NCT01222377

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2010

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 14, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 18, 2010

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

February 6, 2014

Status Verified

February 1, 2014

Enrollment Period

1.1 years

First QC Date

October 14, 2010

Last Update Submit

February 5, 2014

Conditions

Male Breast CancerRecurrent Breast CancerStage IA Breast CancerStage IB Breast CancerStage II Breast CancerStage IIIA Breast CancerStage IIIB Breast CancerStage IIIC Breast CancerStage IV Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

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

    After completion of study treatment

Study Arms (1)

Arm I

EXPERIMENTAL

Patients undergo endoscopic breast surgery.

Procedure: endoscopic surgeryProcedure: quality-of-life assessment

Interventions

endoscopic surgeryPROCEDURE

Undergo endoscopic breast surgery

Also known as: surgery, endoscopic
Arm I
quality-of-life assessmentPROCEDURE

Ancillary studies

Also known as: quality of life assessment
Arm I

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnant or breastfeeding
  • Evidence of chest wall or skin\* involvement
  • NOTE: \*may be endoscopy-assisted

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Breast Neoplasms, MaleBreast Neoplasms

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Dennis Holmes

    University of Southern California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2010

First Posted

October 18, 2010

Study Start

September 1, 2010

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

February 6, 2014

Record last verified: 2014-02

Locations

US(1)