Single Pre-Operative Radiation Therapy - With Delayed Surgery (SPORT-DS) for Low Risk Breast Cancer: A Phase 1 Study

Michael Yassa1 site in 1 country20 target enrollmentApril 1, 2018

Overview

To study a single dose of preoperative partial radiotherapy to a low-risk breast tumour. The radiotherapy will be goven 3 months before surgery.

Registry

clinicaltrials.gov

Start Date

April 1, 2018

End Date

December 31, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

Female

Sponsor

Responsible Party

Sponsor Investigator

Principal Investigator

Michael Yassa

Radiation Oncologist

Maisonneuve-Rosemont Hospital

•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

•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)