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

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.

Study Overview

• Status: Unknown
• Conditions: Breast Neoplasm
• Intervention / Treatment: Radiation: Stereotactic body radiotherapy (SBRT)

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Julie Arsenault, MD, FRCPC; Phone Number: 905-387-9495; Email: julie.arsenault@jcc.hhsc.ca

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8V 5C2
      • Recruiting
      • Juravinski Cancer Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Cyberknife

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility	The primary outcome for this study will be successful delivery of SBRT as per protocol without a major deviation.	At time of radiation treatment delivery

Secondary Outcome Measures

Outcome Measure	Time Frame
Acute Radiation Toxicity	Within 3 months from radiation
Late Radiation Toxicity	3 months or more after radiation
Pathological Response	At time of surgery (10-12 weeks post-radiation)
Ipsilateral Breast Tumour Recurrence	At 5 years post-registration
Disease Free Survival	At 5 years post-registration

Collaborators and Investigators

• Sponsor: Juravinski Cancer Center
• Collaborators: Canadian Breast Cancer Foundation; Juravinski Cancer Centre 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

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (ANTICIPATED): June 1, 2016
• Study Completion (ANTICIPATED): June 1, 2020

Study Registration Dates

• First Submitted: February 12, 2014
• First Submitted That Met QC Criteria: February 14, 2014
• First Posted (ESTIMATE): February 19, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): March 31, 2015
• Last Update Submitted That Met QC Criteria: March 30, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Feasibility study; Stereotactic body radiotherapy; Early breast cancer; Cyberknife; Pre-operative radiotherapy
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 13-699