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Adherence to Intensive Surveillance for Hereditary Breast Cancer

25 Years
Not Enrolling
Breast Cancer

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Trial Information

Adherence to Intensive Surveillance for Hereditary Breast Cancer

Women at risk for hereditary breast cancer are recommended to undergo intensive surveillance
to maximize the likelihood of detecting the disease at an early, more curable, stage (Burke
et al. 1997, Eisenger et al. 1998, Moller et al. 1999). Although the particular
recommendations of different groups have varied, all suggest programs that incorporate
clinical and radiographic screening performed more frequently than in the general
population, beginning at a considerably younger age. Recent studies demonstrating the
sensitivity of breast MRI have led several groups to incorporate this technology as an
incremental (not replacement) modality, further increasing the intensity of the surveillance
regimen. While data are beginning to accumulate regarding the effectiveness of aggressive
surveillance, little is known about the ability and willingness of women to adhere to these
rigorous schedules, nor about the psychosocial and economic costs of the programs. Based
upon the Cognitive-Social Health Information Processing (C-SHIP)model (Miller, Shoda, Hurley
1996), we hypothesize that the ability to adhere to a proposed screening regimen will result
from a complex and dynamic interaction between the nature of that regimen, events that can
be expected to occur in the course of screening (such as abnormal results and practical
barriers) and key psychological factors such as the individual's attentional style,
affective state, perceived risk of cancer, cancer-specific worries, and beliefs regarding
the effectiveness of screening. To test the hypothesis, we propose to prospectively study
women with a hereditary risk for breast cancer participating in a structured surveillance
program of monthly breast self-examination, semi-annual clinical examination and annual
mammography, augmented by annual interval breast MRI.

Inclusion Criteria:

- Female

- Age 25 years or greater

- Genetic predisposition as defined by one of the following:

- Known BRCA1 or BRCA2 mutation (deleterious or uncertain significance) OR

- Untested first-degree relative of an individual with a known deleterious BRCA
mutation OR

- Unaffected first-degree relative of an affected individual within a hereditary
breast-ovarian kindred in which no testing has been performed or testing is
negative, defined as: 3 or more women in 2 generations affected with breast or
ovarian cancer. Women with bilateral breast cancer and woman with both breast
and ovarian cancer count as single individual AND 1 woman must be first-degree
relative of the other two, or related to the other two through a male AND At
least 1 woman affected with breast cancer before age 50 or ovarian cancer at any

- Able to understand and complete English-language questionnaires

- Intend to receive clinical and radiographic follow-up at MSKCC

- Women will not be excluded if they have previously received clinical and
radiographic follow-up at either MSKCC or another institution.

Exclusion Criteria:

- Prior history of breast or ovarian cancer

- Contraindication to breast MRI examination (e.g. aneurysm clips, pacemaker, cochlear
implant, severe claustrophobia, weight over 300 pounds) or to paramagnetic contrast
(prior IgE-type allergic reaction, sickle cell anemia, renal failure)

- Pregnant or planning to begin attempts at conception within 1 year of enrollment. A
negative serum β-hCG will not be required for study entry, nor for radiographic
examination, as this test is not routinely performed before clinically indicated
radiographic study.

- Unable for physical, psychological, or financial reasons to receive clinical and
radiographic follow-up at MSKCC

- Concurrent medical or psychological conditions that, in the opinion of the attending
physician or Principal Investigator, would place the subject at risk were she to

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

cognitive-affective mediating units that are likely to be involved in health information processing and the execution of health-protective behavior

Outcome Time Frame:

5 years 7 months

Safety Issue:


Principal Investigator

Mark Robson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

May 2003

Completion Date:

March 2009

Related Keywords:

  • Breast Cancer
  • breast cancer
  • germline mutation
  • BRCA1
  • BRCA2
  • family history
  • genetic testing
  • unaffected women over age 25 who are at elevated risk for
  • breast cancer by virtue by a hereditary predisposition
  • Breast Neoplasms



Memorial Sloan-Kettering Cancer Center New York, New York  10021