Early-stage Breast CancerBREXINTNCT05957068
Breast Cancer Exercise Intervention Study
A study testing Exercise Programme in people with Early-stage Breast Cancer and Locally Advanced Breast Cancer, run by National Cancer Centre, Singapore at 3 sites in Singapore.
Trial summary
This is a 24-week exercise programme consisting of aerobic exercise and muscle strength training, 3 sessions per week. The first 9 sessions are supervised by physiotherapists in person, followed by 63 sessions monitored remotely (video) or supervised by trainers at ActiveSG (Sport Singapore) gyms. Read more about this study
- Who is it for?
- Ages 21 to 99 years, women only
- Conditions the study is for
- Early-stage Breast Cancer, Locally Advanced Breast Cancer
- What is being tested?
- Exercise Programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,156 participants
- Where
- 3 sitesSingapore
- Study dates
- 1 Jul 2023to 31 May 2033
- Phase
- Interventional
- 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 21 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically or cytologically proven stage 1, 2, or 3 breast cancer
- Patients who have undergone curative breast surgery
- Patients who have received (neo)adjuvant chemotherapy (if given) and/or radiotherapy (if given)
- Females aged 21 years and older
- ≤ 8 weeks from breast surgery, or the last adjuvant chemotherapy or radiotherapy session, whichever is latest.
Who cannot join
- Cardiovascular, respiratory, musculoskeletal problems that preclude moderate physical activity.
- Major medical problems that are deemed by the investigator to be unsuitable for enrollment.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Catherine CELES contact
Singapore3 sites, 3 recruiting
- Recruiting
National University Hospital
Singapore, 119074
Professor Soo Chin LEE, MD, +65 67737888, ncis@nuhs.edu.sg
- Recruiting
National Cancer Centre
Singapore, 168583
- Recruiting
Singapore General Hospital
Singapore, 169608
Dr Veronique TAN, MD, +65 62223322, veronique.tan.k.m@singhealth.com.sg
About this study
Official title: Breast Cancer Exercise Intervention Study (BREXINT)
This is a 24-week exercise programme consisting of aerobic exercise and muscle strength training, 3 sessions per week. The first 9 sessions are supervised by physiotherapists in person, followed by 63 sessions monitored remotely (video) or supervised by trainers at ActiveSG (Sport Singapore) gyms.
Read the detailed description
This is a multi-centre, randomised controlled study of a 6-month (24-week) exercise programme versus observation in 2156 early stage and locally advanced breast cancer patients who have undergone curative breast surgery, and who have completed (neo)adjuvant chemotherapy (if given) or radiotherapy (if given). Patients are stratified by centre (NCC/SGH, NUH), menopausal status, ER/PR status, body fat/muscle ratio.
Cardiorespiratory fitness, muscle strength, level of routine daily physical activity, body fat/muscle ratio are monitored during the study period.
Blood is collected at baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks, then annually for 4 times.
Questionnaires are periodically conducted to assess quality of life (QoL). A food diary is kept.
- Being tested
- Exercise Programme, Control
- Keywords
- BREXINT, Muscular Strength, Cardiorespiratory Fitness, Quality of Life
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise ProgrammeBehavioural
Aerobic exercise consists of 20-minute brisk walks or jogs (5-6 km/h) on the treadmill each session, reaching a heart rate corresponding to 50%-70% of the patient's VO2max (VO2max is determined before embarking on the exercise programme). Study participants are expected to aim for 50% VO2max at the start of the exercise programme, and gradually increasing to 70% VO2max in subsequent exercise sessions. Strength training comprises a series of circuit resistance exercises targeting the major muscle groups. Patients will perform 2-4 sets of these exercises each session, 8-10 repetitions per set. Both aerobic exercise and strength training are done in the same session. With warm-up and cool-down, each session is estimated to take up 1 hour.
ControlBehavioural
Usual care group.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | The exercise intervention group will undergo an aerobic exercise and strength training programme, comprising 3 sessions per week, spanning 24 weeks (total: 3x24=72 sessions). Receives: Behavioral: Exercise Programme |
| Control | Experimental | The usual care group. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-Free Survival (DFS)
From the date of randomization to when an event, i.e. relapse, has occurred.
Measured: Up to 5 years.
Secondary outcomes (1)
Overall Survival (OS)
From the date of randomization to when an event, i.e. death, has occurred.
Measured: Up to 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start1 Jul 2023
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early-stage Breast CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible patients will be randomised into 2 groups: exercise (intervention group, N = 1078) and usual care (control group, N = 1078). The exercise intervention group will undergo an aerobic exercise and strength training programme.
- Masking
- None (open label)
- Enrolment
- 2,156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Centre, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Singapore Cancer Society, Genome Institute of Singapore, National University of Singapore, Singapore General Hospital
- Responsible party
- Sponsor
- Investigators
- Dr Elaine LIM, MD, PhD, Principal investigator, National Cancer Centre, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05957068
- Sponsor's protocol ID
- BREXINT
- Acronym
- BREXINT
- Status last verified
- Sep 2025
- First submitted
- 13 Jun 2023
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once data is available, only de-identified IPD will be shared to collaborators.
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Cancer Exercise Intervention Study (BREXINT)
- ClinicalTrials.gov ID
- NCT05957068
- Acronym / sponsor ID
- BREXINT / BREXINT
- Keywords
- BREXINT, Muscular Strength, Cardiorespiratory Fitness, Quality of Life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,156 participants (estimated)
- Lead sponsor
- National Cancer Centre, SingaporeUniversity, hospital or other
- Collaborators
- Singapore Cancer Society, Genome Institute of Singapore, National University of Singapore, Singapore General Hospital
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 May 2033 (estimated)
- First posted
- 24 Jul 2023 (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 is a 24-week exercise programme consisting of aerobic exercise and muscle strength training, 3 sessions per week. The first 9 sessions are supervised by physiotherapists in person, followed by 63 sessions monitored remotely (video) or supervised by trainers at ActiveSG (Sport Singapore) gyms.
Detailed description
This is a multi-centre, randomised controlled study of a 6-month (24-week) exercise programme versus observation in 2156 early stage and locally advanced breast cancer patients who have undergone curative breast surgery, and who have completed (neo)adjuvant chemotherapy (if given) or radiotherapy (if given). Patients are stratified by centre (NCC/SGH, NUH), menopausal status, ER/PR status, body fat/muscle ratio.
Cardiorespiratory fitness, muscle strength, level of routine daily physical activity, body fat/muscle ratio are monitored during the study period.
Blood is collected at baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks, then annually for 4 times.
Questionnaires are periodically conducted to assess quality of life (QoL). A food diary is kept.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Eligible patients will be randomised into 2 groups: exercise (intervention group, N = 1078) and usual care (control group, N = 1078). The exercise intervention group will undergo an aerobic exercise and strength training programme.
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: Exercise ProgrammeThe exercise intervention group will undergo an aerobic exercise and strength training programme, comprising 3 sessions per week, spanning 24 weeks (total: 3x24=72 sessions). |
| Control | Experimental | Behavioral: ControlThe usual care group. |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with histologically or cytologically proven stage 1, 2, or 3 breast cancer
- Patients who have undergone curative breast surgery
- Patients who have received (neo)adjuvant chemotherapy (if given) and/or radiotherapy (if given)
- Females aged 21 years and older
- ≤ 8 weeks from breast surgery, or the last adjuvant chemotherapy or radiotherapy session, whichever is latest.
Key exclusion criteria (2 listed)
- Cardiovascular, respiratory, musculoskeletal problems that preclude moderate physical activity.
- Major medical problems that are deemed by the investigator to be unsuitable for enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise ProgrammeAerobic exercise consists of 20-minute brisk walks or jogs (5-6 km/h) on the treadmill each session, reaching a heart rate corresponding to 50%-70% of the patient's VO2max (VO2max is determined before embarking on the exercise programme). Study participants are expected to aim for 50% VO2max at the start of the exercise programme, and gradually increasing to 70% VO2max in subsequent exercise sessions. Strength training comprises a series of circuit resistance exercises targeting the major muscle groups. Patients will perform 2-4 sets of these exercises each session, 8-10 repetitions per set. Both aerobic exercise and strength training are done in the same session. With warm-up and cool-down, each session is estimated to take up 1 hour. | Behavioural | Exercise |
| ControlUsual care group. | Behavioural | Control |
Primary outcome
Disease-Free Survival (DFS)
Time frame: Up to 5 years.
From the date of randomization to when an event, i.e. relapse, has occurred.
1 secondary outcome
Overall Survival (OS)
Time frame: Up to 5 years.
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 5 Sep 2025.
- Individual participant dataSharing planned: Yes. Once data is available, only de-identified IPD will be shared to collaborators.
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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.
Catherine CELES contact
Dr Elaine LIM, MD, PhD principal investigator
National Cancer Centre, Singapore
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Programme in people with Early-stage Breast Cancer and Locally Advanced Breast Cancer, run by National Cancer Centre, Singapore at 3 sites in Singapore.
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 5 inclusion and 2 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 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Singapore. 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 Dr Elaine LIM, MD, PhD (+65 64368000, elaine.lim.hsuen@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-Free Survival (DFS) (time frame: Up to 5 years.). 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 5 Sep 2025.