NCT03917498Active, not recruitingNot Applicable
Single Pre-Operative Radiation Therapy - With Delayed Surgery (SPORT-DS) for Low Risk Breast Cancer: A Phase 1 Study
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Michael Yassa
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- rate of pathological complete response
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
- •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
Exclusion Criteria
- •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
- •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
Outcomes
Primary Outcomes
rate of pathological complete response
Time Frame: at the time of surgery
Secondary Outcomes
- incidence of radiation toxicity(in the 2 years after treatment)
Investigators
Michael Yassa
Radiation Oncologist
Maisonneuve-Rosemont Hospital
Study Sites (2)
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