Could one radiation dose before breast surgery replace weeks of treatment?
NCT ID NCT02212860
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested giving focused radiation before breast cancer surgery instead of the usual 5-6 weeks after surgery. 139 women with early-stage breast cancer received either one or three doses of radiation before their lumpectomy. The goal was to see if this approach can prevent the cancer from coming back and spare patients from lengthy radiation schedules. Researchers also looked at safety, immune effects, and breast appearance satisfaction.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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139 people
The number who actually took part.
- Started
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Apr 2015
- Finished
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Apr 2024
- Lead sponsor
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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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50 years and older
- Sex
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Female participants only
- Healthy volunteers
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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: * Age ≥ 50 years and postmenopausal * Tumor size \< 3cm on pre-treatment imaging * Any grade of disease, estrogen receptor (ER) positive * Unicentric/unifocal disease * Invasive ductal carcinoma or other favorable subtypes of epithelial breast malignancy (lobular, medullary, papillary, colloid, mucinous, or tubular) . * Clinically node-negative (based upon pre-treatment physical examination and/or axillary ultrasound). * Surgical expectation that a \> 2mm margin can be obtained. * Lesion is 1 cm or greater from the skin surface. * Able to have surgery within 14-20 days of radiation therapy. * Able to lie comfortably in the prone position with arms raised above the head for extended periods of time. Exclusion Criteria: * Previous RT to the same breast * Evidence of suspicious diffuse microcalcifications in the breast prior to the start of radiation. * Local metastatic spread into ipsilateral axilla and/or supraclavicular region and/or neck nodes and/or internal mammary nodes diagnosed on clinical examination or any imaging assessment (unless such sites can be confirmed as negative following biopsy) * Distant metastases * Involvement of contralateral axillary, supraclavicular, infraclavicular or internal mammary nodes (unless there is histologic confirmation that these nodes are negative) * Prior non-hormonal therapy or radiation therapy for the current breast cancer * Patients with Paget's disease of the nipple. * Skin involvement, regardless of tumor size. * Patients with a breast technically unsatisfactory for radiation therapy. * Inability to lie prone with arms raised above head for extended periods of time. * Patients not appropriate for breast conserving surgery due to expectation of poor cosmetic result, even without RT * Collagen vascular disease (particularly lupus, scleroderma, dermatomyositis) * Inability or unwillingness to provide informed consent. * Any other malignancy at any site (except non-melanomatous skin cancer) \< 5 years prior to study enrollment * Patients who are pregnant or lactating
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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
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London Regional Cancer Program of the Lawson Health Research Institute
London, Ontario, N6A 4L6, Canada
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Other studies related to the condition(s) this trial covers.
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