Radiation may offer better quality of life than hormone pills for older breast cancer patients
NCT ID NCT05472792
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is for women aged 65 and older with low-risk breast cancer who have had a lumpectomy. It compares two follow-up treatments: a short course of targeted radiation (5 sessions) versus 5 years of hormone pills. The main goal is to see which approach gives a better quality of life after one year. The researchers hope radiation might be easier to tolerate while still keeping the cancer from coming back.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- radiation (accelerated partial breast irradiation) or hormone therapy (tamoxifen, anastrozole, exemestane, letrozole, fulvestrant, toremifene)
- What this could lead to
- If successful, this could show that a short course of radiation after lumpectomy offers better quality of life than years of hormone pills, while still controlling the cancer.
- What could go wrong
- This is a small, early-phase study (90 people) and only looks at 1-2 year outcomes. It may not prove long-term safety or apply to all older women with breast cancer.
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 90 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2022
- Expected to finish
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Apr 2032
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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65 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: 1. Willing and able to provide written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information. 2. Women greater than or equal to age 65 years with de novo invasive carcinoma of breast. 3. Pathological T1 (pT1) stage 4. Estrogen receptor (ER)/ Progesterone receptor (PR) positive (greater than or equal to 10% ER and PR by immunohistochemistry \[IHC\] staining) 5. Human epidermal growth factor receptor 2 (HER2) - according to American Society of Clinical Oncology (ASCO)/ College of American Pathologists (CAP) guidelines (0 or 1+ following IHC staining or proven negative by in-situ hybridization \[ISH\]) 6. Grade 1 or 2 overall tumor grade 7. Clinical or pathological N0 8. No lymphovascular space invasion (LVSI) 9. Final surgical margins ≥ 2 mm as per APBI criteria 10. Subjects with completed breast conserving surgery (BCS) with or without sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND). 11. Suitable for APBI as deemed by the treating radiation oncologist 12. Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. 13. Enrollment in another clinical trial is allowed if there would be no interference with interventions on this trial Exclusion Criteria: 1. Pre- or post-operative systemic chemotherapy while on this study. 2. Current ongoing treatment with anti-hormonal agents. If previously on anti-hormonal agents and planning to stop, the subject must discontinue within 30 days of randomization. 3. Hormonal replacement therapy (eligible if discontinued within 30 days of randomization). 4. Multifocal or multicentric tumor. 5. Receipt of tissue rearrangement in the lumpectomy cavity. 6. Synchronous bilateral breast cancer. 7. Clinical or imaging evidence of distant metastases. 8. Prior breast or thoracic radiation. 9. Autoimmune conditions with associated radiation risks. 10. Subjects with poor medical risk due to uncontrolled medical conditions that would deem them ineligible for hormonal or radiation therapy.
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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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University of North Carolina
RECRUITINGChapel Hill, North Carolina, 27599, United States
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