Endoscopic Breast Surgery in Treating Patients With Breas... | NCT01222377

Studies
Endoscopic Breast Surgery in Treating Patients With Breast Cancer

NCT01222377

Sponsor

University of Southern California

Status

Terminated

Last Update Posted

Feb 6, 2014Estimated

Enrollment

2Actual

Phase

Not Applicable

Conditions

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

Interventions

endoscopic surgery
quality-of-life assessment

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
NCI-2010-02088

Status Module

Record Verification Date

Feb 2014

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

P.I. left

Expanded Access Info

Start Date

Sep 2010

Primary Completion Date

Oct 2011Actual

Completion Date

Oct 2011Actual

First Submitted Date

Oct 14, 2010

First Submission Date that Met QC Criteria

Oct 15, 2010

First Posted Date

Oct 18, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 5, 2014

Last Update Posted Date

Feb 6, 2014Estimated

Name	Class
National Cancer Institute (NCI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Conditions Module

Conditions

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

Keywords

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm I	Experimental	Patients undergo endoscopic breast surgery.	Procedure: endoscopic surgery Procedure: quality-of-life assessment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
endoscopic surgery	Procedure	Undergo endoscopic breast surgery	Arm I

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To estimate the surgical complication rate among all patients having EBS and the local recurrence rate among patients with breast cancer		5 years

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dennis Holmes	University of Southern California	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
USC/Norris Comprehensive Cancer Center		Los Angeles	California	90033	United States

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D018567	Breast Neoplasms, Male
D001943	Breast Neoplasms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Term
D003949	Diagnostic Techniques, Surgical
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D019060	Minimally Invasive Surgical Procedures
D013514	Surgical Procedures, Operative