Delayed-Immediate Breast Reconstruction

This study has been completed.
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: September 1, 2015
Last verified: September 2015
  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 Phase
Breast Cancer
Procedure: Delayed-Immediate Breast Reconstruction
Phase 2

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:


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 ]
    Patient data and photographs gathered throughout the various stages of delayed-immediate reconstruction, during routine preoperative, intraoperative, and postoperative examinations. Details of primary disease include preoperative tumor stage, method of breast cancer diagnosis, tumor biologic characteristics, and the use of neoadjuvant chemotherapy. Preoperative and postoperative tumor stage compared to evaluate the indications for the delayed-immediate approach to breast reconstruction.


Secondary Outcome Measures:
  • Compare Aesthetic Outcomes for Immediate-Delayed Breast Reconstruction [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
    System used for aesthetic analysis is a four-point scale used to evaluate the aesthetic outcomes: excellent (4); good (3); fair (2); or poor (1). Results considered "excellent" when patient had almost perfect shape of the reconstructed breast and perfect contralateral breast symmetry, "good" when patient had imperfect shape of the reconstructed breast and imperfect contralateral symmetry but within normal limits, "fair" when patient had some contralateral asymmetry but a reasonably normal breast, and "poor" when patient had unacceptable shape and symmetry.


Enrollment: 200
Study Start Date: April 2005
Primary Completion Date: August 2015 (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 University of Texas MD Anderson Cancer Center (UT 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
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: NCT00473122

Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
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:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00473122     History of Changes
Other Study ID Numbers: 2004-0955, NCI-2012-02091, BCTR0503938
Study First Received: May 10, 2007
Last Updated: September 1, 2015
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

ClinicalTrials.gov processed this record on September 03, 2015