Stereotactic Body Radiation Therapy for Breast Cancer

NCT03585621 | Active Not Recruiting DMC

• 1 other identifier: 003-2017
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Breast Symptom Scores

  2 years post treatment

• Patient Reported Quality of Life

  2 years post treatment

• Patient Reported Quality of Life

  2 years post treatment

• Patient Reported Pain Level

  2 years post treatment

• Tumour Response Rate

  2 years post treatment

Study Arms (1)

SBRT to the Primary Breast Tumour

EXPERIMENTAL

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

Radiation: SBRT

Interventions

SBRT 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.

Also known as: SABR

SBRT to the Primary Breast Tumour

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Toronto Sunnybrook Regional Cancer Centre: lead

Study Sites (1)

Sunnybrook Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Danny Vesprini, MD, FRCPC

  Sunnybrook Health Sciences Centre, University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Chief, Department of Radiation Oncology - Clinical Care

Model Details: Sequential dose escalation design

Study Record Dates

• First Submitted: June 19, 2018
• First Posted: July 13, 2018
• Study Start: July 17, 2018
• Primary Completion: September 1, 2024
• Study Completion (Estimated): July 17, 2026
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)