Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial 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.
Phase
N/A
Funding Agency/Sponsor
Institutional
Disease
Breast Cancer
Enrollment Eligibility
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.