RATIONALE: Imaging procedures such as positron emission tomography (PET) may improve the ability to detect the extent of breast cancer.

PURPOSE: Diagnostic trial to study the effectiveness of PET to detect the extent of breast cancer in women who have primary or recurrent breast cancer.

Condition	Treatment or Intervention
stage II breast cancer stage IIIA breast cancer recurrent breast cancer	Drug: fludeoxyglucose F 18  Procedure: diagnostic test  Procedure: radionuclide imaging  Procedure: tomography, emission computed

Further Study Details: 

OBJECTIVES:

• Determine the sensitivity, specificity, and accuracy of fludeoxyglucose F 18 (FDG) positron emission tomography (PET) as compared to conventional imaging in determining the extent of disease in women with primary or recurrent breast cancer.
• Determine how often clinical management and operative intervention plans for patients are altered based on these FDG-PET scan findings.
• Determine whether FDG-PET results in more accurate detection of disease in these patients.

OUTLINE: Patients receive fludeoxyglucose F 18 IV. Approximately 1 hour later, patients undergo positron emission tomography imaging. Some patients may undergo a repeat scan in 4-6 months.

PROJECTED ACCRUAL: A total of 100 patients (50 with primary disease and 50 with recurrent disease) will be accrued for this study within 1-2 years.

Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of breast cancer for which surgical intervention is planned
• Large primary breast cancer (i.e., larger than 5 cm, T3) as determined by prior biopsy, physical exam, or mammogram OR
• Locally advanced breast cancer (T4) OR
• Clinical suspicion of axillary nodal disease (N1-2) (i.e., stage IIB-IIIA) OR
• Locally or regionally recurrent disease
• No locally recurrent disease that is non-invasive (i.e., ductal carcinoma in situ)
• No locally advanced disease (e.g., inflammatory breast cancer) that will be treated with neoadjuvant chemotherapy without surgery
• Hormone receptor status:
• Not specified

PATIENT CHARACTERISTICS: Age:

• Not specified

Sex:

• Female

Menopausal status:

• Not specified

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

Other:

• No other malignancy except previously treated nonmelanoma skin cancer or carcinoma in situ of the cervix
• No known active infection
• No autoimmune disease or inflammatory disease (e.g., sarcoidosis or rheumatoid arthritis)
• Able to fast for 6 hours and tolerate a FDG-PET scan for the duration of the test
• Not pregnant or nursing

PRIOR CONCURRENT THERAPY: Biologic therapy:

• Not specified

Chemotherapy:

• See Disease Characteristics

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• See Disease Characteristics

New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States; Recruiting

Study chairs or principal investigators

Elisa Rush Port, MD,  Study Chair,  Memorial Sloan-Kettering Cancer Center   

Study ID Numbers:  CDR0000069369; MSKCC-01134; NCI-G02-2074; NCT00039286
Record last reviewed:  May 2004
Last Updated:  December 3, 2004
Record first received:  June 6, 2002
ClinicalTrials.gov Identifier:  NCT00039286
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08