Feasibility Study of Stereotactic Body Radiotherapy for Early Breast Cancer

Breast Neoplasm Clinical Trial

— ARTEMIS  

Official title:

Feasibility Study of the Role of Stereotactic Body Radiotherapy for the Treatment of Early Stage Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02065960
• Other study ID #: 13-699
• Status: Recruiting
• Phase: Phase 1
• First received: February 12, 2014
• Last updated: March 30, 2015
• Start date: February 2014
• Est. completion date: June 2020

Study information

• Verified date: March 2015
• Source: Juravinski Cancer Center
• Contact: Shelley Chambers, MA
• Phone: 905-387-9711
• Email: shelley.chambers[@]jcc.hhsc.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: June 2020
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 70 Years and older

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasm
• Breast Neoplasms

Intervention

Radiation:
• Stereotactic body radiotherapy (SBRT)

Locations

Country	Name	City	State
Canada	Juravinski Cancer Centre	Hamilton	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Juravinski Cancer Center	Canadian Breast Cancer Foundation, Juravinski Cancer Centre Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Acute Radiation Toxicity		Within 3 months from radiation	Yes
Secondary	Late Radiation Toxicity		3 months or more after radiation	Yes
Secondary	Pathological Response		At time of surgery (10-12 weeks post-radiation)	No
Secondary	Ipsilateral Breast Tumour Recurrence		At 5 years post-registration	No
Secondary	Disease Free Survival		At 5 years post-registration	No