Could a short course of radiation before surgery spare more breast tissue?
NCT ID NCT02186470
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This pilot study tested whether giving a high dose of focused radiation (APBI) to the tumor before surgery is feasible for older women with early-stage, hormone-sensitive breast cancer. Twenty-two participants received radiation followed by a lumpectomy. The goal was to see if this approach could shrink the tumor and reduce the amount of healthy tissue removed, while keeping side effects manageable.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- accelerated partial breast irradiation (APBI)
- What this could lead to
- If successful, this approach could allow some patients to have less extensive surgery and better cosmetic outcomes after breast cancer treatment.
- What could go wrong
- This is a very small, early feasibility study with only 22 participants, so results may not apply to all patients. Radiation before surgery can cause side effects like skin reactions or changes in healing.
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
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22 people
The number who actually took part.
- Started
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Apr 2016
- Finished
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Sep 2025
- 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
-
50 years and older
- Sex
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Female participants only
- 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: * The patient must consent to be in the study and must have signed an approved consent form conforming with federal and institutional guidelines. * Patient must be ≥ 50 years * Core biopsy demonstrating breast cancer and receptors that are ER or PR positive. * Core tissue must have HER 2 negative followed by current ASCO/CAP guidelines. * The patient must have clinical node negative, stage I breast cancer. * The surgical treatment must be intended to be a lumpectomy * The biopsy site must have been demarcated by a clip(s) * Gross disease must be unifocal on Mammo/ MRI imaging * Patients must have estrogen receptor (ER) and progesterone receptor (PR) analysis performed on core biopsy * Patient must be able to tolerate lying in the prone position with arms extended forward. * Must be able to tolerate MRI scan with contrast * At the time of enrollment, patients must have had bilateral mammograms within 6 months. * Patients must be willing to undergo breast cancer surgery minimally 4, maximally 6 weeks post APBI. * Patients with a history of non-breast malignancies are eligible if they have been disease free for 5 or more years prior to enrollment and are deemed by their physicians to be at low risk for recurrence. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin. Exclusion Criteria: * Age \< 50 years * Hormone unresponsive breast cancer * T-2 ( \> 3.0 cm), T-3, Stage III, or Stage IV breast cancer. * N-1, N-2, or N-3 clinical axillary nodes * Mastectomy intended * Unwilling to undergo anti-endocrine therapy * Suspicious microcalcification, densities, or palpable abnormalities ( in the ipsilateral or contralateral breast) unless biopsied and found to be benign. * Non-epithelial breast malignancies such as sarcoma or lymphoma. * Paget's disease of the nipple * Proven multicentric carcinoma (invasive or DCIS) in more than one quadrant or separated by \> 4 centimeters. * Any prior treatment with radiation therapy, chemotherapy, biotherapy, or hormone therapy for the currently diagnosed breast cancer prior to study enrollment. * Prior breast or thoracic RT for any condition. * Psychiatric of addictive disorders or other condition that in the opinion of the investigator would preclude the patient from meeting the study requirements.
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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
-
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
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