NCT01271738

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 6, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 7, 2011

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

August 17, 2015

Status Verified

August 1, 2015

Enrollment Period

5.4 years

First QC Date

December 6, 2010

Last Update Submit

August 13, 2015

Conditions

Breast NeoplasmsBreast CancerBreast TumorsCancer of BreastCancer of the BreastHuman Mammary CarcinomaNeoplasms, Breast

Keywords

Breast CancerTumors or cancer of the human breastBreast TumorsCancer of BreastCancer of the BreastHuman Mammary CarcinomaNeoplasms, Breast

Outcome Measures

Primary Outcomes (1)

  • Comparing 2 surgical methods for treatment of early stage breast cancer

    The investigator will survey patients with the cosmetic assessment survey after the surgical procedure.

    Post operative evaluation will be at 30 days, then at 4-7 months and last at 12-15 months.

Study Arms (2)

Breast Conserving Surgery (BCS)

ACTIVE COMPARATOR
Procedure: Remove tumor only

Breast Conserving Surgery with Additional 5 Margins (BCS + M)

ACTIVE COMPARATOR
Procedure: Removal of tumor and tissue

Interventions

Remove tumor onlyPROCEDURE

No additional margins (tissue) removed at the initial surgery

Breast Conserving Surgery (BCS)
Removal of tumor and tissuePROCEDURE

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

Breast Conserving Surgery with Additional 5 Margins (BCS + M)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Stage IV breast cancers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory University Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsNeoplasms

Interventions

Histocompatibility Testing

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Immunologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesImmunologic Techniques

Study Officials

  • Monica Rizzo, MD

    EmoryUniversity Winship Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 6, 2010

First Posted

January 7, 2011

Study Start

September 1, 2009

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

August 17, 2015

Record last verified: 2015-08

Locations

US(1)