Stereotactic Body Radiation Therapy for Breast Cancer

Not Applicable

Active, not recruiting

• Conditions: Breast Cancer

• Registration Number: NCT03585621
• Lead Sponsor: Toronto Sunnybrook Regional Cancer Centre

Brief Summary

This is a prospective, single institution, phase I-II study of stereotactic body radiotherapy (SBRT) for unresected breast cancer. Twenty-four patients with advanced breast cancer who are not candidates for surgery (metastatic disease, unresectable, medically inoperable) or decline surgery will be enrolled in a prospective study using SBRT (4 fractions of radiation therapy over 12-15 days) as the primary treatment modality.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-06-19
• Study First Submitted QC: 2018-07-11
• Study First Posted: 2018-07-13
• Study Start: 2018-07-17
• Primary Completion: 2024-09-01
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-02
• Last Update Posted: 2025-09-09
• Study Completion: 2026-07-17

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Histologically confirmed diagnosis of invasive breast carcinoma of non-lobular histology.

Unifocal tumour Previously assessed by a breast surgeon and medical oncologist, with no surgery being recommended at time of enrollment.

Primary breast and axillary surgery not recommended/performed due to any of the following:

• distant metastatic disease
• unresectable T4 disease and/or
• medically inoperable and/or
• patient declined breast surgery Stages T1-T4, N1-N2, M0-M1 disease Ability to attend radiation planning and therapy, able to attend for follow-up care Able to provide written informed consent.

Exclusion Criteria

Received chemotherapy within 3 weeks prior to breast SBRT. (Concurrent endocrine therapy is permitted) Multifocal or multicentric tumours. Ipsilateral supraclavicular or infraclavicular nodal disease >= 1cm size that is at the level of or superior to the brachial plexus Unable to meet the brachial plexus dose constraints despite compromising coverage of target volumes - as per the discretion of the treating physician Treatment target volume estimated to occupy > 50% of the ipsilateral whole breast volume.

Locally recurrent breast cancer, with previous radiotherapy to the breast, or previous lumpectomy or mastectomy. Ipsilateral breast implant. Serious non-malignant disease that precludes definitive surgical or radiation treatment (e.g.

scleroderma, systemic lupus erythematosus, cardiovascular/pulmonary/renal disease).

Women who are pregnant or lactating. Psychiatric or addictive disorders that preclude obtaining informed consent or adherence to protocol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Acute toxicity	12 weeks post treatment	Incidence of side effects /toxicity associated with SBRT to the breast, during and in the three months following treatment using CTCAE v4.0

Secondary Outcome Measures

Name	Time	Method
Breast Symptom Scores	2 years post treatment	Patient reported breast symptom scores for bleeding, discharge and odour measured on a scale from 1 (no symptoms) to 10 (worst possible/continuous symptoms) using the Visual Analogue Scale tool
Patient Reported Pain Level	2 years post treatment	Patient reported pain levels measured on a scale from 1 (no pain) to 10 (maximum pain tolerable) using the Visual Analogue Scale for Pain
Patient Reported Quality of Life	2 years post treatment	Patient reported quality of life measured using the VES13 questionnaire.
Tumour Response Rate	2 years post treatment	Measured on follow-up MRI or CT imaging using RECIST criteria

Trial Locations

Locations (1)

Sunnybrook Odette Cancer Centre; 🇨🇦 Toronto, Ontario, Canada