Status:
COMPLETED
Delayed-Immediate Breast Reconstruction
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Susan G. Komen Breast Cancer Foundation
Conditions:
Breast Cancer
Eligibility:
FEMALE
Phase:
PHASE2
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....
Detailed Description
In women who have a mastectomy and desire breast reconstruction, the best timing of breast reconstruction depends on whether radiation therapy (XRT) is needed. If XRT is not needed, immediate reconstr...
Eligibility Criteria
Inclusion
- 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 University of Texas MD Anderson Cancer Center (UT 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
- 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.
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00473122
Start Date
April 1 2005
End Date
August 1 2015
Last Update
July 15 2016
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030