Breast cancer early detection - breast milk (BRACELET-BM1): a feasibility study
Early detection of breast cancer in women who are breastfeeding.
Breast cancer early detection - study to define preliminary sensitivity of cfDNA from breast milk in women with breast cancer and determine the feasibility of collecting and analysing paired breast milk and blood samples for breast cancer early detection in the general population and those at very high risk (VHR) for breast cancer. VHR women are those with a 30% or greater chance of developing breast cancer in their lifetime, for example, BRCA carriers. Participants 40 lactating women: • ≥14 days postpartum • General-population level BC risk (25 women), VHR for BC (10 women) or with a history or diagnosis of breast cancer (5 women) Study Intervention and/or Procedures Overall protocol process: • Advertisement placed at St Mary’s Hospital antenatal department and local breastfeeding groups through social media • Women VHR or with a history/diagnosis of breast cancer will be identified by clinical staff at local Family History Clinics (the Nightingale Centre) • Information on study given • If happy to participate they will give written consent, undergo BM collection and answer a brief questionnaire following regarding the acceptability of the procedure. • Data collection at baseline (age, previous BC and pathology details, date of collection, age of baby, number of previous children, any breast abnormalities noticed and details of related referrals, comorbidities) and confirmation of BC risk using Tyrer-Cuzick model. • Breast milk collected using a provided hospital grade breast pump (aiming for at least 20ml – approximately four teaspoons) and paired blood sample taken (10ml - approx. two teaspoon). • Questionnaire and structured interview will be conducted by Dr Niki Flaum or a trained Research Practitioner. The interviews will be recorded at St Mary’s Hospital or the Nightingale Centre at Wythenshawe Hospital at the study visit on a University of Manchester-approved Dictaphone and transcribed using a University-approved transcription service (1st Class Secret
1. Women breastfeeding/expressing breast milk 2. ≥14 days postpartum 3. General-population level BC risk, very high risk (VHR) for BC or with a history or diagnosis of breast cancer
1. Refusal or inability to give informed consent 2. Any acute or chronic condition that would limit the ability of the participant to take part in the study