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NCT Number: NCT03585621

Stereotactic Body Radiation Therapy for Breast Cancer

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sunnybrook Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: SABR

Primary outcomes

  1. Acute toxicity

    Time frame: 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 outcomes

  1. Breast Symptom Scores

    Time frame: 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

  2. Patient Reported Quality of Life

    Time frame: 2 years post treatment

    Patient reported quality of life measured using the combined EORTC QLQ-C30 and QLQ-BR23 questionnaires

  3. Patient Reported Quality of Life

    Time frame: 2 years post treatment

    Patient reported quality of life measured using the VES13 questionnaire.

  4. Patient Reported Pain Level

    Time frame: 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

  5. Tumour Response Rate

    Time frame: 2 years post treatment

    Measured on follow-up MRI or CT imaging using RECIST criteria

Sponsors and collaborators

Lead sponsor

Toronto Sunnybrook Regional Cancer Centre

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2024
Study completion
2026
First posted
Jul 13, 2018
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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