Safety and Preliminary Effectiveness of BNT327, an Investigational Therapy for Breast Cancer, When Given in Combination With Chemotherapy
← catalyst calendarNCT06449222 · readout ≤ 743 d
Sponsored by BioNTech SE (industry) · BNTX — their whole pipeline →. With Bristol-Myers Squibb.
Phase
Phase 2
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
83actual
Sites
31
Countries
Australia, Turkey (Türkiye), United Kingdom +1
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-08-26 | actual | When the study began enrolling |
| Primary completion | Aug 2028 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Jun 2029 | estimated | The whole study's end, after follow-up |
| First posted | 2024-06-07 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-30 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Locally Advanced Breast Cancer
- Triple Negative Breast Cancer
- Metastatic Triple Negative Breast Cancers
Interventions
- Drug: BNT327 Dose Level 1 (DL1)
- Drug: BNT327 Dose Level 1 (DL2)
- Drug: Nab-placlitaxel
- Drug: Carboplatin
- Drug: Gemcitabine
- Drug: Paclitaxel
- Drug: Eribulin
- Drug: BNT327 Optimized Dose
- Drug: BNT327 Equivalent Q3W Dose
Primary outcomes
what the primary-completion date above is the date OFOccurrence of treatment emergent adverse events (TEAEs), adverse events of special interest (AESIs), treatment emergent serious adverse events (SAEs)
measured 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 up to 100 days after the last dose of treatment
Objective Response Rate (ORR)
measured 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 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 up to 4 months after first dose of treatment
Publications
- PMID 40970572 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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