BRACELET_BM1: v1.1
Research type
Research Study
Full title
BREAST CANCER EARLY DETECTION - BREAST MILK (BRACELET-BM1): A FEASIBILITY STUDY
IRAS ID
341900
Contact name
Niki Flaum
Contact email
Sponsor organisation
University of Manchester
Duration of Study in the UK
1 years, 7 months, 21 days
Research summary
This study BRACELET-BM1 is investigating if breast milk (BM) could be used to detect breast cancer that occurs during/shortly after pregnancy (pregnancy-related breast cancer; PRBC). In the general population PRBC occurs in ~1/3000 pregnancies, but in women high-risk for breast cancer has been reported in up to 1/50 pregnancies. Diagnosis of PRBC is frequently at a later stage when the cancer has already spread, and survival is significantly worse than breast cancer in women the same age who have not recently had a baby. Breast imaging during pregnancy and while women are lactating is unreliable, and therefore better screening tools are needed. Recently a study was published showing breast cancer cells (circulating-tumour DNA; ctDNA) could be detected from BM, however the best way to collect and test BM for cell-free DNA (cfDNA), which has not been done before in the UK, and how this could be used in the future, still needs investigation.
We aim to collect BM and blood from 40 women who have general-population level or high risk for breast cancer. We will offer a repeat study visit 8 weeks later to 5 participants. This will allow us to find the best way to collect, test and store BM as a liquid biopsy looking for cfDNA. We also will give the women a questionnaire and interview to assess how acceptable this procedure is. Women will be recruited and invited to a study visit at St Mary’s Hospital, Manchester.
We will be able to use this established procedure to then test BM from women with breast cancer and high-risk for breast cancer in future studies to see if this can be used as a screening test.
This work is funded by Prevent Breast Cancer and Academy for Medical Sciences. For more information contact Dr Niki Flaum at Nicola.flaum@manchester.ac.uk.REC name
South Central - Oxford A Research Ethics Committee
REC reference
25/SC/0308
Date of REC Opinion
16 Sep 2025
REC opinion
Favourable Opinion