Breast Cancer PatientsNCT07135960
Breast Cancer BRAs Study (Breast Cancer Biomechanics of Radiotherapy And Surgery)
An observational study of Breast Cancer Patients, run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Patients
- How many people
- 45 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Feb 2025to 28 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
- +/- Adjuvant radiotherapy
- Able to travel to the University of Portsmouth Breast biomechanics laboratory
- Participant has capacity to consent.
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Queen Alexandra Hospital
Portsmouth, PO6 3LY
About this study
Official title: Breast Cancer BRAs Study (Breast Cancer Biomechanics of Radiotherapy And Surgery): The Effects of Breast Surgery and Radiotherapy on the Breast Biomechanics and Breast Support Requirements of Women Treated for Breast Cancer.
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.
- Conditions
- Breast Cancer Patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants with relevant condition | Not described | |
| Women aged 18 or treated with surgery +/- radiotherapy for breast cancer that affects one of their b | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: From enrollment to the end of study [through study completion, an average of 1 year]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start6 Feb 2025
- Primary completion28 Jan 2027 (estimated)
- Study completion28 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Portsmouth Hospitals NHS Trust
- Sponsor type
- Other government
- Collaborators
- University of Portsmouth
- Responsible party
- Sponsor
- Investigators
- Edward St John, Principal investigator, Portsmouth Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07135960
- Sponsor's protocol ID
- PHU/2024/32
- Status last verified
- Sep 2026
- First submitted
- 27 May 2025
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Cancer BRAs Study (Breast Cancer Biomechanics of Radiotherapy And Surgery): The Effects of Breast Surgery and Radiotherapy on the Breast Biomechanics and Breast Support Requirements of Women Treated for Breast Cancer.
- ClinicalTrials.gov ID
- NCT07135960
- Acronym / sponsor ID
- PHU/2024/32
- Conditions
- Breast Cancer Patients
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Portsmouth Hospitals NHS TrustOther government
- Collaborators
- University of Portsmouth
- Study start
- 6 Feb 2025 (actual)
- Primary completion
- 28 Jan 2027 (estimated)
- Study completion
- 28 Jan 2027 (estimated)
- First posted
- 22 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with relevant condition | – | – |
| Women aged 18 or treated with surgery +/- radiotherapy for breast cancer that affects one of their b | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (12 listed)
- Metastatic breast cancer diagnosis
- < 2 weeks post-operative
- < 4 weeks post-radiotherapy
- Active post-operative breast infection
- Requirement of ongoing breast dressings
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To determine the feasibility of recruitment to a breast biomechanics study in women treated for early breast cancer with surgery +/- adjuvant radiotherapy.
Time frame: From enrollment to the end of study [through study completion, an average of 1 year]
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
1 secondary outcome
To determine if it is possible to obtain breast biomechanics data in women treated for early breast cancer with surgery +/- adjuvant radiotherapy.
Time frame: From enrollment to the end of study [through study completion, an average of 1 year]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Edward St John principal investigator
Portsmouth Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Patients, run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amy Huseyin (02392 286000, Amyrose.Huseyin@porthosp.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the feasibility of recruitment to a breast biomechanics study in women treated for early breast cancer with surgery +/- adjuvant radiotherapy. (time frame: From enrollment to the end of study [through study completion, an average of 1 year]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.