Endoscopic Breast Surgery in Treating Patients With Breast Cancer

Not Applicable

Terminated

• Conditions: Male Breast Cancer; Recurrent Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IA Breast Cancer; Stage IB Breast Cancer; Stage II Breast Cancer; Stage IIIC Breast Cancer; Stage IV Breast Cancer
• Interventions: Procedure: endoscopic surgery; Procedure: quality-of-life assessment

• Registration Number: NCT01222377
• Lead Sponsor: University of Southern California

Brief Summary

RATIONALE: Endoscopic breast surgery (EBS) is a less invasive type of surgery for breast cancer and may have fewer side effects and improve recovery. PURPOSE: This clinical trial studies endoscopic breast surgery in treating patients with breast cancer.

Detailed Description

PRIMARY OBJECTIVES: I. To determine the surgical complication rate in patients undergoing EBS for benign or malignant disease and the 5-year local recurrence rate following endoscopic breast surgery among subjects undergoing EBS for breast cancer at USC. SECONDARY OBJECTIVES: I. To evaluate the safety, breast cosmesis and patient quality of life following EBS. OUTLINE: Patients undergo endoscopic breast surgery. After completion of study treatment, patients are followed up every 6 months for 5 years.

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-10-14
• Study First Submitted QC: 2010-10-15
• Study First Posted: 2010-10-18
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-05
• Last Update Posted: 2014-02-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

• Breast cancer or prophylactic mastectomy requiring axillary nodal staging
• Breast disease (e.g., fibroadenoma, ADH)
• Ability to read and/or comprehend consent form and questionnaires
• Ability to follow-up per protocol
• Not pregnant or breastfeeding

Exclusion Criteria

• Pregnant or breastfeeding
• Evidence of chest wall or skin* involvement
• NOTE: *may be endoscopy-assisted

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm I	quality-of-life assessment	Patients undergo endoscopic breast surgery.
Arm I	endoscopic surgery	Patients undergo endoscopic breast surgery.

Primary Outcome Measures

Name	Time	Method
To estimate the surgical complication rate among all patients having EBS and the local recurrence rate among patients with breast cancer	5 years

Secondary Outcome Measures

Name	Time	Method
To evaluate the safety, breast cosmesis and patient quality of life following EBS	After completion of study treatment

Trial Locations

Locations (1)

USC/Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States