Could a single day of radiation replace weeks of treatment for breast cancer?
NCT ID NCT07654257
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
The SASHA trial is testing whether a single, high-dose radiation treatment delivered directly to the tumor site over one day is safe and effective for women with early-stage breast cancer. The study will enroll 134 women aged 40-85 who have already had a lumpectomy. Researchers will monitor side effects and cosmetic results for up to five years.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- radiation therapy (brachytherapy)
- What this could lead to
- If successful, this could offer a faster, more convenient radiation option for early-stage breast cancer with fewer side effects.
- What could go wrong
- This is a phase 2 trial with only 134 participants, so results are preliminary. The single high dose may cause unexpected side effects or not be as effective as standard longer courses.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 134 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2036
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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40 to 85 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: * Female * New diagnosis of Ductal Carcinoma in Situ (DCIS) and/or invasive breast carcinoma per histologic evaluation * Age 40-85 at diagnosis * Previous lumpectomy with surgical margins histologically free of invasive tumor and DCIS as determined by the pathologist * T stage of Tis, T1, or T2 * T2 tumors must be ≤3 cm in maximum diameter * If the tumor is human epidermal growth factor receptor (HER2)-positive, the patient is planning to receive or has already received HER2-directed therapy * For patients with invasive breast cancer, an axillary staging procedure must be performed (either sentinel node biopsy alone or axillary dissection \[with a minimum of 6 axillary nodes removed\]) and the axillary node(s) must be pathologically negative Note: N0(i+) is not an exclusion criterion Note: Patients meeting all of the following criteria are not required to undergo the axillary staging procedure: * ≥70 years of age * Estrogen receptor (ER)+, progesterone receptor (PR)+/-, HER2- * Grade 1-2 breast cancer * Tumor ≤2 cm in size Note: If patients meet all the following criteria, the decision to avoid sentinel lymph node biopsy can be at the discretion of the breast surgeon: * 50-69 years of age * Grade 1-2 breast cancer * Clinically negative axilla by ultrasound and/or magnetic resonance imaging (MRI) * ER+, PR+, HER2- * Tumor ≤2 cm in size * Agrees to comply with aromatase inhibitor recommendation * Ability to begin brachytherapy within 12 weeks following lumpectomy, re- excision of margins, or completion of chemotherapy * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Pregnant or breastfeeding * Active collagen-vascular disease * Paget's disease of the breast * Any prior history of DCIS or invasive breast cancer prior to the current diagnosis * Any prior history of breast radiation therapy (RT) or thoracic RT for any condition * Multicentric carcinoma (DCIS or invasive) * Synchronous bilateral invasive or non-invasive breast cancer * Surgical margins that cannot be microscopically assessed or that are positive * Treatment with neoadjuvant chemotherapy * Excision cavity that cannot be clearly delineated or is not amenable to implant per the treating investigator * Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with 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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Virginia Commonwealth University
Richmond, Virginia, 23298, United States
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Other studies related to the condition(s) this trial covers.
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