Breast Reconstruction Following Breast Cancer in Very High Risk Patients

Breast Cancer Clinical Trial

Official title:

Evaluating Breast Reconstruction Timing and Risk Reduction Strategies in Patients at a Higher Risk for Developing Breast Reconstruction Surgical Complications: A Prospective Randomized Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03261323
• Other study ID #: CASE10116
• Status: Withdrawn
• Phase: N/A
• Start date: May 31, 2019
• Est. completion date: July 2022

Study information

• Verified date: May 2022
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Malignant Neoplasm of Breast
• Neoplasms

Intervention

Procedure:
• Immediate Breast Reconstruction
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 Reconstruction
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.

Other:
• Breast-Q questionnaire
Developed out of Memorial Sloan-Kettering Institute for Cancer Research, this questionnaire is designed to create a patient-reported outcome measure to provide quantifiable information about the impact and effectiveness of breast surgery. In this study it will be used for quality of life assessment

Locations

Country	Name	City	State
United States	Cleveland Clinic, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Aesthetic evaluation	Aesthetic evaluation using postoperative photos one year after the first surgery, and after the final reconstruction surgery	Until 1 year post breast reconstruction
Primary	optimal timing of reconstruction in patients at a higher risk for developing breast reconstruction surgical complications	Proportion of patients preferring delayed reconstruction.	Until 1 year post breast reconstruction
Secondary	Major complications	defined as the ones that required reoperation (infection, capsular contracture, hematoma, seroma, skin flap and flap necrosis, etc).	Until 1 year post breast reconstruction
Secondary	Minor complications	defined as the ones that were office treated, not requiring a reoperation	Until 1 year post breast reconstruction
Secondary	Number of revision surgeries	defined as surgeries not related to complications, indicated for symmetrization, aesthetic improvement, nipple reconstruction, or skin paddle removal	Until 1 year post breast reconstruction
Secondary	Hospital cost of the complete reconstruction treatment	Cost of reconstruction including the cost of complications	Until 1 year post breast reconstruction
Secondary	Change in patient satisfaction	Patient satisfaction using the pre-operative Breast-Q questionnaire to define the baseline compared to score on Breast-Q questionnaire during follow-up	Until 1 year post breast reconstruction