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BioNTech clinical trials patient information +49 6131 9084
patients@biontech.de


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Be Part of Research - Trial Details - Safety and Preliminary Effectiveness of BNT327, an Investigational Therapy for Breast Cancer, When Given in Combination With Chemotherapy

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

Recruiting

Open to: ALL

Age: 18.0 - N/A

Medical Conditions

Breast Neoplasms
Triple Negative Breast Neoplasms


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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).

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Aug 2024 Nov 2027

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Intravenous (IV) infusion

Intervention Arm Group : Cohort 1 Arm 1 - BNT327 DL1 + Nab-paclitaxel;

Intervention Type : DRUG
Intervention Description : IV infusion

Intervention Arm Group : Cohort 1 Arm 2 - BNT327 DL2 + Nab-paclitaxel;

Intervention Type : DRUG
Intervention Description : IV infusion

Intervention Arm Group : Cohort 1 Arm 1 - BNT327 DL1 + Nab-paclitaxel;Cohort 1 Arm 2 - BNT327 DL2 + Nab-paclitaxel;

Intervention Type : DRUG
Intervention Description : IV infusion

Intervention Arm Group : Cohort 2 Arm 2 - BNT327 Equivalent Q3W dose + Gemcitabine + Carboplatin;

Intervention Type : DRUG
Intervention Description : IV infusion

Intervention Arm Group : Cohort 2 Arm 2 - BNT327 Equivalent Q3W dose + Gemcitabine + Carboplatin;

Intervention Type : DRUG
Intervention Description : IV infusion

Intervention Arm Group : Cohort 2 Arm 1 - BNT327 Optimized dose + Paclitaxel;

Intervention Type : DRUG
Intervention Description : IV infusion

Intervention Arm Group : Cohort 2 Arm 3 - BNT327 Equivalent Q3W dose + Eribulin;

Intervention Type : DRUG
Intervention Description : IV infusion

Intervention Arm Group : Cohort 2 Arm 1 - BNT327 Optimized dose + Paclitaxel;

Intervention Type : DRUG
Intervention Description : IV infusion

Intervention Arm Group : Cohort 2 Arm 2 - BNT327 Equivalent Q3W dose + Gemcitabine + Carboplatin;Cohort 2 Arm 3 - BNT327 Equivalent Q3W dose + Eribulin;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Nottingham University Hospitals Nhs Trust
    Nottingham
    NG5 1PB
  • University College London Hospitals NHS Foundation Trust
    London
    NW2 1PG
  • Sarah Cannon Research Institute
    London
    W1G 6AD
  • St Bartholomew's Hospital - Barts Health NHS Trust
    London
    EC1A 7BE
  • Hull and East Yorkshire Hospitals NHS Trust - Castle Hill Hospital
    Cottingham
    HU16 5JQ
  • Royal Cornwall Hospital - Royal Cornwall Hospitals NHS Trust
    Truro
    TR1 3LJ
  • Stoke Mandeville Hospital - Buckinghamshire Healthcare NHS Trust
    Aylesbury
    HP21 8AL
  • University Hospital Coventry - University Hospitals Coventry and Warwickshire NHS Trust
    Coventry
    CV2 2DX
  • Edinburgh Cancer Centre-Western General Hospital
    Edinburgh
    EH4 2LF
  • St James's University Hospital - Leeds Teaching Hospitals NHS Trust
    Leeds
    LS9 7TF

BioNTech clinical trials patient information +49 6131 9084
patients@biontech.de



The study is sponsored by BioNTech SE





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Read full details for Trial ID: NCT06449222
Last updated 01 May 2025

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