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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Monica Rizzo, Emory University
ClinicalTrials.gov Identifier:
NCT01271738
First received: December 6, 2010
Last updated: November 6, 2012
Last verified: November 2012
History of Changes
  Purpose

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 Phase
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
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

Further study details as provided by 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. ] [ Designated as safety issue: Yes ]
    The investigator will survey patients with the cosmetic assessment survey after the surgical procedure.


Estimated Enrollment: 90
Study Start Date: September 2009
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: April 2013 (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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01271738

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

No publications provided

Responsible Party: Monica Rizzo, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT01271738     History of Changes
Other Study ID Numbers: WCI1659-09
Study First Received: December 6, 2010
Last Updated: November 6, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by 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
Carcinoma
Neoplasms by Site
 Breast Diseases
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on May 23, 2013