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
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|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
- 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.
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
|United States, Georgia|
|Emory University Winship Cancer Institute|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Monica Rizzo, MD||EmoryUniversity Winship Cancer Institute|