Status:
RECRUITING
Single Pre-Operative Radiation Therapy - With Delayed or No Surgery (SPORT-DNS)
Lead Sponsor:
Maisonneuve-Rosemont Hospital
Collaborating Sponsors:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Conditions:
Breast Cancer
Eligibility:
FEMALE
50+ years
Phase:
NA
Brief Summary
Eligible women will receive neoadjuvant single fraction radiotherapy followed by surgery performed after one year
Eligibility Criteria
Inclusion
- 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.
- 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.
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.
- 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.
Key Trial Info
Start Date :
October 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2030
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05217966
Start Date
October 8 2021
End Date
December 31 2030
Last Update
November 19 2024
Active Locations (2)
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1
Maisonneuve-Rosemont Hospital
Montreal, Quebec, Canada, H1T 2M4
2
McGill University Health Center
Montreal, Quebec, Canada, H4A 3J1