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Delayed-Immediate Breast Reconstruction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00473122
Recruitment Status : Completed
First Posted : May 14, 2007
Last Update Posted : July 15, 2016
Susan G. Komen Breast Cancer Foundation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
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 or disease Intervention/treatment Phase
Breast Cancer Procedure: Delayed-Immediate Breast Reconstruction Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Delayed-Immediate Breast Reconstruction
Study Start Date : April 2005
Primary Completion Date : August 2015
Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Delayed-Immediate Breast Reconstruction
Delayed-Immediate Reconstruction: If radiation therapy (XRT) not needed, immediate reconstruction. If XRT is needed, delayed reconstruction until XRT complete.
Procedure: Delayed-Immediate Breast Reconstruction
Immediate reconstruction surgery if no XRT required; or reconstruction surgery delayed until XRT complete.

Primary Outcome Measures :
  1. Efficacy of Delayed-Immediate Breast Reconstruction [ Time Frame: 5 Years ]
    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 :
  1. Compare Aesthetic Outcomes for Immediate-Delayed Breast Reconstruction [ Time Frame: 5 Years ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00473122

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
Principal Investigator: Steven J. Kronowitz, MD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00473122     History of Changes
Other Study ID Numbers: 2004-0955
NCI-2012-02091 ( Registry Identifier: NCI CTRP )
BCTR0503938 ( Other Identifier: Susan G. Komen Breast Cancer Foundation )
First Posted: May 14, 2007    Key Record Dates
Last Update Posted: July 15, 2016
Last Verified: July 2016

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