Endoscopic Breast Surgery in Treating Patients With Breast Cancer

Endoscopic Breast Surgery Feasibility Study

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01222377

Enrollment

Registered

2010-10-18

Start date

2010-09-30

Completion date

2011-10-31

Last updated

2014-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

PROCEDUREendoscopic surgery

Undergo endoscopic breast surgery

PROCEDUREquality-of-life assessment

Ancillary studies

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

15 Years to No maximum

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

Design outcomes

Primary

Measure	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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026