Testing Single Pre-Operative Radiation Therapy for breast cancer
Official title: Single Pre-Operative Radiation Therapy - With Delayed or No Surgery (SPORT-DNS)
Single Pre-Operative Radiation Therapy - With Delayed or No Surgery (SPORT-DNS) for Low Risk Breast Cancer: A Phase II Study
Interventions
Radiation: Single Pre-Operative Radiation Therapy
Ablative preoperative partial breast radiation therapy
Canadian Sites (2)
Maisonneuve-Rosemont Hospital
Montreal, Quebec, Canada
McGill University Health Center
Montreal, Quebec, Canada
Eligibility Criteria
See who this study is looking for37 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +World Health Organization (WHO) performance status 0-2.
- +Female aged 50 years or older.
- +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.
- +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).
- +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).
- +Planned surgery is a partial mastectomy with sentinel lymph node biopsy.
Exclusion
- −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+).
- −Lymphovascular invasion on biopsy.
- −Pure ductal or lobular carcinoma in situ on biopsy.
- −Extensive intraductal component on biopsy.
- −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.
- −Presence of an ipsilateral breast implant or pacemaker.
- −Estrogen receptor status (ER) not known.
- −Psychiatric or addictive disorders which would preclude obtaining informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → or adherence to protocolProtocolThe detailed plan a study must follow.Read more →.
- −Geographic inaccessibility for follow-upFollow-upContinued check-ins after the treatment part is finished.Read more →.
- −Lack of preoperative staging with breast and axillary ultrasound.
- −Inability to adequately plan the patient for the experimental technique.
- −Prior breast cancer.
- −Currently pregnant or lactating.
- −Neoadjuvant hormonal manipulation or chemotherapy.
- −Previous irradiation to the ipsilateral breast.
- −Serious non-malignant disease (e.g. cardiovascular, pulmonary, systemic lupus erythematosus (SLE), scleroderma) which would preclude definitive radiation treatment.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
What is being given or done in this study: Radiation: Single Pre-Operative Radiation Therapy.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
There is only one group in this study, so there is no assignment to different treatments.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
There is one group in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists a minimum age of 50 years, with no upper limit given.
The study lists female participants only.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 80 people.
The study is currently expected to finish around December 2030.
The main measurement is taken over: 12 months.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Incidence of pathological complete response — measured over 12 months.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05217966 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Radiation: Single Pre-Operative Radiation TherapyRadiation
Ablative preoperative partial breast radiation therapy
From the trial registry — its own words, unedited.
What a radiation is here: A form of radiotherapy or radiation-based treatment being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 50 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
There is only one group in this study, so there is no assignment to different treatments.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 50 years, with no upper limit given.
It lists female participants only.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 12 months.
The study as a whole is currently expected to finish around 2030-12-31.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 80 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Montreal, Quebec, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
Eligible women will receive neoadjuvant single fraction radiotherapy followed by surgery performed after one year
Worth passing on?
Save it to the Care Package and send it to them, or to their doctor, in one message. Whether they follow it up is theirs to decide.
Review the Care PackageThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.