRUITING

Seoul, 5505, South Korea
Associacao Feminina de Educacao e Combate ao Cancer(AFECC) - Hospital Santa Rita
RECRUITING

Vitória, 29043-260, Brazil
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I
RECRUITING

Torrette, 60126, Italy
Azienda Unità Sanitaria Locale 2 (USL2) Lucca
RECRUITING

Lucca, 55100, Italy
Bon Secours Cancer Institute at Memorial Regional
RECRUITING

Mechanicsville, Virginia, 23116, United States
Bon Secours Cancer Institute at St. Mary's
RECRUITING

Richmond, Virginia, 23226, United States
Bon Secours St. Francis Medical Center
RECRUITING

Midlothian, Virginia, 23114, United States
Cancer Care Specialists
RECRUITING

Decatur, Illinois, 62526, United States
Cancer Care Specialists of Illinois
RECRUITING

O'Fallon, Illinois, 62269, United States
Carle Foundation Hospital d/b/a Carle Cancer Center
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Urbana, Illinois, 61801, United States
Carolina Oncology Specialists
RECRUITING

Charlotte, North Carolina, 28210, United States
Caucasus Medical Centre
RECRUITING

Tbilisi, 186, Georgia
Cedar Sinai - Samuel Oschin Cancer Center
RECRUITING

Los Angeles, California, 90048, United States
Centro de Pesquisa em Oncologia - Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
RECRUITING

Porto Alegre, 90610-000, Brazil
Centro di Riferimento Oncologico (CRO)
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Aviano, 33081, Italy
Changde First People's Hospital
RECRUITING

Changde, 415003, China
Chiba Cancer Center
RECRUITING

Chiba, 260-8717, Japan
Chungbuk National University Hospital
RECRUITING

Cheongju-si, 28644, South Korea
Churchill Hospital - Oxford University Hospitals NHS Foundation Trust
RECRUITING

Oxford, OX3 7LE, United Kingdom
Edinburgh Cancer Centre-Western General Hospital
RECRUITING

Edinburgh, EH4 2LF, United Kingdom
Fakultni Thomayerova nemocnice
RECRUITING

Prague, 140 59, Czechia
Fakultni nemocnice Motol a Homolka
RECRUITING

Prague, 150 06, Czechia
Fondazione IRCCS Istituto Nazionale dei Tumori
RECRUITING

Milan, 20133, Italy
Fondazione Policlinico Universitario Campus Bio-Medico
RECRUITING

Roma, 00128, Italy
Fudan University - Shanghai Cancer Center (FUSCC)
RECRUITING

Shanghai, 200032, China
Fukushima Medical University Hospital
RECRUITING

Fukushima, 960-1295, Japan
Fundación Instituto Valenciano de Oncología
RECRUITING

Valencia, 46009, Spain
GenesisCare St Andrew's Precinct
RECRUITING

Adelaide, South Australia, 50000, Australia
Gifu University Hospital
RECRUITING

Gifu, 501-1112, Japan
Grand hospital de Charleroi
RECRUITING

Gilly, 6060, Belgium
Hakuaikai Medical Corporation Sagara Hospital
RECRUITING

Kagoshima, 892-0833, Japan
High Technology Hospital Medcenter LTD
RECRUITING

Batumi, 6000, Georgia
Highlands Oncology Group
RECRUITING

Springdale, Arkansas, 72762, United States
Hiroshima City Hiroshima Citizens Hospital
RECRUITING

Hiroshima, 730-8518, Japan
Hospital General Universitario Morales Meseguer
RECRUITING

Murcia, 30008, Spain
Hospital Universitari Parc Tauli
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Sabadell, 8208, Spain
Hospital Universitario Fundación Jiménez Díaz
RECRUITING

Madrid, 28040, Spain
Hospital Universitario Madrid Sanchinarro - Centro Integral Oncologico Clara Campal (CIOCC)
RECRUITING

Madrid, 28050, Spain
Hospital Universitario Reina Sofia
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Córdoba, 14004, Spain
Hospital Universitario Virgen De La Arrixaca (Huva)
RECRUITING

Murcia, 30120, Spain
Hospital Universitario de Badajoz
RECRUITING

Badajoz, 6006, Spain
Hull and East Yorkshire Hospitals NHS Trust - Castle Hill Hospital
RECRUITING

Cottingham, HU16 5JQ, United Kingdom
Hämatologische-Onkologische Praxis Augsburg
RECRUITING

Augsburg, 86150, Germany
IOB Institute of Oncology - Beata Maria Ana Hospital
RECRUITING

Madrid, 28007, Spain
IP Clinic Sp. z o.o.
RECRUITING

Lodz, 90-752, Poland
IRCCS-Istituto Europeo di Oncologia
RECRUITING

Milan, 20141, Italy
Imeldaziekenhuis
RECRUITING

Bonheiden, 2820, Belgium
Impar Servicos Hospitalares S/A - Hospital Brasilia
RECRUITING

Brasília, 71681-603, Brazil
Institut Oncologic Rosell - Hospital General De Catalunya
RECRUITING

Barcelona, 8195, Spain
Institut fuer Versorgungsforschung in der Onkologie
RECRUITING

Koblenz, 56068, Germany
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele)
RECRUITING

Milan, 20132, Italy
JPS Health Network - Trinity Springs Pavilion
RECRUITING

Fort Worth, Texas, 76104, United States
Jiangsu Peoples Hospital
RECRUITING

Nanjing, 210029, China
KOC Pardubickeho kraje Multiscan-Pardubicka nemocnice
RECRUITING

Pardubice, 530 03, Czechia
Karmanos Cancer Center
RECRUITING

Detroit, Michigan, 48201, United States
Kindai University Hospital
RECRUITING

Sakai, 590-0197, Japan
Klinikum Nürnberg Nord
RECRUITING

Nuremberg, 90419, Germany
Korea University Anam Hospital
RECRUITING

Seoul, 2841, South Korea
Kumamoto University Hospital
RECRUITING

Kumamoto, 860-8556, Japan
Kyoto University Hospital
RECRUITING

Kyoto, 606-8507, Japan
LLC Todua Clinic
RECRUITING

Tbilisi, 112, Georgia
Lahey Hospital & Medical Center
RECRUITING

Burlington, Massachusetts, 01805, United States
Linyi Cancer Hospital
RECRUITING

Linyi, 276001, China
Mammazentrum Hamburg - Brustklinik am Krankenhaus Jerusalem
RECRUITING

Hamburg, 20357, Germany
Medical College of Wisconsin
RECRUITING

Milwaukee, Wisconsin, 53226, United States
Monash University - Monash Medical Centre (MMC) - Clayton
RECRUITING

Melbourne, Victoria, 3168, Australia
Montefiore Medical Center
RECRUITING

The Bronx, New York, 10461, United States
Multiprofile Clinic Consilium Medulla
RECRUITING

Tbilisi, 0168, Georgia
Nagoya City University Hospital
RECRUITING

Nagoya, 467-8602, Japan
Narodowy Insytut Onkologii im. Marii Sklodowskiej-Curie - Państwowy Instytut Badawczy
RECRUITING

Warsaw, 02-781, Poland
National Cancer Center
RECRUITING

Goyang-si, 10408, South Korea
National Center For Global Health And Medicine
RECRUITING

Shinjuku-Ku, 162-8655, Japan
National Hospital Organization Shikoku Cancer Center
RECRUITING

Matsuyama, 791-0280, Japan
New Cross Hospital - The Royal Wolverhampton NHS Trust
RECRUITING

Wolverhampton, WV10 0QP, United Kingdom
New England Cancer Specialists
RECRUITING

Westbrook, Maine, 04092, United States
North Wales Cancer Treatment C - Glan Clwyd Hospital
RECRUITING

Rhyl, LL18 5UJ, United Kingdom
Northwest Medical Specialties, PLLC
RECRUITING

Tacoma, Washington, 98405, United States
Oncology Consultants PA
RECRUITING

Houston, Texas, 77024, United States
Oncology Consultants PA
RECRUITING

Houston, Texas, 77030, United States
Oncology Hematology West, PC dba Nebraska Cancer Specialist
RECRUITING

Grand Island, Nebraska, 68803, United States
Oncology Specialists of Charlotte Pa
RECRUITING

Charlotte, North Carolina, 28204, United States
OneR The Center For Cancer And Blood Disorders (Texas Cancer Care)
RECRUITING

Arlington, Texas, 76104, United States
OneR The Center For Cancer And Blood Disorders (Texas Cancer Care)
RECRUITING

Burleson, Texas, 76028, United States
OneR The Center For Cancer And Blood Disorders (Texas Cancer Care)
RECRUITING

Fort Worth, Texas, 76104, United States
OneR The Center For Cancer And Blood Disorders (Texas Cancer Care)
RECRUITING

Weatherford, Texas, 76068, United States
Onkologisch-Haematologische Schwerpunktpraxis
RECRUITING

Bremen, 28209, Germany
Oregon Oncology Specialists
RECRUITING

Salem, Oregon, 97301, United States
Paradigm New York Cancer and Blood Specialists
RECRUITING

Bay Shore, New York, 11706, United States
Paradigm New York Cancer and Blood Specialists
RECRUITING

New York, New York, 10028, United States
Paradigm New York Cancer and Blood Specialists
RECRUITING

New York, New York, 10469, United States
Paradigm New York Cancer and Blood Specialists
RECRUITING

New York, New York, 11042, United States
Paradigm New York Cancer and Blood Specialists
RECRUITING

New York, New York, 11210, United States
Paradigm New York Cancer and Blood Specialists
RECRUITING

New York, New York, 11702, United States
Paradigm New York Cancer and Blood Specialists
RECRUITING

New York, New York, 11772, United States
Paradigm New York Cancer and Blood Specialists
RECRUITING

New York, New York, 11776, United States
Paradigm New York Cancer and Blood Specialists
RECRUITING

New York, New York, 11901, United States
Paradigm Oncology Hematology West P.C. dba Nebraska Cancer Specialists
RECRUITING

Omaha, Nebraska, 68310, United States
Parc de Salut Mar - Hospital del Mar
RECRUITING

Barcelona, 8003, Spain
Peninsula & South Eastern Hematology and Oncology Group
RECRUITING

Frankston, Victoria, 3199, Australia
Perola Centro de Pesquisa em Oncologia
RECRUITING

São Paulo, 01317-001, Brazil
Peter MacCallum Cancer Centre
RECRUITING

Melbourne, Victoria, 3000, Australia
Praxis Fuer Interdisziplinaere Onkologie & Haematologie
RECRUITING

Freiburg im Breisgau, 79106, Germany
Profound Research LLC at Michigan Hematology and Oncology Consultants
RECRUITING

Royal Oak, Michigan, 48073, United States
Rochester General Hospital Lipson Cancer Institute
RECRUITING

Rochester, New York, 14621, United States
Royal Stoke University Hospital - University Hospitals of North Midlands NHS Trust
RECRUITING

Stoke-on-Trent, ST4 6QG, United Kingdom
Royal Sussex County Hospital - University Hospitals Sussex NHS Foundation Trust
RECRUITING

Brighton, BN2 5BE, United Kingdom
Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey)
RECRUITING

Livingston, New Jersey, 07039, United States
Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey)
RECRUITING

Long Branch, New Jersey, 07740, United States
Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey)
RECRUITING

New Brunswick, New Jersey, 08901, United States
Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey)
RECRUITING

Newark, New Jersey, 07112, United States
Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey)
RECRUITING

Somerville, New Jersey, 08876, United States
Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey)
RECRUITING

Toms River, New Jersey, 08755, United States
SRH Wald-Kliniken Gera GmbH
RECRUITING

Gera, 07548, Germany
Sacred Heart Medical Oncology Group
RECRUITING

Pensacola, Florida, 32504, United States
Saint Agnes Hospital, Clinical Research Center
RECRUITING

Baltimore, Maryland, 21229, United States
Saint Luke's Hospital of Kansas City
RECRUITING

Kansas City, Missouri, 64111, United States
Samsung Medical Center
RECRUITING

Seoul, 6351, South Korea
Sarah Cannon Research Institute
RECRUITING

London, W1G 6AD, United Kingdom
Seoul National University Bundang Hospital (SNUBH)
RECRUITING

Seongnam-si, 13620, South Korea
Severance Hospital, Yonsei University Health System
RECRUITING

Seoul, 3722, South Korea
Shandong Cancer Hospital And Institute
RECRUITING

Jinan, 250117, China
Soon Chun Hyang University Cheonan Hospital
RECRUITING

Cheonan, 31151, South Korea
Southampton General Hospital - University Hospital Southampton NHS Foundation Trust
RECRUITING

Southampton, SO16 6YD, United Kingdom
St Bartholomew's Hospital - Barts Health NHS Trust
RECRUITING

London, EC1A 7BE, United Kingdom
St Charles Bend Cancer Center
RECRUITING

Bend, Oregon, 97701, United States
St James's University Hospital - Leeds Teaching Hospitals NHS Trust
RECRUITING

Leeds, LS9 7TF, United Kingdom
St Vincent's Hospital - The Kinghorn Cancer Centre
RECRUITING

Darlinghurst, New South Wales, 2010, Australia
St. Charles Cancer Center - Redmond
RECRUITING

Redmond, Oregon, 97756, United States
Stanford University School of Medicine - Stanford Cancer Institute (SCI) - Stanford Women's Cancer Center
RECRUITING

Palo Alto, California, 94304-2201, United States
Stony Brook University Medical Center
RECRUITING

Stony Brook, New York, 11794, United States
Summit Medical Group PA
RECRUITING

Florham Park, New Jersey, 07932, United States
The First Affiliated Hospital of Zhengzhou University
RECRUITING

Zhengzhou, 450052, China
The Royal Free Hospital - Royal Free London NHS Foundation Trust
RECRUITING

London, NW3 2QG, United Kingdom
The West Clinic, P.C. dba West Cancer Center
RECRUITING

Germantown, Tennessee, 38002, United States
Tohoku University Hospital
RECRUITING

Sendai, 980-8574, Japan
Torbay Hosptial, South Devon Healthcare NHS Foundation Trust
RECRUITING

Torquay, TQ2 7AA, United Kingdom
UT Southwestern Medical Center at Redbird
RECRUITING

Dallas, Texas, 75237, United States
UT Southwestern Medical Center at Richardson/Plano
RECRUITING

Richardson, Texas, 75080, United States
UT Southwestern Moncrief Cancer Institute
RECRUITING

Fort Worth, Texas, 76104, United States
Unidade de Pesquisa Clinica em Oncologia Ltda (UPCO) (Clinica Lacks)
RECRUITING

Pelotas, 96020-080, Brazil
Universidad de Navarra - Clinica Universidad de Navarra (CUN)
RECRUITING

Madrid, 28027, Spain
Universidad de Navarra - Clínica Universidad de Navarra (CUN)
RECRUITING

Pamplona, 31008, Spain
Universitair Ziekenhuis Brussel (AZ-VUB - Academisch Ziekenhuis der Vrije Universiteit Brussel)
RECRUITING

Brussels, 1090, Belgium
Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc
RECRUITING

Woluwe-Saint-Lambert, 1200, Belgium
University College London Hospitals NHS Foundation Trust
RECRUITING

London, NW2 1PG, United Kingdom
University Hospitals Bristol and Weston NHS Foundation Trust, Bristol Haematology & Oncology Centre
RECRUITING

Bristol, BS2 8ED, United Kingdom
University Hospitals Leuven
RECRUITING

Leuven, 3000, Belgium
University Medical Center, Inc. DBA University of Louisville Hospital/James Graham Brown Cancer Center
RECRUITING

Louisville, Kentucky, 40202, United States
University Of California - San Diego Moores Cancer Center
RECRUITING

La Jolla, California, 92037, United States
University Of Texas Southwestern Medical Center
RECRUITING

Dallas, Texas, 75390, United States
Uniwersyteckie Centrum Kliniczne
RECRUITING

Gdansk, 80-214, Poland
Westmead Hospital
RECRUITING

Westmead, 2145, Australia
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
RECRUITING

Warsaw, 04-141, Poland

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