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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. Read our disclaimer for details. Identifier: NCT02065960
Recruitment Status : Unknown
Verified March 2015 by Julie Arsenault, Juravinski Cancer Center.
Recruitment status was:  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

Brief 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.

Condition or disease Intervention/treatment Phase
Breast Neoplasm Radiation: Stereotactic body radiotherapy (SBRT) Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility Study of the Role of Stereotactic Body Radiotherapy for the Treatment of Early Stage Breast Cancer
Study Start Date : February 2014
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
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.
Radiation: Stereotactic body radiotherapy (SBRT)
Other Name: Cyberknife

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Acute Radiation Toxicity [ Time Frame: Within 3 months from radiation ]
  2. Late Radiation Toxicity [ Time Frame: 3 months or more after radiation ]
  3. Pathological Response [ Time Frame: At time of surgery (10-12 weeks post-radiation) ]
  4. Ipsilateral Breast Tumour Recurrence [ Time Frame: At 5 years post-registration ]
  5. Disease Free Survival [ Time Frame: At 5 years post-registration ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02065960

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Contact: Shelley Chambers, MA 905-387-9711 ext 64510
Contact: Julie Arsenault, MD, FRCPC 905-387-9495

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Canada, Ontario
Juravinski Cancer Centre Recruiting
Hamilton, Ontario, Canada, L8V 5C2
Sponsors and Collaborators
Juravinski Cancer Center
Juravinski Cancer Centre Foundation
Canadian Breast Cancer Foundation
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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
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Responsible Party: Julie Arsenault, MD, FRCPC, Clinical Research Fellow, Radiation Oncology, Juravinski Cancer Center Identifier: NCT02065960    
Other Study ID Numbers: 13-699
First Posted: February 19, 2014    Key Record Dates
Last Update Posted: March 31, 2015
Last Verified: March 2015
Keywords provided by Julie Arsenault, Juravinski Cancer Center:
Feasibility study
Early breast cancer
Stereotactic body radiotherapy
Pre-operative radiotherapy
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases