Radioactive seeds zap breast cancer in one shot
NCT ID NCT02297672
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a one-time radiation treatment for early-stage breast cancer. After a lumpectomy, tiny radioactive seeds are placed directly into the breast to kill any remaining cancer cells. The goal is to see if this method is safe, works well, and costs less than standard daily radiation. The study includes 75 women over 55 with small, low-grade tumors.
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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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75 people
The number who actually took part.
- Started
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Feb 2015
- Expected to finish
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Feb 2026
An estimate. End dates often move.
- 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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55 to 80 years
- 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: * Patient consent and signature of approved consent form. * Age greater than 55 years and postmenopausal. * Life expectancy of at least ten years * Stage 0 or I breast cancer. Tumour size \< 2 cm. * Invasive cancer must be pathologic grade 1 or 2 * Histology must be either Ductal Carcinoma In Situ or invasive ductal adenocarcinoma of the breast. * Tumour removed by lumpectomy with clear margins (DCIS and invasive). * Unifocal disease * For invasive breast cancer, axillary staging by either sentinel node biopsy or axillary dissection (minimum of 6 axillary nodes). Not required for DCIS. * Brachytherapy generally should be performed within 16 weeks of the last surgery (lumpectomy, re-excision of margins, or axillary staging procedure). If \> 16 weeks, will be assessed on case-by-case basis, based on seroma visibility and the presence of surgical clips in the tumour bed. * Tumour must be Estrogen Receptor positive. * The lumpectomy cavity (seroma) must be clearly delineated by ultrasound and CT and should be \< 3 cm diameter (equivalent sphere) resulting in a maximum of 125 cc planning target volume (PTV). * Breast seed implant must be considered technically deliverable by interstitial brachytherapy by the attending radiation oncologist and must be a minimum 2-plane implant. * If prior non-breast malignancies, must have been disease-free for 5 or more years. Time limit waived for carcinoma in-situ of the cervix or colon, melanoma in-situ, and basal or squamous cell carcinoma of the skin. Exclusion Criteria: * Stage T2 or higher breast cancer * Histologically positive axillary nodes. * High grade (grade 3) invasive ductal carcinoma * Extensive DCIS * Lymphatic or Vascular Invasion positive * Significant persistent post surgical complications * Palpable or radiographically suspicious ipsilateral or contralateral axillary, or regional nodes, unless histologically confirmed negative. * Suspicious microcalcifications, densities, or palpable abnormalities in the ipsilateral or contralateral breast unless confirmed benign. * Proven multi-centric carcinoma (invasive cancer or DCIS) * Paget's disease of the nipple. * Synchronous bilateral invasive or non-invasive breast cancer. * History of previous ipsilateral invasive breast cancer or DCIS. * Surgical margins that are positive or cannot be microscopically assessed. * Clear delineation of the target lumpectomy cavity not possible. * Breast implants. * Prior ipsilateral breast or thoracic radiotherapy. * Known genetic mutation in Breast Cancer Associated (BRCA 1 or 2) * Collagen vascular disease,
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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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BCCA Center for the Southern Interior
Kelowna, British Columbia, V1Y 5L3, Canada
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Other studies related to the condition(s) this trial covers.
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