Endoscopic Breast Surgery in Treating Patients With Breast Cancer

Stage IV Breast Cancer Clinical Trial

Official title:

Endoscopic Breast Surgery Feasibility Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01222377
• Other study ID #: 1B-09-14
• Secondary ID: NCI-2010-02088
• Status: Terminated
• Phase: N/A
• First received: October 14, 2010
• Last updated: February 5, 2014
• Start date: September 2010
• Est. completion date: October 2011

Study information

• Verified date: February 2014
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Breast Neoplasms, Male
• Male Breast Cancer
• Recurrent Breast Cancer
• Stage IA Breast Cancer
• Stage IB Breast Cancer
• Stage II Breast Cancer
• Stage IIIA Breast Cancer
• Stage IIIB Breast Cancer
• Stage IIIC Breast Cancer
• Stage IV Breast Cancer

Intervention

Procedure:
• endoscopic surgery
Undergo endoscopic breast surgery
• quality-of-life assessment
Ancillary studies

Locations

Country	Name	City	State
United States	USC/Norris Comprehensive Cancer Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To estimate the surgical complication rate among all patients having EBS and the local recurrence rate among patients with breast cancer		5 years	No
Secondary	To evaluate the safety, breast cosmesis and patient quality of life following EBS		After completion of study treatment	Yes