NCT00539227

Brief Summary

The goal of this study is to study nipple-areolar complex (NAC) sparing mastectomy as an alternative procedure to the standard skin-sparing mastectomy for women who have breast cancer or are at high-risk for developing breast cancer. You have been asked to take part in this study because your treating surgeon feels you are a candidate for skin-sparing mastectomy and because you want breast reconstruction after surgery. Outcomes that will be measured include how much nipple sensation can be kept after surgery; how satisfied you are with how the breast looks after surgery; complication rates; and your quality-of-life.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 2, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 4, 2007

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

August 26, 2013

Status Verified

August 1, 2013

Enrollment Period

5.8 years

First QC Date

October 2, 2007

Last Update Submit

August 23, 2013

Conditions

Breast Cancer

Keywords

Breast CancerNipple-Areolar ComplexMastectomyProphylactic mastectomyImmediate reconstructionReconstructive surgeryQuestionnaireSurveyNAC

Outcome Measures

Primary Outcomes (1)

  • Nipple Sensation Evaluation (following NAC sparing mastectomy)

    Within first month postoperatively, then at 3 months, 6 month, 1 year, 2 years, and 5 years postoperatively (each interval +/- 1 month)

Study Arms (1)

NAC Sparing Mastectomy

A skin-sparing mastectomy performed with preservation of the nipple-areolar complex (NAC). Questionnaires taking about 20-30 minutes to complete.

Procedure: NAC Sparing MastectomyBehavioral: Questionnaire

Interventions

NAC Sparing MastectomyPROCEDURE

A skin-sparing mastectomy performed with preservation of the nipple-areolar complex (NAC).

NAC Sparing Mastectomy
QuestionnaireBEHAVIORAL

Questionnaires taking about 20-30 minutes to complete.

Also known as: Survey
NAC Sparing Mastectomy

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with breast cancer.

You may qualify if:

  • Patients desiring prophylactic mastectomy with immediate reconstruction
  • Patients with Stage 0, I, or II breast cancer who are candidates for and desire skin-sparing mastectomy with immediate reconstruction
  • Tumor location greater than or equal to 2.5 cm from the border of the NAC based on preoperative imaging and/or clinical exam
  • Patients must sign an informed consent and be registered before the procedure is performed

You may not qualify if:

  • Patients with cancer involvement of the NAC on clinical exam, defined as induration, retraction, fixation, ulceration, or pathologic nipple discharge
  • Patients with subareolar tumor locations, tumors located \< 2.5 cm from the border of the NAC
  • Patients with Paget's disease of the nipple
  • Patients who have locally advanced breast cancer manifesting as inflammatory breast cancer or gross involvement of the mastectomy skin
  • Patients with history of prior surgery involving a periareolar incision
  • Patients desiring a concomitant ipsilateral reduction mammoplasty at time of mastectomy
  • Patients with macromastia as defined by the plastic surgeon
  • Patients with a body mass index (BMI) greater than 40 kg/m2
  • Patients who actively smoke
  • Patients with known collagen vascular disease
  • Patients with prior ipsilateral chest wall irradiation less than 12 months from their time of surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Gildy V. Babiera, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2007

First Posted

October 4, 2007

Study Start

October 1, 2007

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

August 26, 2013

Record last verified: 2013-08

Locations

US(1)