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Radiation

Stereotactic body radiotherapy (SBRT) for Breast Cancer (ARTEMIS Trial)

Phase 1
Waitlist Available
Led By Do-Hoon Kim, BASc, MD, MSc, FRCPC
Research Sponsored by Juravinski Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 5 years post-registration
Awards & highlights

ARTEMIS Trial Summary

Most women with early breast cancer are treated with breast conserving therapy (BCT), consisting of breast conserving surgery (surgery to remove the cancer itself) followed by radiation to the breast. This treatment can take time and is associated with its own side effect profile. An innovative radiation technique called stereotactic body radiotherapy (SBRT) can deliver large doses of radiation precisely to the tumour while avoiding critical organs, therefore destroying the cancer and avoiding surgery altogether. SBRT has been successfully used for a number of cancers and it is proposed that it could be used to eradicate breast cancer. This feasibility study will investigate the feasibility and safety of treatment using SBRT in women with early stage breast cancer. Thirty-two women age 70 years or older with early breast cancer will be treated with SBRT (5 treatments) followed by breast conserving surgery and hormonal therapy. An MRI and breast conserving surgery will be performed at 8-12 weeks after radiation to assess response to treatment. The primary outcome of the study will be feasibility, meaning the ability to deliver radiation treatment as planned. Secondary outcomes will include treatment related toxicity and pathological response. If this study shows that SBRT can be used to treat patients primarily, it will lead to further evaluation of SBRT for early breast cancer.

Eligible Conditions
  • Breast Cancer

ARTEMIS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 5 years post-registration
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 5 years post-registration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility
Secondary outcome measures
Acute Radiation Toxicity
Disease Free Survival
Ipsilateral Breast Tumour Recurrence
+2 more

ARTEMIS Trial Design

1Treatment groups
Experimental Treatment
Group I: Stereotactic body radiotherapy (SBRT)Experimental Treatment1 Intervention
Radiotherapy with SBRT to a dose of 40 Gy in 5 fractions delivered every other day over a period of 10-12 days, followed by breast conserving surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic body radiotherapy (SBRT)
2015
Completed Phase 1
~50

Find a Location

Who is running the clinical trial?

Juravinski Cancer CenterLead Sponsor
12 Previous Clinical Trials
2,277 Total Patients Enrolled
2 Trials studying Breast Cancer
660 Patients Enrolled for Breast Cancer
Canadian Breast Cancer FoundationOTHER
25 Previous Clinical Trials
8,251 Total Patients Enrolled
15 Trials studying Breast Cancer
6,753 Patients Enrolled for Breast Cancer
Juravinski Cancer Centre FoundationOTHER
11 Previous Clinical Trials
1,885 Total Patients Enrolled
1 Trials studying Breast Cancer
40 Patients Enrolled for Breast Cancer

Frequently Asked Questions

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~3 spots leftby Apr 2025