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Endoscopic Breast Surgery Feasibility Study

15 Years
Not Enrolling
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

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Trial Information

Endoscopic Breast Surgery Feasibility Study

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.

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

Type of Study:


Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

5 years

Safety Issue:


Principal Investigator

Dennis Holmes

Investigator Role:

Principal Investigator

Investigator Affiliation:

USC/Norris Comprehensive Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

September 2010

Completion Date:

October 2011

Related Keywords:

  • 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
  • Breast Neoplasms
  • Breast Neoplasms, Male



USC/Norris Comprehensive Cancer Center Los Angeles, California  90033-0800