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

This study has been completed.
Information provided by (Responsible Party):
Monica Rizzo, Emory University Identifier:
First received: December 6, 2010
Last updated: August 13, 2015
Last verified: August 2015

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).

Condition Intervention
Breast Neoplasms
Breast Cancer
Breast Tumors
Cancer of Breast
Cancer of the Breast
Human Mammary Carcinoma
Neoplasms, Breast
Procedure: Remove tumor only
Procedure: Removal of tumor and tissue

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Monica Rizzo, Emory University:

Primary Outcome Measures:
  • Comparing 2 surgical methods for treatment of early stage breast cancer [ Time Frame: Post operative evaluation will be at 30 days, then at 4-7 months and last at 12-15 months. ]
    The investigator will survey patients with the cosmetic assessment survey after the surgical procedure.

Enrollment: 79
Study Start Date: September 2009
Study Completion Date: February 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Breast Conserving Surgery (BCS) Procedure: Remove tumor only
No additional margins (tissue) removed at the initial surgery
Active Comparator: Breast Conserving Surgery with Additional 5 Margins (BCS + M) Procedure: Removal of tumor and tissue
5 additional margins (tissue) removed at the time of surgery


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01271738

United States, Georgia
Emory University Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Principal Investigator: Monica Rizzo, MD EmoryUniversity Winship Cancer Institute
  More Information

Responsible Party: Monica Rizzo, Principal Investigator, Emory University Identifier: NCT01271738     History of Changes
Other Study ID Numbers: IRB00013658
WCI1659-09 ( Other Identifier: Other )
Study First Received: December 6, 2010
Last Updated: August 13, 2015

Keywords provided by Monica Rizzo, Emory University:
Breast Cancer
Tumors or cancer of the human breast
Breast Tumors
Cancer of Breast
Cancer of the Breast
Human Mammary Carcinoma
Neoplasms, Breast

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases processed this record on May 25, 2017