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OpenTrials
Completed

NCT Number: NCT01271738

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

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).

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Emory University Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remove tumor only

Procedure

No additional margins (tissue) removed at the initial surgery

Removal of tumor and tissue

Procedure

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

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Jan 7, 2011
Registry last updated
Aug 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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