Breast Reconstruction Following Breast Cancer in Very High Risk Patients

Case Comprehensive Cancer Center

Overview

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

Primary Endpoint(s) 1. Define the optimal timing of reconstruction in patients at a higher risk for developing breast reconstruction surgical complications through a randomized prospective cohort 2. Compare immediate and delayed reconstruction outcome metrics through retrospective review Secondary Endpoint(s) 1. Evaluate Quality of life of patients at a higher risk for developing breast reconstruction surgical complications undergoing immediate versus delayed reconstruction. 2. Compare complications and reoperations between immediate versus delayed reconstruction. 3. Compare the hospital costs between immediate versus delayed reconstruction 4. Evaluate the effectiveness of risk reduction strategies

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Conditions

Breast Cancer Malignant Neoplasm of Breast

Interventions

Immediate Breast ReconstructionPROCEDURE

Only implant based surgeries will be considered in this study. The patient will be followed for at least 1 year after the last reconstruction surgery. Reconstruction will be attempted immediately after mastectomy.

Delayed Breast ReconstructionPROCEDURE

Risk reduction strategies on smoking, weight, and chronic disease control will be offered. The individual risk will be recalculated every three months. Delayed breast reconstruction will be offered when core cancer therapies (mastectomy, chemotherapy and radiation) are complete. Only implant based surgeries will be considered in this study. The patient will be followed for at least 1 year after the last reconstruction surgery.

Breast-Q questionnaireOTHER

Eligibility

Sex: FEMALEMin age: 19 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * Prior breast cancer surgical treatment * Prior breast reconstruction * Inability to provide written consent

Locations (1)

Cleveland Clinic, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

optimal timing of reconstruction in patients at a higher risk for developing breast reconstruction surgical complications

Proportion of patients preferring delayed reconstruction.