Text Size
Trial record 2 of 55 for:    Mammaplasty | Open Studies
Previous Study | Return to List | Next Study

Delayed-Immediate Breast Reconstruction

This study is currently recruiting participants.
Verified April 2013 by M.D. Anderson Cancer Center
Sponsor:
Collaborator:
Susan G. Komen Breast Cancer Foundation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00473122
First received: May 10, 2007
Last updated: April 11, 2013
Last verified: April 2013
History of Changes
  Purpose

The goal of this clinical research study is to evaluate a new two-stage approach (delayed-immediate reconstruction) to breast reconstruction in women who may require post-mastectomy radiation therapy. Researchers will compare the cosmetic outcomes and any complications that occur in women who receive delayed-immediate reconstruction to those who receive the standard approaches (either immediate reconstruction or delayed breast reconstruction).


Condition Intervention
Breast Cancer
 Procedure: Delayed-Immediate Breast Reconstruction

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Delayed-Immediate Breast Reconstruction

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Efficacy of Delayed-Immediate Breast Reconstruction [ Time Frame: 5 Years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Compare Aesthetic Outcomes for Immediate-Delayed Breast Reconstruction [ Time Frame: 5 Years ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: April 2005
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Delayed-Immediate Breast Reconstruction
Delayed-Immediate Reconstruction: If XRT is not needed, immediate reconstruction. If XRT is needed, delayed reconstruction until XRT is complete.
 Procedure: Delayed-Immediate Breast Reconstruction
Delayed-Immediate Reconstruction: If XRT is not needed, immediate reconstruction. If XRT is needed, delayed reconstruction until XRT is complete.

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with clinical stage I or stage II breast cancer who may require postmastectomy XRT.
  2. Patients will be required to receive postmastectomy XRT as well as breast reconstructive procedures, including subsequent deflation and re-inflation of the prosthesis after XRT at MDACC.
  3. Patients must sign the consent form and must be able to withstand two (2) anesthetic procedures.
  4. Patients with stage I breast cancer who will be eligible for delayed-immediate breast reconstruction will have extensive microcalcifications within the affected by mammography that make it difficult to determine preoperatively the extent of invasive disease.

Exclusion Criteria:

  1. Patients with stage III or stage IV breast cancer who are known preoperatively to require postmastectomy XRT.
  2. Patients with stage I breast cancer who are unlikely to require postmastectomy XRT.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00473122

Contacts
Contact: Steven J. Kronowitz, MD 713-792-7300

Locations
United States, Texas
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Steven J. Kronowitz, MD            
Sponsors and Collaborators
M.D. Anderson Cancer Center
Susan G. Komen Breast Cancer Foundation
Investigators
Principal Investigator: Steven J. Kronowitz, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
UT MD Anderson Cancer Center  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00473122     History of Changes
Other Study ID Numbers: 2004-0955
Study First Received: May 10, 2007
Last Updated: April 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Breast Cancer
Breast Reconstruction
Delayed-Immediate Reconstruction
 Postmastectomy Radiation Therapy
Mastectomy
XRT

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on June 18, 2013