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Endoscopic Breast Surgery in Treating Patients With Breast Cancer

Primary Purpose

Male Breast Cancer, Recurrent Breast Cancer, Stage IA Breast Cancer

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
endoscopic surgery
quality-of-life assessment
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Male Breast Cancer

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • USC/Norris Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm I

Arm Description

Patients undergo endoscopic breast surgery.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 14, 2010
Last Updated
February 5, 2014
Sponsor
University of Southern California
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01222377
Brief Title
Endoscopic Breast Surgery in Treating Patients With Breast Cancer
Official Title
Endoscopic Breast Surgery Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Terminated
Why Stopped
P.I. left
Study Start Date
September 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southern California
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
Patients undergo endoscopic breast surgery.
Intervention Type
Procedure
Intervention Name(s)
endoscopic surgery
Other Intervention Name(s)
surgery, endoscopic
Intervention Description
Undergo endoscopic breast surgery
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Other Intervention Name(s)
quality of life assessment
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
To evaluate the safety, breast cosmesis and patient quality of life following EBS
Time Frame
After completion of study treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis Holmes
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
USC/Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Endoscopic Breast Surgery in Treating Patients With Breast Cancer

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