Endoscopic Breast Surgery in Treating Patients With Breast Cancer

University of Southern California

Status: Terminated

Conditions: Stage IIIA Breast Cancer; Stage IB Breast Cancer; Male Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer; Stage II Breast Cancer; Stage IA Breast Cancer; Recurrent Breast Cancer; Stage IV Breast Cancer

Treatments: Procedure: endoscopic surgery; Procedure: quality-of-life assessment

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01222377

1B-09-14

NCI-2010-02088

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2 patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

Arm I

Experimental group

Description:

Patients undergo endoscopic breast surgery.

Treatment:

Procedure: quality-of-life assessment

Procedure: endoscopic surgery