NCT01002014

Brief Summary

The purpose of this study is to observe the cosmetic outcomes, patient satisfaction, and complications after skin sparing mastectomy with preservation of the nipple areolar complex.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Jan 2009

Longer than P75 for not_applicable breast-cancer

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

January 21, 2009

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 27, 2009

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 24, 2016

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2018

Completed
Last Updated

April 21, 2022

Status Verified

January 1, 2019

Enrollment Period

7.6 years

First QC Date

October 26, 2009

Last Update Submit

April 19, 2022

Conditions

Breast CancerBreast ReconstructionCosmesis

Keywords

Breast CancerSkin Sparing MastectomyBreast Cancer ProphylaxisNipple Sparing MastectomyNipple Areolar ComplexMastectomyBreast ReconstructionLocal recurrence following nipple sparing mastectomyCosmetic outcomes following nipple sparing mastectomyComplications following nipple sparing mastectomy

Outcome Measures

Primary Outcomes (4)

  • Cosmetic Appearance

    First Post Operative year

  • Patient Satisfaction

    First Post Operative Year

  • Presence of tumor in nipple areolar complex frozen section

    Duration of Study

  • Presence of tumor in nipple areolar complex permanent histology

    Duration of study

Secondary Outcomes (2)

  • Complications

    First Post Operative year

  • Local Recurrence

    One year

Study Arms (1)

Nipple Sparing Mastectomy

EXPERIMENTAL

Patients who undergo nipple sparing mastectomy with preservation of the nipple areolar complex.

Procedure: Nipple Sparing Mastectomy

Interventions

Nipple Sparing MastectomyPROCEDURE

Skin sparing mastectomy with preservation of the nipple areolar complex

Nipple Sparing Mastectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients requiring mastectomy for cancer and/or prophylaxis
  • Age greater than or equal to 18 at time of surgery
  • BMI less than or equal to 35
  • If mastectomy is indicated for removal of breast cancer, tumor is clinically T1 or T2

You may not qualify if:

  • Currently smoking
  • Prior radiation to the affected breast
  • Systemic lupus erythematosus
  • Central tumor location and/or tumor within 2 cm of NAC
  • Paget's disease of the nipple
  • Clinical evidence of tumor involvement in the nipple
  • Clinical evidence of axillary nodal tumor involvement
  • Lymphovascular invasion of the tumor on core biopsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

Location

Related Publications (13)

  • Vlajcic Z, Zic R, Stanec S, Lambasa S, Petrovecki M, Stanec Z. Nipple-areola complex preservation: predictive factors of neoplastic nipple-areola complex invasion. Ann Plast Surg. 2005 Sep;55(3):240-4. doi: 10.1097/01.sap.0000171680.49971.85.

    PMID: 16106159BACKGROUND

  • Crowe JP, Patrick RJ, Yetman RJ, Djohan R. Nipple-sparing mastectomy update: one hundred forty-nine procedures and clinical outcomes. Arch Surg. 2008 Nov;143(11):1106-10; discussion 1110. doi: 10.1001/archsurg.143.11.1106.

    PMID: 19015470BACKGROUND

  • Crowe JP Jr, Kim JA, Yetman R, Banbury J, Patrick RJ, Baynes D. Nipple-sparing mastectomy: technique and results of 54 procedures. Arch Surg. 2004 Feb;139(2):148-50. doi: 10.1001/archsurg.139.2.148.

    PMID: 14769571BACKGROUND

  • Sacchini V, Pinotti JA, Barros AC, Luini A, Pluchinotta A, Pinotti M, Boratto MG, Ricci MD, Ruiz CA, Nisida AC, Veronesi P, Petit J, Arnone P, Bassi F, Disa JJ, Garcia-Etienne CA, Borgen PI. Nipple-sparing mastectomy for breast cancer and risk reduction: oncologic or technical problem? J Am Coll Surg. 2006 Nov;203(5):704-14. doi: 10.1016/j.jamcollsurg.2006.07.015. Epub 2006 Sep 11.

    PMID: 17084333BACKGROUND

  • Stolier AJ, Sullivan SK, Dellacroce FJ. Technical considerations in nipple-sparing mastectomy: 82 consecutive cases without necrosis. Ann Surg Oncol. 2008 May;15(5):1341-7. doi: 10.1245/s10434-007-9753-5. Epub 2008 Feb 7.

    PMID: 18256883BACKGROUND

  • Wijayanayagam A, Kumar AS, Foster RD, Esserman LJ. Optimizing the total skin-sparing mastectomy. Arch Surg. 2008 Jan;143(1):38-45; discussion 45. doi: 10.1001/archsurg.143.1.38.

    PMID: 18209151BACKGROUND

  • Banerjee A, Gupta S, Bhattacharya N. Preservation of nipple-areola complex in breast cancer--a clinicopathological assessment. J Plast Reconstr Aesthet Surg. 2008 Oct;61(10):1195-8. doi: 10.1016/j.bjps.2007.08.005. Epub 2007 Sep 27.

    PMID: 17901007BACKGROUND

  • Loewen MJ, Jennings JA, Sherman SR, Slaikeu J, Ebrom PA, Davis AT, Fitzgerald TL. Mammographic distance as a predictor of nipple-areola complex involvement in breast cancer. Am J Surg. 2008 Mar;195(3):391-4; discussion 394-5. doi: 10.1016/j.amjsurg.2007.12.020.

    PMID: 18207131BACKGROUND

  • Laronga C, Kemp B, Johnston D, Robb GL, Singletary SE. The incidence of occult nipple-areola complex involvement in breast cancer patients receiving a skin-sparing mastectomy. Ann Surg Oncol. 1999 Sep;6(6):609-13. doi: 10.1007/s10434-999-0609-z.

    PMID: 10493632BACKGROUND

  • Gerber B, Krause A, Reimer T, Muller H, Kuchenmeister I, Makovitzky J, Kundt G, Friese K. Skin-sparing mastectomy with conservation of the nipple-areola complex and autologous reconstruction is an oncologically safe procedure. Ann Surg. 2003 Jul;238(1):120-7. doi: 10.1097/01.SLA.0000077922.38307.cd.

    PMID: 12832974BACKGROUND

  • Fitzal F. Can nipple-sparing mastectomy and immediate breast reconstruction with modified extended latissimus dorsi muscular flap improve the cosmetic and functional outcome of patients with breast cancer? World J Surg. 2008 Mar;32(3):499; author reply 500-1. doi: 10.1007/s00268-007-9268-z. No abstract available.

    PMID: 17952495BACKGROUND

  • Carlson GW, Losken A, Moore B, Thornton J, Elliott M, Bolitho G, Denson DD. Results of immediate breast reconstruction after skin-sparing mastectomy. Ann Plast Surg. 2001 Mar;46(3):222-8. doi: 10.1097/00000637-200103000-00003.

    PMID: 11293510BACKGROUND

  • Lowery JC, Wilkins EG, Kuzon WM, Davis JA. Evaluations of aesthetic results in breast reconstruction: an analysis of reliability. Ann Plast Surg. 1996 Jun;36(6):601-6; discussion 607. doi: 10.1097/00000637-199606000-00007.

    PMID: 8792969BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mastectomy, Subcutaneous

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

MastectomySurgical Procedures, Operative

Study Officials

  • Richard L White, MD

    Carolinas Healthcare

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2009

First Posted

October 27, 2009

Study Start

January 21, 2009

Primary Completion

August 24, 2016

Study Completion

September 20, 2018

Last Updated

April 21, 2022

Record last verified: 2019-01

Locations

US(1)