BNT327-05
Research type
Research Study
Full title
A Phase III, multisite, randomized, double-blind trial of BNT327 in combination with chemotherapy versus placebo with chemotherapy in patients with previously untreated locally recurrent inoperable or metastatic TNBC determined ineligible for PD(L)1 therapy based on PD-L1 negative disease.
IRAS ID
1012205
Contact name
Alexandra Piotrowska
Contact email
Sponsor organisation
BioNTech SE
Research summary
This study aims to understand the effects of BNT327 (aka Pumitamig) with chemotherapy compared to a placebo. A placebo looks like the study drug but does not contain any active medicine. Patients can participate if they have a form of breast cancer known as Triple Negative Breast Cancer which has returned and is not able to be surgically removed or has spread to another part of the body. Participants are randomly assigned to 1 of 2 groups: 1) BNT327 with chemotherapy or 2) placebo with chemotherapy. This study is double blinded, which means the study team and the participant will not know whether they are receiving BNT327 or the placebo. The dosage of BNT327 a participant receives will depend on their weight. There are 3 parts to this study. First, the Screening period; participants will sign the consent form and provide their medical history. The Screening period is to determine if a patient is eligible to participate. If successful, the participant will enter the Treatment period. The Treatment period consists of 21 or 28 day cycles. This depends on the type of chemotherapy received. BNT327 or the placebo, will be given to the participant on Day 1 of the 21 day cycle and Day 1 and 15 of the 28 day cycle. The participant will also receive chemotherapy during this time. The days on which chemotherapy is given, depends on the type of chemotherapy received. This will be decided by the study doctor. Participants will also be asked to provide blood samples, undergo scans, and complete questionnaires about their wellbeing and symptoms. The treatment period will last up to 2 years. The Follow-up period is the last part of the study. There will be a follow up visit 30 and 90 days after the participants receives the last dose of the study drug. On these visits, participants will be asked to provide information on their symptoms, wellbeing, and some blood tests. After this, there will be follow ups every 12 weeks, to check participants health, symptoms and wellbeing.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
25/NE/0222
Date of REC Opinion
22 Jan 2026
REC opinion
Further Information Favourable Opinion