New radiation approach offers hope for inoperable breast cancer
NCT ID NCT03585621
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tests a high-precision radiation technique called SBRT for people with advanced breast cancer who cannot have surgery. Twenty-four participants will receive four radiation doses over two weeks. Researchers will track side effects and quality of life to see if this approach is safe and effective.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- stereotactic body radiation therapy (SBRT)
- What this could lead to
- If successful, SBRT could offer a non-surgical option to control breast tumors in patients with advanced or inoperable cancer.
- What could go wrong
- This is a small, early-phase study (24 people) focused on safety and side effects. It may not lead to a standard treatment, and radiation can cause skin irritation, fatigue, or other side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2018
- Expected to finish
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Jul 2026
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Sunnybrook Odette Cancer Centre
Toronto, Ontario, M4N 3M5, Canada
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Other studies related to the condition(s) this trial covers.
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