Phase 2 Breast Cancer Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You have been diagnosed with breast cancer that has spread to nearby tissues and cannot be removed by surgery, or has spread to other parts of the body.
- Your breast cancer has been tested and has a confirmed HER2 status (a protein found on some cancer cells), fitting one of these categories: HER2-low, HER2-ultralow, HER2-null, HER2-positive, or triple-negative breast cancer (TNBC).
- Your cancer can be measured on a scan, meaning doctors can track whether it is growing or shrinking during the trial.
- Your heart is pumping well enough — specifically, a heart scan taken within the 28 days before joining the trial shows your heart's pumping function is at 55% or above.
Who may not be able to join:
- You have had a blockage in your small intestine serious enough to require a hospital stay within the last 3 months.
- You have another illness that is not well controlled and could make it hard to follow the trial's requirements or put you at greater risk of side effects.
- You have a build-up of fluid around your lungs, in your abdomen, or around your heart that needed draining or other treatment within the 2 weeks before joining.
- You have had a history of non-infectious lung inflammation (called interstitial lung disease or pneumonitis) that needed steroid treatment, currently have this condition, or scans at the start of the trial cannot rule it out.
- You have previously been treated with a type of cancer drug called a topoisomerase I inhibitor — this includes certain newer targeted treatments called antibody-drug conjugates, such as trastuzumab deruxtecan (also known as Enhertu).
- You have previously been treated with the investigational drug BNT323.
- You have previously received a specific type of combination immunotherapy drug that targets both PD-L1 and VEGF at the same time (confirm with trial site if unsure whether your past treatment applies).
- You have received certain immune-stimulating or immune-suppressing medicines (such as interferon-α, interleukin-2, or methotrexate) within the past 4 weeks, or within a specific timeframe based on how long that drug stays in your body — whichever is longer.
- You have been taking steroid tablets or injections at a dose higher than 10 mg per day of prednisone (or an equivalent dose of another steroid) within the 3 weeks before starting the trial — note that short-term or inhaled steroids may be allowed (confirm with trial site).
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: BioNTech Responsible Person, BioNTech SE
Phone: +49 6131 9084
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Part 1 - Occurrence of dose limiting toxicities (DLTs); Occurrence of Treatment-emergent adverse events (TEAEs), Grade ≥3 TEAEs, serious adverse events (SAEs), treatment-related TEAEs, treatment-related Grade ≥3 TEAEs, and treatment-related SAEs; Occurrence of dose interruption, reduction, and discontinuation due to TEAEs; Part 2 - Objective response rate (ORR)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 8 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.