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

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New surgery could save the areola even when nipple cancer is found

NCT ID NCT07544134

Symptom relief Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new surgical approach for women with early breast cancer who need a nipple-sparing mastectomy. If cancer is found in the nipple during surgery, doctors will remove the nipple but try to save the pigmented skin around it (the areola) and rebuild a new nipple right away. The goal is to see if this is safe and leads to better-looking results and higher satisfaction. About 40-60 women will be followed for 3 years to check for cancer return and complications.

What this could mean

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

Active substance
Areola-preserving nipple-sparing mastectomy with immediate nipple reconstruction (surgical procedure)
What this could lead to
If successful, this could offer women a way to keep a more natural-looking breast after mastectomy, even when cancer is found in the nipple, improving self-image and quality of life.
What could go wrong
This is a very early, small pilot study with only 40-60 patients, so results may not apply to everyone. There is a risk of cancer returning in the preserved areola or complications like infection or tissue death.

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 40 people

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

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Jan 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

18 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. Female, age ≥ 18 years. 2. Pathologically confirmed primary invasive breast carcinoma or ductal carcinoma in situ (DCIS). 3. Clinical tumor stage cTis-2, N0-2, M0 (AJCC 8th Edition). 4. Planned for therapeutic nipple-sparing mastectomy (NSM) with immediate reconstruction. 5. Intraoperative frozen section confirms involvement of the nipple core tissue by invasive carcinoma or DCIS. 6. ECOG performance status 0-1. 7. Willing and voluntarily provide written informed consent. Exclusion Criteria: 1. Clinical or radiological suspicion of areola or skin involvement. 2. Inflammatory breast cancer. 3. Pregnancy or lactation. 4. Any severe medical or psychiatric condition that, in the investigator's judgment, would preclude safe participation or compliance. 5. Severe uncontrolled comorbidities with a life expectancy of less than 5 years.

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.

breast cancer breast neoplasm ductal breast carcinoma in situ invasive breast carcinoma

As listed by the trial registrant

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

Breast cancer Ductal carcinoma in situ, dcis Invasive breast carcinoma

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 Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310009, China

More trials for these conditions

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