Feasibility Study of Stereotactic Body Radiotherapy for Early Breast Cancer (ARTEMIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02065960
Recruitment Status : Recruiting
First Posted : February 19, 2014
Last Update Posted : March 31, 2015
Juravinski Cancer Centre Foundation
Canadian Breast Cancer Foundation
Information provided by (Responsible Party):
Julie Arsenault, Juravinski Cancer Center

February 12, 2014
February 19, 2014
March 31, 2015
February 2014
June 2016   (Final data collection date for primary outcome measure)
Feasibility [ Time Frame: At time of radiation treatment delivery ]
The primary outcome for this study will be successful delivery of SBRT as per protocol without a major deviation.
Same as current
Complete list of historical versions of study NCT02065960 on Archive Site
  • Acute Radiation Toxicity [ Time Frame: Within 3 months from radiation ]
  • Late Radiation Toxicity [ Time Frame: 3 months or more after radiation ]
  • Pathological Response [ Time Frame: At time of surgery (10-12 weeks post-radiation) ]
  • Ipsilateral Breast Tumour Recurrence [ Time Frame: At 5 years post-registration ]
  • Disease Free Survival [ Time Frame: At 5 years post-registration ]
Same as current
Not Provided
Not Provided
Feasibility Study of Stereotactic Body Radiotherapy for Early Breast Cancer
Feasibility Study of the Role of Stereotactic Body Radiotherapy for the Treatment of Early Stage Breast Cancer

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.

Not Provided
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Neoplasm
Radiation: Stereotactic body radiotherapy (SBRT)
Other Name: Cyberknife
Experimental: Stereotactic body radiotherapy (SBRT)
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.
Intervention: Radiation: Stereotactic body radiotherapy (SBRT)
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
June 2020
June 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Women age ≥ 70 years;
  • New histological diagnosis of invasive carcinoma of the breast, grade I or II, estrogen and progesterone receptor (ER and PR) positive, HER2 negative on needle biopsy and limited to Stage I (T1 N0 M0) on clinical and radiological assessment with MRI of the breasts and axillary ultrasound;
  • Candidate for breast conserving surgery;
  • Signed study consent form completed prior to study entry.

Exclusion Criteria:

  • Breast cancer with disease within 5 mm from skin or chest wall;
  • Previous or concomitant invasive malignancies treated within 5 years of study entry;
  • Serious non-malignant disease (cardiovascular, pulmonary, systemic lupus or scleroderma), which would preclude to definitive radiation therapy;
  • Psychiatric disorders, which would preclude from obtaining informed consent
  • Geographic inaccessibility for follow-up
Sexes Eligible for Study: Female
70 Years and older   (Senior)
Contact: Shelley Chambers, MA 905-387-9711 ext 64510
Contact: Julie Arsenault, MD, FRCPC 905-387-9495
Not Provided
Not Provided
Julie Arsenault, Juravinski Cancer Center
Juravinski Cancer Center
  • Juravinski Cancer Centre Foundation
  • Canadian Breast Cancer Foundation
Principal Investigator: Julie Arsenault, MD, FRCPC Juravinski Cancer Centre
Principal Investigator: Do-Hoon Kim, BASc, MD, MSc, FRCPC Juravinski Cancer Centre
Principal Investigator: Timothy Whelan, BSc, BM,BCh, MSc, FRCPC Juravinski Cancer Centre
Juravinski Cancer Center
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP