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Evaluating and Comparing Two Surgical Methods for Treatment of Early Stage Breast Cancer

NCT01271738 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2015-08-17

No results posted yet for this study

Summary

The goal of this study is to compare two different types of breast surgery. In the first type, the doctor removes only the tumor. In the second type, the doctor removes the tumor and some of the tissue around the tumor called margins. The amount of breast tissue removed is similar. The removal of the tumor only has up to 40% chance of reoperation because the tumor is too close to the margin. The primary goal of this study is to see if the additional margins can decrease the need to return to the operating room. Both types of surgery are well accepted, and participating in the study would not give you a better chance to cure the cancer. At present, most breast surgeons remove the tumor without the additional margins. For all patients who have this operation, there is a high incidence of return to the operating room for margins re-excision: as many as 40% as patients can have a re-operation.

At present, we do not know if taking the additional margins prevents the cancer from returning in the breast or not. If the cancer comes back in your breast, this is a recurrence and your breast will have to be removed (mastectomy).

Conditions

  • Breast Neoplasms
  • Breast Cancer
  • Breast Tumors
  • Cancer of Breast
  • Cancer of the Breast
  • Human Mammary Carcinoma
  • Neoplasms, Breast

Interventions

PROCEDURE

Remove tumor only

No additional margins (tissue) removed at the initial surgery

PROCEDURE

Removal of tumor and tissue

5 additional margins (tissue) removed at the time of surgery

Sponsors & Collaborators

  • Emory University

    lead OTHER

Principal Investigators

  • Monica Rizzo, MD · EmoryUniversity Winship Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01271738 on ClinicalTrials.gov