This study is a Phase II, multi-site, randomized, open-label clinical study to evaluate the safety, efficacy, and pharmacokinetics (PK) of BNT327 at two dose levels in combination with chemotherapeutic agents in the first- and second-line treatment of participants with locally advanced/metastatic triple-negative breast cancer (mTNBC).
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Occurrence of treatment emergent adverse events (TEAEs), adverse events of special interest (AESIs), treatment emergent serious adverse events (SAEs)
Timeframe: 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)
Timeframe: up to 100 days after the last dose of treatment
Objective Response Rate (ORR)
Timeframe: 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
Timeframe: 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
Timeframe: up to 4 months after first dose of treatment