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Endoscopic Breast Surgery in Treating Patients With Breast Cancer

University of Southern California logo

University of Southern California

Status

Terminated

Conditions

Stage IIIA Breast Cancer
Stage IB Breast Cancer
Male Breast Cancer
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer
Stage II Breast Cancer
Stage IA Breast Cancer
Recurrent Breast Cancer
Stage IV Breast Cancer

Treatments

Procedure: endoscopic surgery
Procedure: quality-of-life assessment

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT01222377
1B-09-14
NCI-2010-02088

Details and patient eligibility

About

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.

Full 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.

Enrollment

2 patients

Sex

All

Ages

15+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

2 participants in 1 patient group

Arm I
Experimental group
Description:
Patients undergo endoscopic breast surgery.
Treatment:
Procedure: quality-of-life assessment
Procedure: endoscopic surgery

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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