Nipple-Areola Complex (NAC) Irradiation After Nipple-Sparing Mastectomy and Reconstruction

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of Miami
Sponsor:
Information provided by (Responsible Party):
Cristiane Takita, MD, University of Miami
ClinicalTrials.gov Identifier:
NCT01208974
First received: September 22, 2010
Last updated: July 25, 2014
Last verified: July 2014
  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:


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:
  • nipple sparing
  • nipple radiation
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:
  • Prophylactic Radiation
  • Nipple sparing
  • Nipple-Areolar Complex

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

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: July 25, 2014
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

Additional relevant MeSH terms:
Carcinoma, Ductal
Carcinoma, Ductal, Breast
Breast Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Ductal, Lobular, and Medullary
Neoplasms by Site
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 16, 2014