Comparison of Two Types of Biopsy in Patients With Breast Lesions

Randomized Prospective Trial Comparing Radioactive Seed Localized Breast Biopsy to Needle Localized Breast Biopsy

RATIONALE: Biopsy is the removal of cells or tissue for examination under a microscope. It is not yet known which type of breast biopsy is more effective for diagnosing breast lesions.

PURPOSE: Randomized diagnostic trial to compare the effectiveness of two different types of biopsy in patients who have breast lesions that cannot be felt upon examination.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: Low dose radioactive seed followed by surgery and mammogram; Procedure: Needle localized breast biopsy with specimen x-ray

Detailed Description

OBJECTIVES: I. Compare the effect of low dose radioactive seed localized breast biopsy versus needle localized breast biopsy on operative time and tissue loss in patients with nonpalpable breast lesions. II. Compare the cost effectiveness of these diagnostic methods in these patients. III. Demonstrate that radioactive seed localization allows for elimination of specimen x-ray in these patients. IV. Demonstrate that radioactive seeds may be placed safely for 1-7 days prior to surgical removal in these patients.

OUTLINE: This is a randomized study. Patients are randomized to one of two diagnostic arms. Arm I: Patients undergo radiographic placement of a radioactive seed (either iodine I 125 or palladium Pd 103) into the suspicious lesion. Patients then undergo surgery to remove the lesion along with the seed and a small margin of surrounding breast tissue followed 3 months later by a postoperative mammogram. Arm II: Patients undergo a needle localized breast biopsy with a specimen x-ray.

• Study Type: Interventional
• Enrollment (Actual): 117
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612-9497
      • H. Lee Moffitt Cancer Center and Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

DISEASE CHARACTERISTICS: Suspicious nonpalpable breast lesion requiring breast biopsy for diagnosis OR Nonpalpable breast lesion that is not amenable to core needle biopsy or advanced breast biopsy instrumentation (ABBI) excision Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: 18 and over Menopausal status: Not specified Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant

PRIOR CONCURRENT THERAPY: Not specified

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: I: Radioactive Seed Localized Breast Biopsy; Arm I: Patients undergo radiographic placement of a radioactive seed (either iodine I 125 or palladium Pd 103) into the suspicious lesion. Patients then undergo surgery to remove the lesion along with the seed and a small margin of surrounding breast tissue followed 3 months later by a postoperative mammogram.	Procedure: Low dose radioactive seed followed by surgery and mammogram; either iodine I 125 or palladium Pd 103
Active Comparator: Arm II: Needle Localized Breast Biopsy; Arm II: Patients undergo a needle localized breast biopsy with a specimen x-ray.	Procedure: Needle localized breast biopsy with specimen x-ray

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tissue Loss Rates for Each Arm	Compare the effect of low dose radioactive seed localized breast biopsy versus needle localized breast biopsy on tissue loss in patients with nonpalpable breast lesions.	18 months
Operative Time Rates in Each Group	Compare the effect of low dose radioactive seed localized breast biopsy versus needle localized breast biopsy on operative time in patients with nonpalpable breast lesions.	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Adverse Events for Each Group	Review of adverse events utilizing Common Toxicity Criteria (CTC) V3.	18 months

Collaborators and Investigators

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Charles E. Cox, MD, FACS, H. Lee Moffitt Cancer Center and Research Institute

Study record dates

Study Major Dates

• Study Start: November 1, 1999
• Primary Completion (Actual): July 1, 2001
• Study Completion (Actual): July 1, 2006

Study Registration Dates

• First Submitted: July 5, 2000
• First Submitted That Met QC Criteria: April 1, 2004
• First Posted (Estimate): April 2, 2004

Study Record Updates

• Last Update Posted (Estimate): September 26, 2012
• Last Update Submitted That Met QC Criteria: September 24, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: biopsy; radioactive seed; nonpalpable lesions
• Other Study ID Numbers: MCC-12114; NCI-G00-1808 (Other Identifier: NCI)