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Nipple-Areola Complex (NAC) Irradiation After Nipple-Sparing Mastectomy and Reconstruction

NCT01208974

CompletedNA

Sponsor: University of Miami

Conditions: Breast Cancer, Ductal Carcinoma

Interventions: Nipple-Sparing Mastectomy, Breast Reconstruction, Axillary Surgery, Prophylactic Nipple-Areolar Complex RT

Countries: United States

The purpose of this research study is to see if a participant's nipple and areola can be safely preserved by adding radiation to these areas after a nipple-sparing mastectomy and immediate breast reconstruction.

Eligibility overview

Sex: FEMALE

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (1)

Miami, Florida, United States