A Pilot Study to Evaluate Nipple-Areolar Complex (NAC) Sparing Mastectomy - Full Text View

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00539227

Purpose

Primary Objectives:

To prospectively evaluate the feasibility of nipple-areolar complex (NAC) sparing mastectomy as an alternative procedure to skin-sparing mastectomy for patients with a diagnosis of breast cancer or who are at high risk for developing breast cancer, by measuring nipple sensation, cosmetic outcomes and complication rates.
To evaluate local recurrence rates and quality of life in patients undergoing of NAC-sparing mastectomy.
To further investigate which factors may be correlated with neoplastic NAC involvement, such as primary tumor size, concomitant DCIS, nuclear grade, histologic subtype, tumor distance from the NAC and overlying skin, and axillary lymph node involvement.

Condition	Intervention
Breast Cancer	Procedure: NAC Sparing Mastectomy Behavioral: Questionnaire

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Mastectomy

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Prospective
Official Title:	A Pilot Study to Evaluate Nipple-Areolar Complex (NAC) Sparing Mastectomy

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

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. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	30
Study Start Date:	October 2007
Estimated Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 Patients with breast cancer.	Procedure: NAC Sparing Mastectomy A skin-sparing mastectomy will be performed with preservation of the nipple-areolar complex (NAC). Behavioral: Questionnaire Questionnaires taking about 20-30 minutes to complete.

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Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients with breast cancer.

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00539227

Contacts

Contact: Gildy V. Babiera, MD

713-792-6940

Locations

United States, Texas
U.T.M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Gildy V. Babiera, MD

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Gildy V. Babiera, MD

U.T.M.D. Anderson Cancer Center

More Information

MD Anderson Cancer Center This link exits the ClinicalTrials.gov site

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Gildy V. Babiera, MD/Associate Professor )
Study ID Numbers:	2007-0194
Study First Received:	October 2, 2007
Last Updated:	January 5, 2009
ClinicalTrials.gov Identifier:	NCT00539227
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Breast Cancer
Nipple-Areolar Complex
Mastectomy
Prophylactic mastectomy
Immediate reconstruction

Reconstructive surgery
Questionnaire
Survey
NAC

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009