Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Positron Emission Tomography Before Surgery in Evaluating Women With Primary or Recurrent Breast Cancer

Basic Trial Information

Objectives

1. 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.
2. Determine how often clinical management and operative intervention plans for patients are altered based on these FDG-PET scan findings.
3. Determine whether FDG-PET results in more accurate detection of disease in these patients.

Entry 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

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• See Disease Characteristics

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• See Disease Characteristics

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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Elisa Rush Port, MD, Protocol chair		Ph: 212-639-5461; 800-525-2225 Email: porte@mskcc.org

Registry Information
Official Title		A Pilot Study To Assess The Utility Of 18F-Fluorodeoxyglucose Positron Emission Tomography (PET) In The Pre-Operative Evaluation Of Patients With Primary And Recurrent Breast Carcinoma
Trial Start Date		2001-10-23
Trial Completion Date		2009-02-10
Registered in ClinicalTrials.gov		NCT00039286
Date Submitted to PDQ		2002-04-03
Information Last Verified		2008-12-14
NCI Grant/Contract Number		CA08748

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