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 Nov 01, 2025 · Last updated Jun 23, 2026 · Updated 29 times

Summary

This Phase 3 trial tests whether adding the experimental drug BNT327 to standard chemotherapy helps people with advanced triple-negative breast cancer that cannot be treated with current immunotherapy. About 558 participants will be randomly assigned to receive either BNT327 plus chemo or a placebo plus chemo. The study is double-blind, meaning neither patients nor doctors know who gets the real drug. The main goals are to see if the combination slows cancer growth and improves overall survival.

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This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Contacts and locations

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Study contacts

Contact

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Locations

Ajou University Hospital
RECRUITING

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

Seoul, 5505, South Korea
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I
RECRUITING

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

Lucca, 55100, Italy
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
RECRUITING

Urbana, Illinois, 61801, United States
Caucasus Medical Centre
RECRUITING

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

Los Angeles, California, 90048, United States
Centro di Riferimento Oncologico (CRO)
RECRUITING

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 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
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
RECRUITING

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
RECRUITING

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
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
Karmanos Cancer Center
RECRUITING

Detroit, Michigan, 48201, United States
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
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
Oregon Oncology Specialists
RECRUITING

Salem, Oregon, 97301, 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
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
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 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
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
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
Westmead Hospital
RECRUITING

Westmead, 2145, Australia

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 an early-stage Phase 3 trial, so results are not yet known. The drug may not work better than placebo, and side effects from the combination could be significant.

Conditions

The condition(s) this trial relates to.

breast neoplasm

As listed by the trial registrant

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

BREAST NEOPLASMS BREAST NEOPLASMS