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Measuring the Effect of Additional Tumor Cavity Margins Excision at the Time of Breast Conserving Surgery for Stage 0, I, II, and III Breast Cancer Patients on Re-excision Rate, Cosmetic Results and Total Costs


Phase 3
18 Years
N/A
Open (Enrolling)
Female
Breast Neoplasms, Breast Cancer, Breast Tumors, Cancer of Breast, Cancer of the Breast, Human Mammary Carcinoma, Neoplasms, Breast

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Trial Information

Measuring the Effect of Additional Tumor Cavity Margins Excision at the Time of Breast Conserving Surgery for Stage 0, I, II, and III Breast Cancer Patients on Re-excision Rate, Cosmetic Results and Total Costs


Inclusion Criteria:



- Female Patients with the diagnosis of Stage 0, I, II and III breast cancer
diagnosed/treated at the AVON Foundation Comprehensive Breast Center (AFCBC) of Grady
Memorial Hospital

- Age: no limit

Exclusion Criteria:

- Stage IV breast cancers

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Comparing 2 surgical methods for treatment of early stage breast cancer

Outcome Description:

The investigator will survey patients with the cosmetic assessment survey after the surgical procedure.

Outcome Time Frame:

Post operative evaluation will be at 30 days, then at 4-7 months and last at 12-15 months.

Safety Issue:

Yes

Principal Investigator

Monica Rizzo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

EmoryUniversity Winship Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

WCI1659-09

NCT ID:

NCT01271738

Start Date:

September 2009

Completion Date:

March 2014

Related Keywords:

  • Breast Neoplasms
  • Breast Cancer
  • Breast Tumors
  • Cancer of Breast
  • Cancer of the Breast
  • Human Mammary Carcinoma
  • Neoplasms, Breast
  • Breast Cancer
  • Tumors or cancer of the human breast
  • Breast Tumors
  • Cancer of Breast
  • Cancer of the Breast
  • Human Mammary Carcinoma
  • Neoplasms, Breast
  • Breast Neoplasms
  • Neoplasms
  • Carcinoma

Name

Location

Emory University Winship Cancer InstituteAtlanta, Georgia  30322