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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Juravinski Cancer Center
Sponsor:
Collaborators:
Juravinski Cancer Centre Foundation
Canadian Breast Cancer Foundation
Information provided by (Responsible Party):
Julie Arsenault, Juravinski Cancer Center
ClinicalTrials.gov Identifier:
NCT02065960
First received: February 12, 2014
Last updated: March 7, 2014
Last verified: March 2014

February 12, 2014
March 7, 2014
February 2014
June 2015   (final data collection date for primary outcome measure)
Feasibility [ Time Frame: At time of radiation treatment delivery ] [ Designated as safety issue: Yes ]
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 ClinicalTrials.gov Archive Site
  • Acute Radiation Toxicity [ Time Frame: Within 3 months from radiation ] [ Designated as safety issue: Yes ]
  • Late Radiation Toxicity [ Time Frame: 3 months or more after radiation ] [ Designated as safety issue: Yes ]
  • Pathological Response [ Time Frame: At time of surgery (10-12 weeks post-radiation) ] [ Designated as safety issue: No ]
  • Ipsilateral Breast Tumour Recurrence [ Time Frame: At 5 years post-registration ] [ Designated as safety issue: No ]
  • Disease Free Survival [ Time Frame: At 5 years post-registration ] [ Designated as safety issue: No ]
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
Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
32
June 2020
June 2015   (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
Female
70 Years and older
No
Contact: Shelley Chambers, MA 905-387-9711 ext 64510 shelley.chambers@jcc.hhsc.ca
Contact: Julie Arsenault, MD, FRCPC 905-387-9495 julie.arsenault@jcc.hhsc.ca
Canada
 
NCT02065960
13-699
Yes
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 2014

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