RATIONALE: Screening tests may help doctors detect cancer cells early and plan more effective treatment for breast cancer. Diagnostic procedures such as MRI may improve the ability to detect breast cancer. PURPOSE: Screening and diagnostic trial to study the effectiveness of MRI scans in women who are at high risk for developing breast cancer.

Condition	Treatment or Intervention
Breast Cancer	Procedure: screening  Procedure: diagnostic  Procedure: screening intervention  Drug: study of high risk factors  Drug: comparison of screening methods  Drug: breast imaging studies  Drug: motexafin gadolinium

Further Study Details: 

OBJECTIVES: I. Estimate the diagnostic yield and positive predictive value of breast magnetic resonance imaging (MRI) for the detection of cancer in women who are at greater than 25% lifetime risk for developing breast cancer. II. Compare the diagnostic yield and positive predictive value of MRI with conventional breast cancer screening (mammography and physical examination) for the detection of breast cancer in women with a greater than 25% lifetime risk of developing breast cancer.

PROTOCOL OUTLINE: All patients receive a physical exam within 90 days of initial MRI scan. Patients undergo a two view screening mammogram within 3 months prior to study entry. Patients undergo an MRI with gadolinium contrast at entry. All lesions identified as suspicious on physical examination, mammography, or MRI undergo a core needle or excisional biopsy.

PROJECTED ACCRUAL: A total of 420 patients will be accrued for this study within 2 years.

Ages Eligible for Study:  25 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Patients at greater than 25% lifetime risk for breast cancer on the basis of family history or a genetic test
• Prior breast cancer allowed if patient meets the greater than 25% lifetime risk Patients with greater than 5 years since diagnosis must have at least 50% probability for developing breast cancer by the Couch model or be positive for BRCA1 or BRCA2 mutation
• Hormone receptor status: Not specified

--Prior/Concurrent Therapy--

• Not specified

--Patient Characteristics--

• Age: 25 and over
• 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 contraindications to MRI scan including patients with pacemakers, magnetic aneurysm clips or other implanted magnetic devices, or severe claustrophobia Not pregnant

California
      UCSF Cancer Center and Cancer Research Institute, San Francisco,  California,  94143-0128,  United States
Colorado
      Porter Adventist Hospital, Denver,  Colorado,  80210,  United States
      University of Colorado Cancer Center, Denver,  Colorado,  80010,  United States
Connecticut
      Hartford Hospital, Hartford,  Connecticut,  06102-5037,  United States
District of Columbia
      Lombardi Cancer Center, Washington,  District of Columbia,  20007,  United States
New York
      Roswell Park Cancer Institute, Buffalo,  New York,  14263-0001,  United States
North Carolina
      Lineberger Comprehensive Cancer Center, UNC, Chapel Hill,  North Carolina,  27599-7295,  United States
Pennsylvania
      University of Pennsylvania Cancer Center, Philadelphia,  Pennsylvania,  19104-4283,  United States
Texas
      Simmons Cancer Center - Dallas, Dallas,  Texas,  75235-9154,  United States
Virginia
      Cancer Center at the University of Virginia, Charlottesville,  Virginia,  22908,  United States
Washington
      University of Washington Medical Center, Seattle,  Washington,  98195-6043,  United States
Canada, Ontario
      University of Toronto, Toronto,  Ontario,  M5S 1A8,  Canada

Study chairs or principal investigators

Mitchell Schnall,  Study Chair,  University of Pennsylvania Cancer Center   

Study ID Numbers:  CDR0000066851; UPCC-ACR-6884
Record last reviewed:  August 2003
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003736
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08