Single Pre-Operative Radiation Therapy - With Delayed or No Surgery (SPORT-DNS)
ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age50+
SponsorMaisonneuve-Rosemont Hospital
About this trial
Eligible women will receive neoadjuvant single fraction radiotherapy followed by surgery performed after one year
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Radiation: Single Pre-Operative Radiation Therapy
RadiationAblative preoperative partial breast radiation therapy
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: Preoperative radiotherapy for early breast cancerExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of pathological complete response
Time frame
12 monthsSecondary outcomes
1
Incidence of grade 3 or greater radiation toxicity
Time frame
0-5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Maisonneuve-Rosemont Hospital
Lead sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborator
Source ClinicalTrials.gov