Breast CancerSABR PRIMERNCT06937281
SABR PRIMER - Evaluating Stereotactic Ablative Radiotherapy for Primary and Regional Breast Tumors
A study testing SABR in people with Breast Cancer and Metastases, run by British Columbia Cancer Agency at 1 site in Canada.
Trial summary
The study is being done to determine if stereotactic ablative radiotherapy (SABR) can control tumour growth for patients with metastatic breast cancer. Secondary objectives will be overall survival, progression-free survival and time to switch of next line of systemic therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Metastases
- What is being tested?
- SABR
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jul 2025to 30 Jul 2030
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically confirmed AJCC 7th/8th edition Stage IV invasive ductal carcinoma or invasive lobular carcinoma of the breast.
- Measurable disease in the breast, suitable to receive radiotherapy.
- Receiving or planned to receive systemic therapy.
- The following should be held for the duration of treatment: cytotoxic chemotherapy, CDK4/6 inhibitors, T-DXd
- Patients are allowed to have SABR for oligometastatic disease as clinically indicated
- Age 18 or older
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- ECOG Performance Status 0-2
- Life expectancy greater than 6 months
- Able and willing to provide informed consent
- Able to complete patient reported outcome questionnaires
Who cannot join
- Contraindications to radiotherapy, including a history of SLE, systemic scleroderma, IPF, ataxia telangiectasia, pregnancy
- Previous history of locoregional radiotherapy to the ipsilateral breast
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
BC Cancer - Vancouver
Vancouver, British Columbia, V5Z 4E6
Sandy Chang, 6048776000, sandy.chang@bccancer.bc.ca
Andrew Bang, MPH MD FRCSC
About this study
Official title: A Phase II Trial Evaluating Stereotactic Ablative Radiotherapy for Primary and Regional Breast Tumors (SABR-PRIMeR)
The study is being done to determine if stereotactic ablative radiotherapy (SABR) can control tumour growth for patients with metastatic breast cancer.
Secondary objectives will be overall survival, progression-free survival and time to switch of next line of systemic therapy.
Radiation-related adverse events will be assess, with a specific focus on dermatitis, lymphedema and brachial plexopathy.
The exploratory objective is to correlate toxicities and outcomes with peripheral blood biomarkers and circulating tumor DNA to potentially help predict responses in future patients receiving combined therapy.
Read the detailed description
Purpose:
The purpose of this study is to determine if stereotactic ablative radiotherapy (SABR) can provide effective locoregional control for patients with metastatic breast cancer. As secondary objectives, the investigators will assess the overall survival, progression-free survival and time to switch of next line of systemic therapy. The investigators will also assess radiation-related adverse events using CTCAE v5.0, with a specific focus on dermatitis, lymphedema and brachial plexopathy. Finally, as an exploratory objective, the investigators aim to correlate toxicities and outcomes with peripheral blood biomarkers and circulating tumor DNA to potentially help predict responses in future patients receiving combined therapy.
Primary Objective:
- Assess median, 1-year and 2-year locoregional control
Secondary Objectives:
- Assess median, 1-year and 2-year overall survival
- Assess median, 1-year and 2-year progression-free survival
- Assess median time to systemic therapy switch
- Assess radiation-related adverse events using CTCAE v5.0
Correlative Objectives:
- Correlate outcomes with peripheral blood-derived parameters
Research Design The trial is designed as a single-arm interventional study investigating stage IV breast cancer with persistent or progressive locoregional disease despite the use of standard systemic therapy A retrospective study will be conducted to create a matched cohort to compare locoregional control rates with patients who received conventional fractionated radiotherapy.
- Conditions
- Breast Cancer, Metastases
- Being tested
- SABR
- Keywords
- SABR
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SABRRadiation
Prescription dose/fractionation: 26Gy/5 with 40Gy/5 +/- 35Gy/5 Boost Radiation Technique: VMAT Treatment Frequency: Every other day (EOD)
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | SABR treatment to Whole breast +/- regional lymph nodes Receives: Radiation: SABR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Locoregional Control
Assess median, 1-year and 2-year locoregional control
Measured: 2 Years
Secondary outcomes (4)
Overall survival
Assess median, 1-year and 2-year overall survival
Measured: 2 Years
Progression Free Survival
Assess median, 1-year and 2-year progression-free survival
Measured: 2 Years
systemic therapy switch
Assess median time to systemic therapy switch
Measured: 2 Years
Adverse Events
Assess radiation-related adverse events using CTCAE v5.0
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start1 Jul 2025 (estimated)
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by British Columbia Cancer AgencyThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- A retrospective study will be conducted to create a matched cohort to compare locoregional control rates with patients who received conventional fractionated radiotherapy.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- British Columbia Cancer Agency
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06937281
- Sponsor's protocol ID
- H25-00274
- Acronym
- SABR PRIMER
- Status last verified
- Apr 2025
- First submitted
- 15 Apr 2025
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial Evaluating Stereotactic Ablative Radiotherapy for Primary and Regional Breast Tumors (SABR-PRIMeR)
- ClinicalTrials.gov ID
- NCT06937281
- Acronym / sponsor ID
- SABR PRIMER / H25-00274
- Conditions
- Breast Cancer, Metastases
- Keywords
- SABR
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- British Columbia Cancer AgencyUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Jul 2030 (estimated)
- First posted
- 22 Apr 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.
The study is being done to determine if stereotactic ablative radiotherapy (SABR) can control tumour growth for patients with metastatic breast cancer.
Secondary objectives will be overall survival, progression-free survival and time to switch of next line of systemic therapy.
Radiation-related adverse events will be assess, with a specific focus on dermatitis, lymphedema and brachial plexopathy.
The exploratory objective is to correlate toxicities and outcomes with peripheral blood biomarkers and circulating tumor DNA to potentially help predict responses in future patients receiving combined therapy.
Detailed description
Purpose:
The purpose of this study is to determine if stereotactic ablative radiotherapy (SABR) can provide effective locoregional control for patients with metastatic breast cancer. As secondary objectives, the investigators will assess the overall survival, progression-free survival and time to switch of next line of systemic therapy. The investigators will also assess radiation-related adverse events using CTCAE v5.0, with a specific focus on dermatitis, lymphedema and brachial plexopathy. Finally, as an exploratory objective, the investigators aim to correlate toxicities and outcomes with peripheral blood biomarkers and circulating tumor DNA to potentially help predict responses in future patients receiving combined therapy.
Primary Objective:
- Assess median, 1-year and 2-year locoregional control
Secondary Objectives:
- Assess median, 1-year and 2-year overall survival
- Assess median, 1-year and 2-year progression-free survival
- Assess median time to systemic therapy switch
- Assess radiation-related adverse events using CTCAE v5.0
Correlative Objectives:
- Correlate outcomes with peripheral blood-derived parameters
Research Design The trial is designed as a single-arm interventional study investigating stage IV breast cancer with persistent or progressive locoregional disease despite the use of standard systemic therapy A retrospective study will be conducted to create a matched cohort to compare locoregional control rates with patients who received conventional fractionated radiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A retrospective study will be conducted to create a matched cohort to compare locoregional control rates with patients who received conventional fractionated radiotherapy.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Radiation: SABRSABR treatment to Whole breast +/- regional lymph nodes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Pathologically confirmed AJCC 7th/8th edition Stage IV invasive ductal carcinoma or invasive lobular carcinoma of the breast.
- Measurable disease in the breast, suitable to receive radiotherapy.
- Receiving or planned to receive systemic therapy.
- Patients are allowed to have SABR for oligometastatic disease as clinically indicated
- Age 18 or older
Key exclusion criteria (2 listed)
- Contraindications to radiotherapy, including a history of SLE, systemic scleroderma, IPF, ataxia telangiectasia, pregnancy
- Previous history of locoregional radiotherapy to the ipsilateral breast
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 |
|---|---|---|
| SABRPrescription dose/fractionation: 26Gy/5 with 40Gy/5 +/- 35Gy/5 Boost Radiation Technique: VMAT Treatment Frequency: Every other day (EOD) | Radiation | Treatment |
Primary outcome
Locoregional Control
Time frame: 2 Years
Assess median, 1-year and 2-year locoregional control
4 secondary outcomes
Overall survival
Time frame: 2 Years
Progression Free Survival
Time frame: 2 Years
systemic therapy switch
Time frame: 2 Years
Adverse Events
Time frame: 2 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 24 Apr 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SABR in people with Breast Cancer and Metastases, run by British Columbia Cancer Agency at 1 site in Canada.
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 10 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: opening soon, as of the sponsor's last update on 24 Apr 2025. 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 Canada. 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 Sandy Chang (6048776000, sandy.chang@bccancer.bc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Locoregional Control (time frame: 2 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 24 Apr 2025.