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Pilot Study: High Risk Breast Cancer Screening Pilot Study


N/A
25 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Pilot Study: High Risk Breast Cancer Screening Pilot Study


OBJECTIVES:

- 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.

- 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.

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 200 patients will be accrued for this study within 2 years.

Inclusion 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

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

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- Not specified

Endocrine therapy

- Not specified

Radiotherapy

- Not specified

Surgery

- Not specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Screening

Principal Investigator

Mitchell Schnall, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Abramson Cancer Center of the University of Pennsylvania

Authority:

United States: Federal Government

Study ID:

CDR0000066851

NCT ID:

NCT00003736

Start Date:

June 1999

Completion Date:

Related Keywords:

  • Breast Cancer
  • breast cancer
  • Breast Neoplasms

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
University of Colorado Cancer CenterDenver, Colorado  80262
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
University of Pennsylvania Cancer CenterPhiladelphia, Pennsylvania  19104
Simmons Cancer Center - DallasDallas, Texas  75235-9154
University of Washington Medical CenterSeattle, Washington  98195-6043
UCSF Cancer Center and Cancer Research InstituteSan Francisco, California  94115-0128
Porter Adventist HospitalDenver, Colorado  80210
Cancer Center at the University of VirginiaCharlottesville, Virginia  22908
Lombardi Cancer CenterWashington, District of Columbia  20007
Hartford HospitalHartford, Connecticut  06102-5037