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BNTXBioNTech SERunning, no new patients

Safety and Preliminary Effectiveness of BNT327, an Investigational Therapy for Breast Cancer, When Given in Combination With Chemotherapy

Locally Advanced Breast Cancer · Triple Negative Breast Cancer · Metastatic Triple Negative Breast Cancers

0Calmworry score, out of 100

No strong warning signs right now. The score counts warning signs; it is not a prediction.

Why this score

No warning signs right now. That's why the score is 0.

Score over time

Stage
Phase 2
Patients
83 (final count)
Started
Aug 26, 2024
Main results expected
Aug 2028
Fully finished
Jun 2029
Results posted
not yet

What counts as success

The trial's main goal(s), called the “primary outcome.”

  • Occurrence of treatment emergent adverse events (TEAEs), adverse events of special interest (AESIs), treatment emergent serious adverse events (SAEs)

    Measured over: up to 100 days after the last dose of treatment

  • Occurrence of dose interruption, dose reduction, and discontinuation of study treatment due to adverse events (AEs)

    Measured over: up to 100 days after the last dose of treatment

  • Objective Response Rate (ORR)

    Measured over: Until end-of-treatment visit, i.e., up to 24 months after the first dose of treatment

  • Best percentage change from baseline in the tumor size

    Measured over: Until end-of-treatment visit, i.e., up to 24 months after the first dose of treatment

  • Proportion of participants who have achieved early tumor shrinkage

    Measured over: up to 4 months after first dose of treatment

Changes Tremor has spotted

No changes since Tremor started watching this trial.
Show details (technical version)

Score inputs

  • none

Raw record changes

  • none yet

Trial ID NCT06449222 · record last updated 2026-06-30 · checked 2026-11-09 15:47 UTC

See the official record on ClinicalTrials.gov (NCT06449222) ↗