Breast Cancer Clinical Trial

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

Summary

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.

View Eligibility Criteria

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.

Study is for people with:

Breast Cancer

Estimated Enrollment:

21

Study ID:

NCT01208974

Recruitment Status:

Active, not recruiting

Sponsor:

University of Miami

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There is 1 Location for this study

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University of Miami Sylvester Comprehensive Cancer Center
Miami Florida, 33136, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

21

Study ID:

NCT01208974

Recruitment Status:

Active, not recruiting

Sponsor:


University of Miami

How clear is this clinincal trial information?

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