Breast CancerSPORT-DNSNCT05217966
Single Pre-Operative Radiation Therapy - With Delayed or No Surgery (SPORT-DNS)
A study testing Radiation: Single Pre-Operative Radiation Therapy in people with Breast Cancer, run by Maisonneuve-Rosemont Hospital at 2 sites in Canada.
Trial summary
Eligible women will receive neoadjuvant single fraction radiotherapy followed by surgery performed after one year Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Radiation: Single Pre-Operative Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesCanada
- Study dates
- 8 Oct 2021to 31 Dec 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 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female aged 50 years or older.
- Postmenopausal status (Defined as: age 60 OR bilateral ovariectomy OR amenorrhea > 12 months prior to breast cancer diagnosis without using oral contraceptives/hormone replacement therapy) (65).
- 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 or MRI done ≤ 12 weeks from treatment start.
- Tumors less than or equal to 2cm clinically on physical exam, as well as on breast ultrasound.
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- No clinical evidence of nodal disease (i.e. cN0), on physical examination done ≤ 12 weeks from treatment start, as well as on breast ultrasound.
- Estrogen receptor status (ER) positive on biopsy ≥ 80%.
- Progesterone receptor status (PR) positive on biopsy ≥ 20%.
- Her2 negative on biopsy.
- No lymphovascular invasion on biopsy.
- Low Oncotype DX recurrence score performed on biopsy specimen (RS ≤18).
- Planned surgery is a partial mastectomy with sentinel lymph node biopsy.
Who cannot join
- Age less than 50 years.
- Premenopausal or uncertain menopausal status.
- 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+).
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- Lymphovascular invasion on biopsy.
- Pure ductal or lobular carcinoma in situ on biopsy.
- Extensive intraductal component on biopsy.
- Neoadjuvant hormonal manipulation or chemotherapy.
- Prior non basal cell or squamous cell skin cancers within 5 years.
- 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.
- Prior breast cancer.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
Maisonneuve-Rosemont Hospital
Montreal, Quebec, H1T 2M4
Michael Yassa, MD, 514-252-3425
Michael Yassa, MD
- Recruiting
McGill University Health Center
Montreal, Quebec, H4A 3J1
Tarek Hijal, MD, (514) 934-1934
Tarek Hijal, MD
About this study
Official title: Single Pre-Operative Radiation Therapy - With Delayed or No Surgery (SPORT-DNS) for Low Risk Breast Cancer: A Phase II Study
Eligible women will receive neoadjuvant single fraction radiotherapy followed by surgery performed after one year
- Conditions
- Breast Cancer
- Being tested
- Radiation: Single Pre-Operative Radiation Therapy
- Keywords
- ablative radiotherapy, preoperative radiotherapy, neoadjuvant radiotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation: Single Pre-Operative Radiation TherapyRadiation
Ablative preoperative partial breast radiation therapy
| Study group | Role | What they receive |
|---|---|---|
| Preoperative radiotherapy for early breast cancer | Experimental | Radiation: Single Pre-Operative Radiation Therapy Receives: Radiation: Radiation: Single Pre-Operative Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of pathological complete response
Measured: 12 months
Secondary outcomes (1)
Incidence of grade 3 or greater radiation toxicity
Measured: 0-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start8 Oct 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 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.
- 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maisonneuve-Rosemont Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Responsible party
- Principal investigator, Michael Yassa, Maisonneuve-Rosemont Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05217966
- Sponsor's protocol ID
- MP-12-2021-2565
- Acronym
- SPORT-DNS
- Status last verified
- Nov 2024
- First submitted
- 18 Jan 2022
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 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 or No Surgery (SPORT-DNS) for Low Risk Breast Cancer: A Phase II Study
- ClinicalTrials.gov ID
- NCT05217966
- Acronym / sponsor ID
- SPORT-DNS / MP-12-2021-2565
- Conditions
- Breast Cancer
- Keywords
- ablative radiotherapy, preoperative radiotherapy, neoadjuvant radiotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Maisonneuve-Rosemont HospitalUniversity, hospital or other
- Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Study start
- 8 Oct 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 1 Feb 2022 (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.
Eligible women will receive neoadjuvant single fraction radiotherapy followed by surgery performed after one year
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preoperative radiotherapy for early breast cancer | Experimental | Radiation: Radiation: Single Pre-Operative Radiation TherapyRadiation: Single Pre-Operative Radiation Therapy |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Female aged 50 years or older.
- Postmenopausal status (Defined as: age 60 OR bilateral ovariectomy OR amenorrhea > 12 months prior to breast cancer diagnosis without using oral contraceptives/hormone replacement therapy) (65).
- 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 or MRI done ≤ 12 weeks from treatment start.
Key exclusion criteria (24 listed)
- Age less than 50 years.
- Premenopausal or uncertain menopausal status.
- 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.
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 |
|---|---|---|
| Radiation: Single Pre-Operative Radiation TherapyAblative preoperative partial breast radiation therapy | Radiation | Preoperative radiotherapy for early breast cancer |
Primary outcome
Incidence of pathological complete response
Time frame: 12 months
1 secondary outcome
Incidence of grade 3 or greater radiation toxicity
Time frame: 0-5 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 19 Nov 2024.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiation: Single Pre-Operative Radiation Therapy in people with Breast Cancer, run by Maisonneuve-Rosemont Hospital at 2 sites 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 13 inclusion and 24 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 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 2 sites 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 Michael Yassa (514-252-3425 ext. 0, michael.yassa.med@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of pathological complete response (time frame: 12 months). 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 19 Nov 2024.