Status:
ACTIVE_NOT_RECRUITING
Nipple-Areola Complex (NAC) Irradiation After Nipple-Sparing Mastectomy and Reconstruction
Lead Sponsor:
University of Miami
Conditions:
Breast Cancer
Ductal Carcinoma
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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 reco...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 16 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2026
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01208974
Start Date
March 16 2010
End Date
May 31 2026
Last Update
June 26 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136