Delayed-Delayed Breast Reconstruction

Completed · Not applicable

Conditions studied: Breast Cancer

In brief

The goal of this clinical research study is to learn if delayed-delayed breast reconstruction in women who require post-mastectomy radiation therapy will improve cosmetic outcomes and result in fewer complications compared to the standard approach (reconstruction that is not started until radiation treatment is completed).

Key facts

Study ID

NCT01256528

Run by

M.D. Anderson Cancer Center

People needed

40

Starts

2010-12-01

Expected to finish

2015-09-01

Last updated by the study team

2016-07-15

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Patients with invasive breast carcinoma that are scheduled for a mastectomy with planned postmastectomy XRT. This includes, but is not limited to, clinical stage II, III, and IV.
• Patient must desire breast reconstruction.
• Patients must sign the informed consent form and must be deemed by operative surgeon not to have medical contraindications for delayed-delayed approach.
• Patients must be 18 years of age or older.

You may not qualify if…

• Patients in whom it is not known preoperatively to need postmastectomy radiation therapy.
• Patients with inflammatory breast cancer.
• Patients in whom the breast skin can not be spared because of involvement with breast cancer.
• Any patient deemed by the radiation oncologist during preoperative consultation to be an inappropriate patient for this protocol.
• Patients that can not commit to receiving postmastectomy radiation treatment in addition to breast reconstructive procedures at MD Anderson Cancer Center or satellite affiliates.

Where it is running

• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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