Endoscopic Breast Surgery in Treating Patients With Breast Cancer

February 5, 2014 updated by: University of Southern California

Endoscopic Breast Surgery Feasibility Study

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • USC/Norris Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I
Patients undergo endoscopic breast surgery.
Procedure: quality-of-life assessment
Ancillary studies
Other Names:
  • quality of life assessment
Procedure: endoscopic surgery
Undergo endoscopic breast surgery
Other Names:
  • surgery, endoscopic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate the safety, breast cosmesis and patient quality of life following EBS
Time Frame: After completion of study treatment
After completion of study treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

October 14, 2010

First Submitted That Met QC Criteria

October 15, 2010

First Posted (Estimate)

October 18, 2010

Study Record Updates

Last Update Posted (Estimate)

February 6, 2014

Last Update Submitted That Met QC Criteria

February 5, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1B-09-14
  • NCI-2010-02088

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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