ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer

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.

Trial Details

NCT ID
NCT07173751
Phase
PHASE3
Sponsor
BioNTech SE
Status
RECRUITING
Cancer Type
Triple Negative (TNBC) Breast Cancer
Interventions
  • Pumitamig
  • Nab-paclitaxel/Paclitaxel
  • Gemcitabine
  • Carboplatin
  • Eribulin
  • Matching placebo
Locations (sample)
  • Springdale, Arkansas, United States|36.18674,-94.12881
  • La Jolla, California, United States|32.84727,-117.2742
  • Los Angeles, California, United States|34.05223,-118.24368
  • Palo Alto, California, United States|37.44188,-122.14302
  • Pensacola, Florida, United States|30.42131,-87.21691

Key Eligibility Criteria

  • Are considered ineligible for combination treatment with a monospecific PD(L)1 targeting immunotherapy plus chemotherapy as per their tumor PD-L1 e…
  • Have confirmed locally recurrent inoperable or metastatic TNBC, or estrogen receptor (ER)-low, human epidermal growth factor receptor 2 (HER2)-nega…
  • 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 ple…

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

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