Breast Cancer BRAs Study (Breast Cancer Biomechanics of Radiotherapy And Surgery)

NCT07135960 | Recruiting

• 1 other identifier: PHU/2024/32
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

This study, delivered by Portsmouth Hospitals University NHS Trust in conjunction with the Research Group in Breast Health at the University of Portsmouth \[1\], aims to assess whether it is possible to test breast biomechanics in women who have had surgery with or without radiotherapy for the treatment of breast cancer.

Conditions

Breast Cancer Patients

Outcome Measures

Primary Outcomes (1)

• To determine the feasibility of recruitment to a breast biomechanics study in women treated for early breast cancer with surgery +/- adjuvant radiotherapy.

  To identify: Number of patients eligible. Number of patients approached. Number of patients who give informed consent. Number of patients who withdraw after consent before participation. Number of patients who withdraw during follow-up. Number of patients lost to follow-up. Completeness of data per participant. Barriers to participation

  From enrollment to the end of study [through study completion, an average of 1 year]

Secondary Outcomes (1)

• To determine if it is possible to obtain breast biomechanics data in women treated for early breast cancer with surgery +/- adjuvant radiotherapy.

  From enrollment to the end of study [through study completion, an average of 1 year]

Study Arms (2)

Participants with relevant condition

Women aged 18 or treated with surgery +/- radiotherapy for breast cancer that affects one of their b

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Participants biological born female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female patients, aged \>18, who have a diagnosis of early breast cancer, and are offered breast surgery +/- adjuvant radiotherapy as part of their breast cancer treatment.

You may qualify if:

• Female
• years of age or above
• Early or locally advanced breast cancer classified as B5a or B5b (radical treatment intent)
• Unilateral breast cancer (contralateral breast used as control)
• Receiving or has received breast cancer surgery
• +/- Adjuvant radiotherapy
• Able to travel to the University of Portsmouth Breast biomechanics laboratory
• Participant has capacity to consent.

You may not qualify if:

• Metastatic breast cancer diagnosis
• \< 2 weeks post-operative
• \< 4 weeks post-radiotherapy
• Active post-operative breast infection
• Requirement of ongoing breast dressings
• Previous breast surgery to contralateral breast
• Bilateral breast cancer
• Epilepsy (due to strobe on 3D scanner)
• Pregnancy or \<6 weeks post-partum
• Breastfeeding
• Rockwood Frailty score \>5 (or those unable to ambulate un-aided)
• Requiring interpreter.

Sponsors & Collaborators

• Portsmouth Hospitals NHS Trust: lead
• University of Portsmouth: collaborator

Study Sites (1)

Queen Alexandra Hospital

Portsmouth, PO6 3LY, United Kingdom

RECRUITING

Study Officials

• Edward St John

  Portsmouth Hospitals University NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy Huseyin

CONTACT

02392 286000; Amyrose.Huseyin@porthosp.nhs.uk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: August 22, 2025
• Study Start: February 6, 2025
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)