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
  Purpose

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 Intervention Phase
Breast Neoplasm
Radiation: Stereotactic body radiotherapy (SBRT)
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Feasibility Study of the Role of Stereotactic Body Radiotherapy for the Treatment of Early Stage Breast Cancer

Resource links provided by NLM:


Further study details as provided by Juravinski Cancer Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 32
Study Start Date: February 2014
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02065960

Contacts
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

Locations
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
Investigators
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
  More Information

No publications provided

Responsible Party: Julie Arsenault, MD, FRCPC, Clinical Research Fellow, Radiation Oncology, Juravinski Cancer Center
ClinicalTrials.gov Identifier: NCT02065960     History of Changes
Other Study ID Numbers: 13-699
Study First Received: February 12, 2014
Last Updated: March 7, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Juravinski Cancer Center:
Feasibility study
Early breast cancer
Stereotactic body radiotherapy
Cyberknife
Pre-operative radiotherapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 18, 2014