Endoscopic Breast Surgery in Treating Patients With Breast Cancer

University of Southern California2 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Male Breast Cancer Recurrent Breast Cancer Stage IA Breast Cancer Stage IB Breast Cancer

Eligibility

Sex: ALLMin age: 15 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

To estimate the surgical complication rate among all patients having EBS and the local recurrence rate among patients with breast cancer

Time frame: 5 years

Secondary Outcomes

To evaluate the safety, breast cosmesis and patient quality of life following EBS

Time frame: After completion of study treatment