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RecruitingNCT07135960Updated Sep 17, 2026

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

An observational study in Breast Cancer Patients, sponsored by Portsmouth Hospitals NHS Trust. Recruiting at 1 site in United Kingdom. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-17.

Sponsored by Portsmouth Hospitals NHS Trust · Observational

From the registry’s dates

  • Started Feb 2025; still recruiting 1 year 9 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
45
Ages
18 Years and older
Sex
Female
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Study 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.

Read the detailed description

Breast cancer is an increasingly common condition, affecting >56,000 women a year in the UK. Surgery and radiotherapy are commonly used to treat breast cancer. Both these treatments can affect the structure and movement of the breast tissue, which is collectively called breast biomechanics. Breast biomechanics has been studied in healthy women and in female athletes, and across the menstrual cycle, menopause and pregnancy. Investigators know from this research that breast biomechanics can affect the type of bra support women need, which when optimised can improve comfort and quality of life as well as reduce the potential for tissue damage. However, breast biomechanics and associated breast garment support requirements (bra support) have not yet been significantly investigated in women undergoing breast cancer treatment.

Patients who would be eligible to participate in this study include women aged 18 or treated with surgery +/- radiotherapy for breast cancer that affects one of their breasts. Patients will be recruited from the Breast Unit at Queen Alexandra Hospital, Cosham. Participation in this study will involve attending the biomechanics testing laboratory at UoP after their surgery and/or after radiotherapy, and optionally before surgery too. 3D scans and sensors will be used to assess the structure and movement of the breast. Participants will be asked their views on the testing methods, as well as their bra requirements and exercise habits before and after breast cancer treatment. The information generated from this study could be used in the future to help design better bras for women treated for breast cancer. It could also help women make decisions about treatment based on evidence about how the breast is likely to move differently afterwards and improve satisfaction with treatment outcomes.

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Conditions studied

  • Breast Cancer Patients

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03

In context

Breast Neoplasms

14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.

This study's planned enrollment of 45 is below the median of 184 across 3,235 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Portsmouth Hospitals NHS Trust is the lead sponsor of 74 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Female
  • 18 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
  • +/- radiotherapy
  • Able to travel to the University of Portsmouth Breast biomechanics laboratory
  • Participant has capacity to consent.

Exclusion criteria

Exclusion Criteria:

  • 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
45 participants (estimated)
Patient registry
No

Groups and cohorts

  • Participants with relevant condition
  • Women aged 18 or treated with surgery +/- radiotherapy for breast cancer that affects one of their b
06

What researchers measure

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

    Time frame: 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.

    To collect quantitative data on breast biomechanics. To assess: Sensitivity of data collection methods to detect differences in breast biomechanics pre-operatively to post-operatively and/or between left breast and right breast.

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

07

Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07135960
Lead sponsor
Portsmouth Hospitals NHS Trust
Collaborators
University of Portsmouth
Responsible party
Sponsor
First posted
Aug 22, 2025
Start date
Feb 6, 2025
Primary completion
Jan 28, 2027 (estimated)
Completion
Jan 28, 2027 (estimated)
Last update
Sep 17, 2026

Study contacts

Amy Huseyin
Contact
Amyrose.Huseyin@porthosp.nhs.uk
02392 286000
Edward St John
principal investigator · Portsmouth Hospitals NHS Trust

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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