Radiation alone may spare older breast cancer patients from hormone therapy side effects
NCT ID NCT06897488
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether giving only radiation after lumpectomy is safe and effective for women aged 60 and older with early-stage, low-risk breast cancer. The goal is to see if skipping hormone therapy can improve quality of life while still controlling the cancer. About 300 participants will be followed for side effects and disease outcomes.
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 300 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Dec 2030
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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60 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. Diagnosis of pathologically-confirmed invasive breast cancer 2. Age ≥ 60 years 3. Treatment with breast conserving surgery 4. Pathologic T stage of T1 or T2 with total tumor size ≤ 3cm including any component of DCIS that may exist in conjunction with invasive disease 5. Ki-67 . 20% and/or Oncotype 0-10 (Ultra Low) 6. Final surgical margins negative, defined as no tumor on ink. Lobular carcinoma in situ involving the final surgical margin will be disregarded. 7. Tumor must be estrogen receptor positive, progesterone receptor positive and HER2Neu non-amplified as per current College of American Pathologists guidelines 8. Clinical nodal stage cN0 9. If pathologic nodal staging is obtained, then pN0 or pN0(i+) 10. Patients have had or have a scheduled discussion with a breast medical oncologist regarding adjuvant treatment options 11. Patients who have met criteria 4.1.1-4.1.9 who never initiate endocrine therapy OR who initiate adjuvant endocrine therapy but discontinue it within 6 months of initiation \* In some clinical scenarios, patients may have a particularly small volume of tumor, making it not be feasible for all of these biomarkers to be evaluated. In this scenario, if the PI and/or Protocol Collaborators are able to document that a patient is being treated as if they have luminal A (biologically favorable) breast cancer then the patient is eligible for enrollment if all other eligibility criteria are met. Exclusion Criteria: 1. Node positive disease (N1-3) 2. Metastatic disease (M1) 3. Grade 3 disease and lymphovascular space invasion in the tumor 4. Synchronous bilateral breast cancer 5. Receipt of neoadjuvant therapy 6. Diagnosis of a collagen vascular disease associated with an increased incidence of radiation toxicities such as scleroderma or systemic lupus erythematosis 7. Diagnosis of other cancer within the prior 5 years, excluding basal or squamous cell carcinoma of the skin that has been treated 8. Patient with psychiatric illness/social situations that would limit compliance with study requirements 9. Prior radiotherapy to the index breast or recurrent cancer of the breast 10. Known carrier of a mutation associated with predisposition to breast cancer development, including BRCA1 or BRCA2
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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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The University of Texas M. D. Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
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