Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Radiation alone may spare older breast cancer patients from hormone therapy side effects

NCT ID NCT06897488

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Dec 2030

An estimate. End dates often move.

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

60 years and older

Sex

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

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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Breast cancer are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • The University of Texas M. D. Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.