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Page last updated: 11/17/2020

A phase 2, single-arm study evaluating bintrafusp alfa for the treatment of patients with metastatic triple-negative breast cancer (TNBC) that has high expression of HMGA2.*




ClinicalTrials.gov: NCT04489940

Locations: Europe and the United States


Now Enrolling

Key inclusion criteria

  • Participants must have histologically or cytologically confirmed TNBC with HMGA2-high* tumor expression and an ECOG PS of 0 or 1. Participants must have received prior systemic therapy for metastatic disease and experienced disease progression immediately prior to study entry

Key exclusion criteria

  • Participants must not have received prior cancer treatment with any immunotherapy, immune checkpoint inhibitor, or immune-modulating monoclonal antibody

Study design | Europe and the United States

ClinicalTrials.gov. Bintrafusp alfa in high mobility group AT-hook 2 (HMGA2) expressing triple negative breast cancer. https://clinicaltrials.gov/ct2/show/NCT04489940. Accessed November 17, 2020.



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Speak with a doctor before making a decision regarding whether a clinical trial is the right option.



Bintrafusp alfa is being investigated in this clinical trial. This means that it has not been shown to be safe or effective for any purpose or disease. This page describes one of the clinical trials for bintrafusp alfa, and it includes information about how the safety and efficacy of bintrafusp alfa will be measured and evaluated. Therefore, it is important to understand that bintrafusp alfa is not a treatment or therapy for cancer or any other disease, and it has not been approved to be used by any health authority, such as the European Medicines Agency or the US Food and Drug Administration, and there is no guarantee that bintrafusp alfa will be approved in the sought-after indication by any health authority worldwide.

Patients should speak with their doctors, who can help determine if a clinical trial might be the right option. Doctors will be able to answer patients' questions about the risk of participating in a trial, and what other options may be available to you.

*HMGA2-high tumor expression will be determined by a centralized RT-PCR test.
†For a full list of inclusion and exclusion criteria, please visit www.clinicaltrials.gov.
‡Until confirmed progression, unacceptable toxicity, study withdrawal, or death.
DOR, duration of response; DRR, durable response rate; ECOG PS, Eastern Cooperative Oncology Group performance status; HMGA2, high mobility group AT-hook 2; IV, intravenous; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; Q2W, every 2 weeks; RT-PCR, reverse transcriptase-polymerase chain reaction; TNBC, triple-negative breast cancer.


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