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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01271738

Enrollment

Registered

2011-01-07

Start date

2009-09-30

Completion date

2015-02-28

Last updated

2015-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Breast Cancer, Tumors or cancer of the human breast, Breast Tumors, Cancer of Breast, Cancer of the Breast, Human Mammary Carcinoma, Neoplasms, Breast

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).

Interventions

PROCEDURERemove tumor only

No additional margins (tissue) removed at the initial surgery

PROCEDURERemoval of tumor and tissue

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Comparing 2 surgical methods for treatment of early stage breast cancer	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026