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Surgery-free breast cancer treatment tested in new trial

NCT ID NCT07245316

Disease control Sponsor: Jeong Eon Lee Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 is testing whether people with certain non-invasive or early breast conditions (like ductal carcinoma in situ) can safely skip surgery and instead take hormone-blocking medication. The goal is to see if this approach keeps cancer from coming back over five years. The trial will enroll 340 women whose biopsy shows hormone-sensitive, HER2-negative disease.

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 (hormone-blocking medication)
What this could lead to
If successful, this could offer a way to manage certain early breast conditions with medication alone, avoiding the need for surgery.
What could go wrong
This is an early-stage study without a control group, so results may not confirm that skipping surgery is safe. There is a risk that cancer could return or progress without surgical removal.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 340 people

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

Expected to start

Dec 2025

An estimate. Start dates often move.

Expected to finish

Dec 2032

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

35 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.

1\. Inclusion criteria: 1. Female patients aged ≥35 years. 2. Diagnosed with atypical ductal hyperplasia (ADH), ductal carcinoma in situ (DCIS), or lobular carcinoma in situ (LCIS) on core-needle biopsy, vacuum-assisted biopsy, or excisional biopsy. 3. Immunohistochemistry (IHC) performed on biopsy specimens confirming estrogen receptor (ER), progesterone receptor (PR), and HER2 status; eligible only if the ER Allred total score is ≥7 and HER2 status is negative. 4. All low- and intermediate-grade nuclear grades included; for high-grade lesions, only patients with a Ki-67 index ≤20% are eligible. 5. Lesion not definitely palpable on physical examination at diagnosis. 6. No prior breast surgery for ipsilateral or contralateral breast cancer, and no synchronous contralateral breast cancer. 7. Not diagnosed with pregnancy-associated breast cancer or breast cancer detected during lactation. 8. Negative serum or urine β-hCG prior to enrollment. 9. Provided written informed consent to participate in the study. 2\. Exclusion criteria: 1. Pregnant patients. 2. Patients with clinically significant psychiatric disorders (e.g., major depressive disorder) or those currently receiving psychiatric or antipsychotic medications. 3. Concomitant diagnosis of invasive breast cancer. 4. Evidence of axillary lymph node metastasis. 5. Carriers of BRCA1/2 mutations. 6. Male patients. 7. History of diagnosis or treatment for breast cancer. 8. Presence or history of other malignancies besides breast cancer. 9. Concomitant diagnosis of pleomorphic LCIS.

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Conditions

The condition(s) this trial relates to.

breast intraductal proliferative lesion ductal breast carcinoma in situ lobular breast carcinoma in situ invasive breast carcinoma prevention target

As listed by the trial registrant

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

Ductal carcinoma in situ of the breast

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

  • Samsung Medical Center

    Seoul, South Korea

More trials for these conditions

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