Nipple-Areola Complex (NAC) Irradiation After Nipple-Sparing Mastectomy and Reconstruction
This study is currently recruiting participants.
(see Contacts and Locations)
Verified January 2015 by University of Miami
Sponsor:
University of Miami
Information provided by (Responsible Party):
Cristiane Takita, MD, University of Miami
ClinicalTrials.gov Identifier:
NCT01208974
First received: September 22, 2010
Last updated: January 30, 2015
Last verified: January 2015
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Breast Cancer Ductal Carcinoma |
Procedure: Nipple-Sparing Mastectomy Radiation: Prophylactic Nipple-Areolar Complex RT Procedure: Immediate Breast Reconstruction Procedure: Axillary surgery Drug: Chemotherapy |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
MedlinePlus related topics:
Breast Cancer
Breast Reconstruction
Mastectomy
Plastic and Cosmetic Surgery
U.S. FDA Resources
Further study details as provided by University of Miami:
Primary Outcome Measures:
- To determine the recommended phase II dose of post-operative prophylactic NAC irradiation. [ Time Frame: 3-5 Years ] [ Designated as safety issue: Yes ]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.
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 18 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | October 2016 |
| Estimated Primary Completion Date: | October 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Prophylactic Nipple-Areolar Complex RT
Nipple-Sparing Mastectomy + Axillary surgery + Immediate Breast Reconstruction + Prophylactic Nipple-Areolar Complex RT with or without Chemotherapy
|
Procedure: Nipple-Sparing Mastectomy
Nipple-Sparing Mastectomy with Immediate Breast Reconstruction followed by Prophylactic Nipple-Areolar Complex Radiation
Radiation: Prophylactic Nipple-Areolar Complex RT
Prophylactic NAC RT twice daily, for 5 days, preferable in consecutive working days.
Other Names:
Procedure: 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 Reconstruction
Procedure: Axillary surgery
At surgeon's discretion.
Drug: Chemotherapy
Chemotherapy, if indicated, at the discretion of the treating physician
Other Name: Systemic therapy
Radiation: Prophylactic Nipple-Areolar Complex RT
Nipple-sparing Mastectomy with Immediate Breast Reconstruction followed by Prophylactic Nipple-Areolar Complex Radiation
Other Names:
|
Detailed Description:
- 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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.
- 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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01208974
Please refer to this study by its ClinicalTrials.gov identifier: NCT01208974
Locations
| United States, Florida | |
| University of Miami Sylvester Comprehensive Cancer Center | Recruiting |
| Miami, Florida, United States, 33136 | |
| Contact: University of Miami Sylvester Comprehensive Cancer Center 866-574-5124 Sylvester@emergingmed.com | |
| Principal Investigator: Eli Avisar, MD | |
| Principal Investigator: Cristiane Takita, MD | |
| Sub-Investigator: Zubin Panthaki, MD | |
Sponsors and Collaborators
University of Miami
Investigators
| Principal Investigator: | Cristiane Takita, MD | University of Miami |
More Information
No publications provided
| Responsible Party: | Cristiane Takita, MD, Professor of Clinical, University of Miami |
| ClinicalTrials.gov Identifier: | NCT01208974 History of Changes |
| Other Study ID Numbers: | 20090299, SCCC-2009004 |
| Study First Received: | September 22, 2010 |
| Last Updated: | January 30, 2015 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Miami:
|
Breast Cancer Nipple Area Complex Mastectomy |
Radiation Therapy Nipple-Sparing Breast Reconstruction |
ClinicalTrials.gov processed this record on March 03, 2015