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.

Condition	Treatment or Intervention
Breast Cancer	Drug: iodine I 125  Drug: palladium Pd 103

Further Study Details: 

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.

PROTOCOL 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.

PROJECTED ACCRUAL: A total of 100 patients (50 per arm) will be accrued for this study.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--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

--Prior/Concurrent Therapy--

• 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

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

Study chairs or principal investigators

Charles E. Cox,  Study Chair,  H. Lee Moffitt Cancer Center and Research Institute   

Study ID Numbers:  CDR0000068044; MCC-12114; NCI-G00-1808; MCC-IRB-5499
Record last reviewed:  March 2004
Last Updated:  October 13, 2004
Record first received:  July 5, 2000
ClinicalTrials.gov Identifier:  NCT00006031
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08