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

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ClinicalTrials.gov Identifier: NCT01271738
Recruitment Status : Completed
First Posted : January 7, 2011
Last Update Posted : August 17, 2015
Sponsor:
Information provided by (Responsible Party):
Monica Rizzo, Emory University

Brief 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).


Condition or disease Intervention/treatment 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 Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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
Study Start Date : September 2009
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Monica Rizzo, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT01271738     History of Changes
Other Study ID Numbers: IRB00013658
WCI1659-09 ( Other Identifier: Other )
First Posted: January 7, 2011    Key Record Dates
Last Update Posted: August 17, 2015
Last Verified: August 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
Neoplasms by Site
Breast Diseases
Skin Diseases