Radiation may let breast cancer patients keep their nipple

NCT ID NCT01208974

Completed Disease control Sponsor: University of Miami Source: ClinicalTrials.gov ↗

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.

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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

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