Nipple-Areola Complex (NAC) Irradiation After Nipple-Sparing Mastectomy and Reconstruction
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|ClinicalTrials.gov Identifier: NCT01208974|
Recruitment Status : Recruiting
First Posted : September 24, 2010
Last Update Posted : October 2, 2017
Overall rationale: Prophylactic NAC irradiation after nipple-areola sparing mastectomy and immediate reconstruction for patient with ductal carcinoma in-situ or invasive breast cancer will allow better cosmesis and patient's satisfaction.
Study design: Phase I trial assessing the safety, feasibility and toxicity of prophylactic NAC irradiation after nipple-areola sparing mastectomy and immediate reconstruction in patients with ductal carcinoma in-situ or invasive breast cancer.
Primary objective: To determine the recommended phase I dose of post-operative prophylactic NAC irradiation.
Secondary objectives: To provide extensive descriptive data regarding NAC-sparing surgery with reconstruction, including both surgeon experience and patient evaluation of cosmetic results. Survival and recurrence will be assessed.
Study size: Between 12 and 18 patients will be enrolled in this phase I study.
|Condition or disease||Intervention/treatment|
|Breast Cancer Ductal Carcinoma||Procedure: Nipple-Sparing Mastectomy Procedure: Immediate Breast Reconstruction Procedure: Axillary surgery Radiation: Prophylactic Nipple-Areolar Complex RT|
- The use of NAC-sparing mastectomy followed by postoperative NAC (nipple-areola complex) external beam radiotherapy for selected patient with early stage invasive or in-situ breast cancers will be technically feasible and with acceptable complication rates.
- The cosmetic results after NAC-sparing mastectomy followed by postoperative external beam radiotherapy to the NAC will be better comparable with Skin Sparing Mastectomy.
- The local control rate in the NAC will be more than expected for a NAC sparing mastectomy without postoperative radiotherapy.
- The patient's satisfaction after NAC-sparing mastectomy followed by postoperative NAC external beam radiotherapy will be better than after Skin Sparing Mastectomy.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||March 16, 2010|
|Estimated Primary Completion Date :||April 2018|
|Estimated Study Completion Date :||April 2019|
Experimental: Prophylactic Nipple-Areolar Complex RT
Procedure: Nipple-Sparing Mastectomy
Nipple-Sparing Mastectomy with Immediate Breast Reconstruction followed by Prophylactic Nipple-Areolar Complex RadiationProcedure: Immediate Breast Reconstruction
Immediate reconstruction of the breast will be performed (after Nipple-Sparing Mastectomy) by the plastic surgeon, type depend on surgeon's discretion and patient's desire.
Other Name: Breast ReconstructionProcedure: Axillary surgery
At surgeon's discretion.Radiation: Prophylactic Nipple-Areolar Complex RT
Nipple-sparing Mastectomy with Immediate Breast Reconstruction followed by Prophylactic Nipple-Areolar Complex Radiation
- To determine the recommended phase II dose of post-operative prophylactic NAC irradiation. [ Time Frame: 3-5 Years ]The recommended phase II dose will be the highest irradiation dose level at which <= 1 out of 6 study patients experiences dose-limiting toxicity (DLT). This dose will be the phase dose II of post-operative prophylactic NAC irradiation after NAC-sparing mastectomy with reconstruction in patients with ductal carcinoma in-situ or invasive breast cancer.
- To provide extensive descriptive data regarding NAC-sparing surgery with reconstruction, including both surgeon experience and patient evaluation of cosmetic results. [ Time Frame: Up to 5 Years ]
Surgery success rate, defined as the proportion of patients who had successful NAC sparing surgery with reconstruction divided by the total number of study patients, will be determined.
Cosmetic results will be assessed by both the physician(s) and the patients at 3, 6 and 12 months, using a 4-category ordinal scale (excellent, good, fair, and poor).
- Survival [ Time Frame: Up to 5 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01208974
|United States, Florida|
|University of Miami Sylvester Comprehensive Cancer Center||Recruiting|
|Miami, Florida, United States, 33136|
|Contact: Cristiane Takita, MD firstname.lastname@example.org|
|Principal Investigator: Eli Avisar, MD|
|Principal Investigator: Cristiane Takita, MD|
|Sub-Investigator: Zubin Panthaki, MD|
|Principal Investigator:||Cristiane Takita, MD||University of Miami|