Stereotactic Body Radiation Therapy for Breast Cancer

NCT ID: NCT03585621

Last Updated: 2025-09-09

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-17
• Study Completion Date: 2026-07-17

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SBRT to the Primary Breast Tumour

SBRT to the breast using 4 sequentially escalating dose levels from 9Gy to 12 Gy.

Group Type: EXPERIMENTAL

SBRT

Intervention Type: RADIATION

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.

Interventions

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.

Intervention Type: RADIATION

Other Intervention Names

SABR

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Toronto Sunnybrook Regional Cancer Centre

OTHER

Sponsor Role: lead

Responsible Party

Danny Vesprini, MD, MSc, FRCPC

Deputy Chief, Department of Radiation Oncology - Clinical Care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Danny Vesprini, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre, University of Toronto

Locations

Sunnybrook Odette Cancer Centre

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

003-2017

Identifier Type: -

Identifier Source: org_study_id