A Phase I Trial Assessing the Safety and Feasibility of Prophylactic Nipple-Areola Complex (NAC) Irradiation After Nipple-Sparing Mastectomy and Immediate Reconstruction in Patients With In-Situ or Invasive Breast Cancer

University of Miami1 site in 1 country21 target enrollmentMarch 16, 2010

ConditionsBreast Cancer Ductal Carcinoma

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Breast Cancer
Sponsor: University of Miami
Enrollment: 21
Locations: 1
Primary Endpoint: Maximum Tolerated Dose (MTD) of Prophylactic NAC Irradiation.
Status: Active, not recruiting
Last Updated: 10 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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 reconstruction.

Registry

clinicaltrials.gov

Start Date

March 16, 2010

End Date

May 31, 2026

Last Updated

10 months ago

Study Type

Interventional

Study Design

Sequential

Sex

Female

Investigators

Sponsor

University of Miami

Responsible Party

Principal Investigator

Cristiane Takita

Professor of Clinical

University of Miami

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.

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.

Outcomes

Primary Outcomes

Maximum Tolerated Dose (MTD) of Prophylactic NAC Irradiation.

Time Frame: Up to 13 weeks

The recommended Phase II dose will be reported as the MTD at which only 0 or 1 out of 6 participants experiences dose limiting toxicity (DLT). DLT will be reported as any of the following: Grade 4 skin rash or pain, NAC necrosis, any toxicity requiring interruption of NAC irradiation greater than 2 weeks or any grade 4 or 5 treatment related toxicity. Toxicity will be evaluated by treating physician using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 3.0.