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Radiation may let breast cancer patients keep their nipple

NCT ID NCT01208974

Disease control Sponsor: University of Miami 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 13, 2026 · Last updated Aug 14, 2026 · Updated 1 time

Summary

This trial tests whether giving radiation to the nipple and areola after a nipple-sparing mastectomy is safe and feasible for women with early-stage breast cancer. The goal is to see if this extra radiation can reduce the risk of cancer returning in the preserved nipple area, allowing more patients to keep their natural appearance. The study will find the highest dose of radiation that causes minimal side effects and will also evaluate cosmetic outcomes and disease-free survival.

What this could mean

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

Active substance
Prophylactic radiation therapy to the nipple-areola complex after nipple-sparing mastectomy and immediate breast reconstruction
What this could lead to
If safe, this approach could allow more women with breast cancer to keep their nipple and areola after mastectomy, improving cosmetic outcomes without increasing cancer recurrence risk.
What could go wrong
This is a small early-phase trial focused on safety and dosing, so it may not confirm long-term benefits. Risks include skin reactions, nipple necrosis, and other radiation-related toxicities.

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

21 people

The number who actually took part.

Started

Mar 2010

Finished

May 2026

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: * Patients must have histologically confirmed in-situ or invasive breast carcinoma. * Tis, T1, T2 invasive or non-invasive carcinoma of the breast; lesion less than 4 cm. * Unifocal, multifocal or multicentric breast cancers that can be removed by nipple sparing mastectomy with negative surgical margins. * No extensive intraductal component or patient with distant metastases. * Patients must be \> 18 years of age. * No concomitant or history of nipple discharge or skin involvement. * No prior history of malignancy (less than 5 years prior to study entry), except non-melanomatous skin cancer. * No prior history of radiation to the chest. * No collagenous disease (systemic lupus erythematosis, scleroderma, dermatomyositis)No previous non-hormonal therapy including radiation or chemotherapy for current breast cancer. * No patients with Paget's disease of the nipple. * No patients with co-existing medical conditions with life expectancy \< 2 years. * No pregnant or lactating women. * Eastern Cooperative Oncology Group (ECOG) 0 - 2. * Signed study-specific informed consent form prior to the study entry. Exclusion Criteria: * Retroareolar breast cancer lesions within one cm, depth from the skin surface. * Concomitant or history of nipple discharge or skin involvement. * Patient with distant metastases. * Patient with extensive intraductal carcinoma. * Any previously irradiated ipsilateral breast cancer. * Patients with Paget's disease of the nipple. * Patients with collagenous diseases, as systemic lupus erythematosis, scleroderma or dermatomyositis. * Other malignancy, except nonmelanomatous skin cancer, less than 5 years prior to participation in this study. * Patients who are pregnant or lactating due to potential exposure of the fetus to RT and unknown effects of RT to lactating females. * Positive surgical margins following nipple sparing mastectomy.

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Conditions

The condition(s) this trial relates to.

breast cancer breast ductal adenocarcinoma breast neoplasm Carcinoma, Ductal ductal breast carcinoma in situ

As listed by the trial registrant

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

Breast cancer Ductal carcinoma

Contacts and locations

Locations

  • University of Miami Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136, United States

More trials for these conditions

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