Clinical trial NCT01208974: Nipple-Areola Complex (NAC) Irradiation After Nipple-Sparing Mastectomy and Reconstruction
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Ductal Carcinoma
Keywords: Breast Cancer
Nipple Area Complex
Mastectomy
Radiation Therapy
Nipple-Sparing
Breast Reconstruction
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2010-09-24
Enrollment: 21
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Phase 1 dose-escalation/de-escalation.
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Maximum Tolerated Dose (MTD) of Prophylactic NAC Irradiation.
timeFrame: Up to 13 weeks
Secondary outcomes:
measure: Cosmetic Outcome
timeFrame: 12 months
measure: Disease-Free Survival Rate in Study Participants
timeFrame: Up to 5 years
measure: Overall Survival Rate in Study Participants
timeFrame: Up to 5 years
measure: Recurrence Rate in Study Participants
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Sylvester Comprehensive Cancer Center
state: Florida
Study officials:
affiliation: University of Miami
name: Cristiane Takita, MD
role: PRINCIPAL_INVESTIGATOR
References: