Stereotactic Body Radiation Therapy for Breast Cancer

Last updated: September 2, 2025
Sponsor: Toronto Sunnybrook Regional Cancer Centre
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Breast Cancer

Cancer

Treatment

SBRT

Clinical Study ID

NCT03585621
003-2017
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 attendradiation planning and therapy, able to attend for follow-up care Able to providewritten informed consent.

Exclusion

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

Total Participants: 24
Treatment Group(s): 1
Primary Treatment: SBRT
Phase:
Study Start date:
July 17, 2018
Estimated Completion Date:
July 17, 2026

Connect with a study center

  • Sunnybrook Odette Cancer Centre

    Toronto, Ontario M4N 3M5
    Canada

    Site Not Available

  • Sunnybrook Odette Cancer Centre

    Toronto 6167865, Ontario 6093943 M4N 3M5
    Canada

    Site Not Available

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