Delayed-Immediate Breast Reconstruction
This study is currently recruiting participants.
Verified April 2013 by M.D. Anderson Cancer Center
Sponsor:
M.D. Anderson Cancer Center
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
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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:
Genetics Home Reference related topics:
breast cancer
MedlinePlus related topics:
Breast Cancer
Breast Reconstruction
Cancer
Mastectomy
Plastic and Cosmetic Surgery
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:
- Patients with clinical stage I or stage II breast cancer who may require postmastectomy XRT.
- 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.
- Patients must sign the consent form and must be able to withstand two (2) anesthetic procedures.
- 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:
- Patients with stage III or stage IV breast cancer who are known preoperatively to require postmastectomy XRT.
- 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:
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 May 23, 2013