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Could a 3-Month pill course spare older breast cancer patients from radiation?

NCT ID NCT06507618

Disease control Sponsor: University of Virginia Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jul 01, 2026 · Updated 3 times

Summary

This Phase III trial is for women aged 65 and older with early-stage, hormone-sensitive breast cancer. Half will take hormone-blocking pills for three months before surgery, while the other half will proceed directly to surgery as usual. The goal is to see if the pre-surgery pills help women feel more confident about skipping radiation therapy afterward. The study will track how well women tolerate the pills and whether they stick with the treatment plan.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
endocrine therapy (tamoxifen, letrozole, anastrozole, or exemestane)
What this could lead to
If successful, this approach could help older women with early breast cancer avoid unnecessary radiation therapy by using a short course of hormone-blocking pills before surgery.
What could go wrong
This is a Phase III trial, but it focuses on decision-making and adherence, not on curing cancer. The results may not apply to younger women or those with more aggressive tumors. Side effects from endocrine therapy can include hot flashes, joint pain, and fatigue.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 354 people

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

Started

Jul 2024

Expected to finish

Mar 2034

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

65 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 (summary): * Diagnosis of ER+, PR +/-, and HER2- non amplified invasive breast cancer and clinically negative nodes * ECOG performance status 0-2 * Females, aged ≥ 65 years * Patient is eligible for BCS and opted for BCS * Patient is a candidate for radiation therapy * Patient is a candidate for endocrine therapy (tamoxifen or an aromatase inhibitor) * Ability to take oral medication and be willing to adhere to endocrine therapy for the 3-month period prior to BCS * Agreement to adhere to Lifestyle Considerations (details in protocol) throughout study duration * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study Exclusion Criteria: * Bilateral synchronous breast cancer * Multicentric disease * Prior use of Tamoxifen or aromatase inhibitors * History of ipsilateral breast radiation therapy * Has a known additional malignancy that is progressing and/or requires active treatment with cytotoxic chemotherapy or radiation therapy. Malignancies deemed stable and low risk for complication per investigator's judgment may be allowed after discussion with multi-site PI. * Current or planned use of a strong CYP2D6 inhibitor (e.g., Fluvoxamine, Paroxetine) and is not able to receive an endocrine therapy agent that does not use the CYP2D6 pathway.

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Conditions

The condition(s) this trial relates to.

breast neoplasm estrogen-receptor positive breast cancer female breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer female

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    6 sites. 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

  • INOVA Schar Cancer

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Riverside Health System

    RECRUITING

    Newport News, Virginia, 23601, United States

  • University of Virginia

    RECRUITING

    Charlottesville, Virginia, 22903, United States

  • University of Virginia Community Health

    RECRUITING

    Culpeper, Virginia, 22701, United States

  • Virginia Commonwealth University

    RECRUITING

    Richmond, Virginia, 23298, United States

  • Yale University

    RECRUITING

    New Haven, Connecticut, 06511, United States

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