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 (28) 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
Stanford University School of Medicine - Stanford Cancer Institute (SCI) - Stanford Women's Cancer Center
RECRUITING
Palo Alto
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
Massachusetts
Lahey Hospital & Medical Center
RECRUITING
Burlington
Maine
New England Cancer Specialists
RECRUITING
Westbrook
Michigan
Profound Research LLC at Michigan Hematology and Oncology Consultants
RECRUITING
Royal Oak
Nebraska
Paradigm Oncology Hematology West P.C. dba Nebraska Cancer Specialists
RECRUITING
Omaha
New York
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
Peninsula & South Eastern Hematology and Oncology Group
RECRUITING
Frankston
China
Fudan University - Shanghai Cancer Center (FUSCC)
RECRUITING
Shanghai
Georgia
High Technology Hospital Medcenter LTD
RECRUITING
Batumi
Caucasus Medical Centre
RECRUITING
Tbilisi
LLC Todua Clinic
RECRUITING
Tbilisi
Republic of Korea
Chungbuk National University Hospital
RECRUITING
Cheongju-si
Korea University Anam Hospital
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System
RECRUITING
Seoul
United Kingdom
Edinburgh Cancer Centre-Western General Hospital
RECRUITING
Edinburgh
Sarah Cannon Research Institute
RECRUITING
London
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.