Stereotactic Body Radiation Therapy for Breast Cancer

A Phase I-II Study of Stereotactic Body Radiation Therapy for Breast Cancer (SBRT Breast)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Radiation: SBRT

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Odette Cancer Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SBRT to the Primary Breast Tumour; SBRT to the breast using 4 sequentially escalating dose levels from 9Gy to 12 Gy.	Radiation: SBRT; Each radiation treatment plan will be customized to the patient and tumour in order to deliver highly conformal, conebeam CT guided SBRT radiotherapy in 4 fractions delivered over 2-4 weeks.; Other Names: SABR

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breast Symptom Scores	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	2 years post treatment
Patient Reported Quality of Life	Patient reported quality of life measured using the combined EORTC QLQ-C30 and QLQ-BR23 questionnaires	2 years post treatment
Patient Reported Quality of Life	Patient reported quality of life measured using the VES13 questionnaire.	2 years post treatment
Patient Reported Pain Level	Patient reported pain levels measured on a scale from 1 (no pain) to 10 (maximum pain tolerable) using the Visual Analogue Scale for Pain	2 years post treatment
Tumour Response Rate	Measured on follow-up MRI or CT imaging using RECIST criteria	2 years post treatment

Collaborators and Investigators

• Sponsor: Toronto Sunnybrook Regional Cancer Centre
• Investigators: Principal Investigator: Danny Vesprini, MD, FRCPC, Sunnybrook Health Sciences Centre, University of Toronto

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2018
• Primary Completion (Actual): September 1, 2024
• Study Completion (Estimated): July 17, 2026

Study Registration Dates

• First Submitted: June 19, 2018
• First Submitted That Met QC Criteria: July 11, 2018
• First Posted (Actual): July 13, 2018

Study Record Updates

• Last Update Posted (Estimated): September 9, 2025
• Last Update Submitted That Met QC Criteria: September 2, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: 003-2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No