NCT05217966
Recruiting
Not Applicable
Single Pre-Operative Radiation Therapy - With Delayed or No Surgery (SPORT-DNS) for Low Risk Breast Cancer: A Phase II Study
ConditionsBreast Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Maisonneuve-Rosemont Hospital
- Enrollment
- 80
- Locations
- 2
- Primary Endpoint
- Incidence of pathological complete response
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
Eligible women will receive neoadjuvant single fraction radiotherapy followed by surgery performed after one year
Investigators
Michael Yassa
Radiation Oncologist
Maisonneuve-Rosemont Hospital
Eligibility Criteria
Inclusion Criteria
- •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-
- •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.
Exclusion Criteria
- •Age less than 50 years.
- •Premenopausal or uncertain menopausal status.
- •A known deleterious mutation in BRCA 1 and/or BRCA
- •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.
- •Neoadjuvant hormonal manipulation or chemotherapy.
Outcomes
Primary Outcomes
Incidence of pathological complete response
Time Frame: 12 months
Secondary Outcomes
- Incidence of grade 3 or greater radiation toxicity(0-5 years)
Study Sites (2)
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