Breast Reconstruction Following Breast Cancer in Very High Risk Patients

Withdrawn before enrolling · Not applicable

Conditions studied: Breast Cancer, Malignant Neoplasm of Breast

In brief

The purpose of this study is to: 1. Evaluate whether immediate or delayed reconstruction should be offered for breast reconstruction candidates with higher risk for surgical complications by comparing complications, quality of life, and hospital costs 2. Determine the efficacy of risk reduction strategies for breast reconstruction patients with higher risk for surgical complications

Key facts

Study ID

NCT03261323

Run by

Case Comprehensive Cancer Center

People needed

0

Starts

2019-05-31

Expected to finish

2022-07-01

Last updated by the study team

2022-05-20

Who can join

Age: 19 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must have histologically or cytologically confirmed breast cancer or indication for prophylactic mastectomy.
• Subjects must be breast reconstruction candidates using implant based breast reconstruction.
• Subjects must have a pre-operative risk >20% complication prediction from the Breast Reconstruction Risk Assessment (BRA) Score for implant-based breast reconstruction candidates
• Subjects must have the ability to understand and the willingness to sign a written informed consent document.

You may not qualify if…

• Prior breast cancer surgical treatment
• Prior breast reconstruction
• Inability to provide written consent

Where it is running

• Cleveland Clinic, Case Comprehensive Cancer Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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