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A Clinical Study to Find the Optimal Dose of an Investigational Treatment Called BNT323 When Used in Combination With Another Investigational Treatment, BNT327, and to Test if That Combination Treatment is Safe and Beneficial for Patients With Advanced Breast Cancer

A study testing new treatments for advanced breast cancer safety.

Recruiting
18 years and older
All
Phase 1/2

This study is testing two investigational treatments, BNT323 and BNT327, to find the best dose for treating advanced breast cancer. The study has two parts. In Part 1, doctors will try different doses to find the right amount. In Part 2, they will test the best dose combination to see how well it works. Breast cancer types being studied include hormone receptor-positive, HER2-positive, HER2-low, HER2-ultralow, and triple-negative.

  • This study is for people with advanced, difficult-to-treat breast cancer.
  • Participants will be closely monitored to ensure their safety.
  • Those taking part may receive either the combination therapy or one of the drugs alone.

To join, participants must have measurable disease (cancer that can be measured by doctors) and a heart function test showing a certain level of health. People with certain health issues or who have taken specific medications recently may not be eligible. The study is conducted across multiple sites, so participants will need to visit a study location for treatments and check-ups. Being part of this study could help in finding better treatments for breast cancer.

Study details
    Locally Advanced Breast Cancer
    Unresectable Breast Carcinoma
    Metastatic Breast Cancer

NCT06827236

BioNTech SE

7 March 2026

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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