Triple-Negative Breast Cancer Clinical Trials

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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

Status: Recruiting
Location: See all (103) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Arkansas
Highlands Oncology Group
RECRUITING
Springdale
California
University Of California - San Diego Moores Cancer Center
RECRUITING
La Jolla
Cedar Sinai - Samuel Oschin Cancer Center
RECRUITING
Los Angeles
Stanford University School of Medicine - Stanford Cancer Institute (SCI) - Stanford Women's Cancer Center
RECRUITING
Palo Alto
Florida
Sacred Heart Medical Oncology Group
RECRUITING
Pensacola
Illinois
Cancer Care Specialists
RECRUITING
Decatur
Cancer Care Specialists of Illinois
RECRUITING
O'fallon
Carle Foundation Hospital d/b/a Carle Cancer Center
RECRUITING
Urbana
Kentucky
University Medical Center, Inc. DBA University of Louisville Hospital/James Graham Brown Cancer Center
RECRUITING
Louisville
Massachusetts
Lahey Hospital & Medical Center
RECRUITING
Burlington
Maryland
Saint Agnes Hospital, Clinical Research Center
RECRUITING
Baltimore
Maine
New England Cancer Specialists
RECRUITING
Westbrook
Michigan
Karmanos Cancer Center
RECRUITING
Detroit
Profound Research LLC at Michigan Hematology and Oncology Consultants
RECRUITING
Royal Oak
Missouri
Saint Luke's Hospital of Kansas City
RECRUITING
Kansas City
Nebraska
Oncology Hematology West, PC dba Nebraska Cancer Specialist
RECRUITING
Grand Island
Paradigm Oncology Hematology West P.C. dba Nebraska Cancer Specialists
RECRUITING
Omaha
New Jersey
Summit Medical Group PA
RECRUITING
Florham Park
New York
Rochester General Hospital Lipson Cancer Institute
RECRUITING
Rochester
Stony Brook University Medical Center
RECRUITING
Stony Brook
Montefiore Medical Center
RECRUITING
The Bronx
Oregon
Oregon Oncology Specialists
RECRUITING
Salem
Tennessee
The West Clinic, P.C. dba West Cancer Center
RECRUITING
Germantown
Texas
Oncology Consultants PA
RECRUITING
Houston
Oncology Consultants PA
RECRUITING
Houston
Washington
Northwest Medical Specialties, PLLC
RECRUITING
Tacoma
Other Locations
Australia
GenesisCare St Andrew's Precinct
RECRUITING
Adelaide
St Vincent's Hospital - The Kinghorn Cancer Centre
RECRUITING
Darlinghurst
Peninsula & South Eastern Hematology and Oncology Group
RECRUITING
Frankston
Monash University - Monash Medical Centre (MMC) - Clayton
RECRUITING
Melbourne
Peter MacCallum Cancer Centre
RECRUITING
Melbourne
Westmead Hospital
RECRUITING
Westmead
Belgium
Universitair Ziekenhuis Brussel (AZ-VUB - Academisch Ziekenhuis der Vrije Universiteit Brussel)
RECRUITING
Brussels
Grand hospital de Charleroi
RECRUITING
Gilly
University Hospitals Leuven
RECRUITING
Leuven
Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc
RECRUITING
Woluwe-saint-lambert
China
Changde First People's Hospital
RECRUITING
Changde
Shandong Cancer Hospital And Institute
RECRUITING
Jinan
Fudan University - Shanghai Cancer Center (FUSCC)
RECRUITING
Shanghai
The First Affiliated Hospital of Zhengzhou University
RECRUITING
Zhengzhou
Georgia
High Technology Hospital Medcenter LTD
RECRUITING
Batumi
Caucasus Medical Centre
RECRUITING
Tbilisi
LLC Todua Clinic
RECRUITING
Tbilisi
Multiprofile Clinic Consilium Medulla
RECRUITING
Tbilisi
Germany
Hämatologische-Onkologische Praxis Augsburg
RECRUITING
Augsburg
Praxis Fuer Interdisziplinaere Onkologie & Haematologie
RECRUITING
Freiburg Im Breisgau
Institut fuer Versorgungsforschung in der Onkologie
RECRUITING
Koblenz
Italy
Centro di Riferimento Oncologico (CRO)
RECRUITING
Aviano
Azienda Unità Sanitaria Locale 2 (USL2) Lucca
RECRUITING
Lucca
Fondazione IRCCS Istituto Nazionale dei Tumori
RECRUITING
Milan
IRCCS-Istituto Europeo di Oncologia
RECRUITING
Milan
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele)
RECRUITING
Milan
Fondazione Policlinico Universitario Campus Bio-Medico
RECRUITING
Roma
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I
RECRUITING
Torrette
Japan
Chiba Cancer Center
RECRUITING
Chiba
Fukushima Medical University Hospital
RECRUITING
Fukushima
Gifu University Hospital
RECRUITING
Gifu
Hiroshima City Hiroshima Citizens Hospital
RECRUITING
Hiroshima
Kumamoto University Hospital
RECRUITING
Kumamoto
Kyoto University Hospital
RECRUITING
Kyoto
National Hospital Organization Shikoku Cancer Center
RECRUITING
Matsuyama
Nagoya City University Hospital
RECRUITING
Nagoya
Tohoku University Hospital
RECRUITING
Sendai
National Center For Global Health And Medicine
RECRUITING
Shinjuku-ku
Poland
IP Clinic Sp. z o.o.
RECRUITING
Lodz
Narodowy Insytut Onkologii im. Marii Sklodowskiej-Curie - Państwowy Instytut Badawczy
RECRUITING
Warsaw
Republic of Korea
Soon Chun Hyang University Cheonan Hospital
RECRUITING
Cheonan
Chungbuk National University Hospital
RECRUITING
Cheongju-si
National Cancer Center
RECRUITING
Goyang-si
Seoul National University Bundang Hospital (SNUBH)
RECRUITING
Seongnam-si
Asan Medical Center (AMC)
RECRUITING
Seoul
Korea University Anam Hospital
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System
RECRUITING
Seoul
Ajou University Hospital
RECRUITING
Suwon
Spain
Hospital Universitario de Badajoz
RECRUITING
Badajoz
Institut Oncologic Rosell - Hospital General De Catalunya
RECRUITING
Barcelona
Parc de Salut Mar - Hospital del Mar
RECRUITING
Barcelona
Hospital Universitario Reina Sofia
RECRUITING
Córdoba
Hospital Universitario Fundación Jiménez Díaz
RECRUITING
Madrid
Hospital Universitario Madrid Sanchinarro - Centro Integral Oncologico Clara Campal (CIOCC)
RECRUITING
Madrid
IOB Institute of Oncology - Beata Maria Ana Hospital
RECRUITING
Madrid
Universidad de Navarra - Clinica Universidad de Navarra (CUN)
RECRUITING
Madrid
Hospital General Universitario Morales Meseguer
RECRUITING
Murcia
Hospital Universitario Virgen De La Arrixaca (Huva)
RECRUITING
Murcia
Universidad de Navarra - Clínica Universidad de Navarra (CUN)
RECRUITING
Pamplona
Hospital Universitari Parc Tauli
RECRUITING
Sabadell
Fundación Instituto Valenciano de Oncología
RECRUITING
Valencia
United Kingdom
Royal Sussex County Hospital - University Hospitals Sussex NHS Foundation Trust
RECRUITING
Brighton
University Hospitals Bristol and Weston NHS Foundation Trust, Bristol Haematology & Oncology Centre
RECRUITING
Bristol
Hull and East Yorkshire Hospitals NHS Trust - Castle Hill Hospital
RECRUITING
Cottingham
Edinburgh Cancer Centre-Western General Hospital
RECRUITING
Edinburgh
St James's University Hospital - Leeds Teaching Hospitals NHS Trust
RECRUITING
Leeds
Sarah Cannon Research Institute
RECRUITING
London
St Bartholomew's Hospital - Barts Health NHS Trust
RECRUITING
London
The Royal Free Hospital - Royal Free London NHS Foundation Trust
RECRUITING
London
University College London Hospitals NHS Foundation Trust
RECRUITING
London
Churchill Hospital - Oxford University Hospitals NHS Foundation Trust
RECRUITING
Oxford
North Wales Cancer Treatment C - Glan Clwyd Hospital
RECRUITING
Rhyl
Southampton General Hospital - University Hospital Southampton NHS Foundation Trust
RECRUITING
Southampton
Royal Stoke University Hospital - University Hospitals of North Midlands NHS Trust
RECRUITING
Stoke-on-trent
Torbay Hosptial, South Devon Healthcare NHS Foundation Trust
RECRUITING
Torquay
New Cross Hospital - The Royal Wolverhampton NHS Trust
RECRUITING
Wolverhampton
Contact Information
Primary
BioNTech clinical trials patient information
patients@biontech.de
+49 6131 9084
Time Frame
Start Date: 2025-10-30
Estimated Completion Date: 2030-09
Participants
Target number of participants: 558
Treatments
Experimental: Arm 1: Pumitamig + Treatment of Physician's Choice (TPC) Chemotherapy
Participants will be administered with pumitamig (BNT327) plus chemotherapy regimen.
Placebo_comparator: Arm 2: Placebo + TPC Chemotherapy
Participants will be administered with matching placebo plus chemotherapy regimen.
Sponsors
Collaborators: Bristol-Myers Squibb
Leads: BioNTech SE

This content was sourced from clinicaltrials.gov