Breast CancerSPORT-DSNCT03917498
Single Pre-Operative Radiation Therapy - With Delayed Surgery for Low Risk Breast Cancer
A study testing Single Pre-Operative Radiation Therapy - with Delayed Surgery in people with Breast Cancer, run by Michael Yassa at 1 site in Canada.
Trial summary
To study a single dose of preoperative partial radiotherapy to a low-risk breast tumour. The radiotherapy will be goven 3 months before surgery. Read more about this study
- Who is it for?
- Ages 65 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Single Pre-Operative Radiation Therapy - with Delayed Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2018to 31 Dec 2025
- 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 65 years and older
- Women only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Female aged 65 years or older
- World Health Organization (WHO) performance status 0-2
- Invasive ductal carcinoma proven by biopsy done ≤ 12 weeks from treatment start
- Unifocal disease on preoperative staging ultrasound done ≤ 12 weeks from treatment start
- Tumors less than 2cm clinically on physical exam, as well as on breast ultrasound
- No clinical evidence of nodal disease (i.e. cN0), on physical examination done ≤ 12 weeks from treatment start, as well as on breast ultrasound
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- Estrogen receptor status (ER) positive on biopsy
- Her2 negative on biopsy
- Grade 1 or 2 on biopsy
- Planned surgery is a partial mastectomy with sentinel lymph node biopsy
- Localisation markers placed before treatment
Who cannot join
- Age less than 65 years
- A known deleterious mutation in BRCA 1 and/or BRCA 2
- Clinical tumor size > 2.0 cm in greatest diameter on staging ultrasound
- Tumor histology limited to lobular carcinoma only
- Clinically positive axillary nodes (cN+)
- Lymphovascular invasion on biopsy
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- Pure ductal or lobular carcinoma in situ on biopsy
- Extensive intraductal component on biopsy
- Neoadjuvant hormonal manipulation or chemotherapy
- Prior history of cancer (Patients with prior or concurrent basal cell or squamous cell skin cancers are eligible for the trial)
- More than one primary tumor in different quadrants of the same breast
- Diffuse microcalcifications on mammography
- Paget's disease of the nipple
- Previous irradiation to the ipsilateral breast
- Presence of an ipsilateral breast implant or pacemaker
- Serious non-malignant disease (e.g. cardiovascular, pulmonary, systemic lupus erythematosus (SLE), scleroderma) which would preclude definitive radiation treatment
- Estrogen receptor status (ER) not known
- Currently pregnant or lactating
- Psychiatric or addictive disorders which would preclude obtaining informed consent or adherence to protocol
- Geographic inaccessibility for follow-up
- Lack of preoperative staging with breast and axillary ultrasound
- Inability to adequately plan the patient for the experimental technique
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Pre-Operative Radiation Therapy - With Delayed Surgery (SPORT-DS) for Low Risk Breast Cancer: A Phase 1 Study
To study a single dose of preoperative partial radiotherapy to a low-risk breast tumour. The radiotherapy will be goven 3 months before surgery.
- Conditions
- Breast Cancer
- Being tested
- Single Pre-Operative Radiation Therapy - with Delayed Surgery
- Keywords
- radiation therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Pre-Operative Radiation Therapy - with Delayed SurgeryRadiation
Single Pre-Operative Radiation Therapy - with Delayed Surgery
| Study group | Role | What they receive |
|---|---|---|
| Single Pre-Operative Radiation Therapy with Delayed Surgery | Experimental | Single Pre-Operative Radiation Therapy with Delayed Surgery Receives: Radiation: Single Pre-Operative Radiation Therapy - with Delayed Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of pathological complete response
Measured: at the time of surgery
Secondary outcomes (1)
incidence of radiation toxicity
Measured: in the 2 years after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2019
- Study start1 Apr 2018
- Primary completion28 Feb 2020
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michael Yassa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Michael Yassa, Maisonneuve-Rosemont Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03917498
- Sponsor's protocol ID
- SPORT-DS
- Acronym
- SPORT-DS
- Status last verified
- Nov 2024
- First submitted
- 11 Apr 2019
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lavigne D, Hijal T, Vavassis P, Guilbert MC, Sideris L, Dube P, Gervais MK, Leblanc G, Dufresne MP, Nguyen D, Tiberi D, Mahmoud D, Yassa M. Single preoperative radiation therapy with delayed surgery for low-risk breast cancer: Oncologic outcome, toxicity and cosmesis of the SPORT-DS phase I trial. Radiother Oncol. 2024 Nov;200:110515. doi: 10.1016/j.radonc.2024.110515. Epub 2024 Aug 30.
PubMed 39218041
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Pre-Operative Radiation Therapy - With Delayed Surgery (SPORT-DS) for Low Risk Breast Cancer: A Phase 1 Study
- ClinicalTrials.gov ID
- NCT03917498
- Acronym / sponsor ID
- SPORT-DS / SPORT-DS
- Conditions
- Breast Cancer
- Keywords
- radiation therapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Michael YassaUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 17 Apr 2019 (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.
To study a single dose of preoperative partial radiotherapy to a low-risk breast tumour. The radiotherapy will be goven 3 months before surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Pre-Operative Radiation Therapy with Delayed Surgery | Experimental | Radiation: Single Pre-Operative Radiation Therapy - with Delayed SurgerySingle Pre-Operative Radiation Therapy with Delayed Surgery |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (11 listed)
- Female aged 65 years or older
- World Health Organization (WHO) performance status 0-2
- Invasive ductal carcinoma proven by biopsy done ≤ 12 weeks from treatment start
- Unifocal disease on preoperative staging ultrasound done ≤ 12 weeks from treatment start
- Tumors less than 2cm clinically on physical exam, as well as on breast ultrasound
Key exclusion criteria (22 listed)
- Age less than 65 years
- A known deleterious mutation in BRCA 1 and/or BRCA 2
- Clinical tumor size > 2.0 cm in greatest diameter on staging ultrasound
- Tumor histology limited to lobular carcinoma only
- Clinically positive axillary nodes (cN+)
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 |
|---|---|---|
| Single Pre-Operative Radiation Therapy - with Delayed SurgerySingle Pre-Operative Radiation Therapy - with Delayed Surgery | Radiation | Single Pre-Operative Radiation Therapy with Delayed Surgery |
Primary outcome
rate of pathological complete response
Time frame: at the time of surgery
1 secondary outcome
incidence of radiation toxicity
Time frame: in the 2 years after treatment
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 19 Nov 2024.
- Derived from this study: PubMed 39218041Lavigne D, Hijal T, Vavassis P, Guilbert MC, Sideris L, Dube P, Gervais MK, Leblanc G, Dufresne MP, Nguyen D, Tiberi D, Mahmoud D, Yassa M. Single preoperative radiation therapy with delayed surgery for low-risk breast cancer: Oncologic outcome, toxicity and cosmesis of the SPORT-DS phase I trial. Radiother Oncol. 2024 Nov;200:110515. doi: 10.1016/j.radonc.2024.110515. Epub 2024 Aug 30.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single Pre-Operative Radiation Therapy - with Delayed Surgery in people with Breast Cancer, run by Michael Yassa 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 11 inclusion and 22 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: under way, not looking for participants, as of the sponsor's last update on 19 Nov 2024. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of pathological complete response (time frame: at the time of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03917498, which also lists 1 linked publication.
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 19 Nov 2024; AzTrials last refreshed its copy on 6 Nov 2026.