Nipple-Areola Complex (NAC) Irradiation After Nipple-Sparing Mastectomy and Reconstruction
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|ClinicalTrials.gov Identifier: NCT01208974|
Recruitment Status : Active, not recruiting
First Posted : September 24, 2010
Last Update Posted : October 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Ductal Carcinoma||Procedure: Nipple-Sparing Mastectomy Procedure: Breast Reconstruction Procedure: Axillary Surgery Radiation: Prophylactic Nipple-Areolar Complex RT||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||Phase 1 dose-escalation/de-escalation.|
|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|
|Actual Primary Completion Date :||February 13, 2018|
|Estimated Study Completion Date :||May 2022|
Experimental: Phase 1 MTD NAC RT
Participants will undergo a Nipple-Areolar Complex (NAC)-sparing mastectomy with immediate reconstruction and axillary surgery, if indicated, on Week 1. Anytime between Weeks 5-8, participants will undergo a dose-escalation/de-escalation of prophylactic NAC radiation treatment (RT) twice daily (minimum of 4 hours apart) for 5 days. Dose escalation/de-escalation design are as follows:
Participants will be treated between cohorts of 2-6 patients per dose level starting at dose level II. Dose escalation stops when 2 out of 2-6 participants encounter Dose Limiting Toxicities (DLT).
Standard of care chemotherapy, at treating physician's discretion, can be initiated 2 weeks after RT.
Procedure: Nipple-Sparing Mastectomy
Subcutaneous Mastectomy (SCM) to be performed, preserving the nipple and areola complex, after a frozen section of the tissue underneath the nipple-areola complex is sampled and found to be negative for tumor. Performed during Week 1.
Procedure: 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. Performed during Week 1.
Procedure: Axillary Surgery
Axillary Dissection or Sentinel Node Biopsy (SNB) will be performed at surgeon's discretion.
Radiation: Prophylactic Nipple-Areolar Complex RT
Prophylactic Nipple-Areolar Complex Radiation Therapy per protocol. Administered between weeks 5 to 8.
Other Name: Prophylactic NAC Radiation Therapy
- 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, among the doses tested, at which only 0 or 1 out of 6 participants experiences 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.
- Cosmetic Outcome [ Time Frame: 12 months ]Cosmetic Outcome will be reported as the number of participants in each of the 4 cosmetic outcome category ordinal scale. The 4 cosmetic outcome category scales are excellent, good, fair and poor. Both physician and patient's evaluation will be reported.
- Disease-Free Survival Rate in Study Participants [ Time Frame: Up to 5 years ]Disease-free survival rate in study participants will be assessed. Disease-free survival is defined from the date of surgery until the date of documented recurrence (local or distant) or breast cancer-related death, whichever occurs first. Patients who die without documentation of recurrence will be considered to have had disease recurrence at the time of death, unless there is documented evidence that no recurrence occurred before death.
- Overall Survival Rate in Study Participants [ Time Frame: Up to 5 years ]Overall Survival rate in study participants will be assessed. Overall survival is the defined from the date of surgery until the date of death due to any cause. In the absence of death, follow-up time will be censored by the date of last contact..
- Recurrence Rate in Study Participants [ Time Frame: Up to 5 years ]Rate of disease recurrence in study participants. The definition of local recurrence is histologic evidence of recurrent carcinoma, either invasive or non-invasive in the nipple-areola complex in the ipsilateral breast. Clinical evidence of carcinoma by physical exam and/or mammograms/MRI will not be evidence of local recurrence until biopsy proof.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01208974
|United States, Florida|
|University of Miami Sylvester Comprehensive Cancer Center|
|Miami, Florida, United States, 33136|
|Principal Investigator:||Cristiane Takita, MD||University of Miami|