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

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Emory University

Status

Completed

Conditions

Neoplasms, Breast
Cancer of Breast
Breast Tumors
Breast Cancer
Cancer of the Breast
Breast Neoplasms
Human Mammary Carcinoma

Treatments

Procedure: Removal of tumor and tissue
Procedure: Remove tumor only

Study type

Interventional

Funder types

Other

Identifiers

NCT01271738
IRB00013658
WCI1659-09 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment

79 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

79 participants in 2 patient groups

Breast Conserving Surgery (BCS)
Active Comparator group
Treatment:
Procedure: Remove tumor only
Breast Conserving Surgery with Additional 5 Margins (BCS + M)
Active Comparator group
Treatment:
Procedure: Removal of tumor and tissue

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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