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Genetics of Breast and Ovarian Cancer (PDQ®): Genetics - Health Professional Information [NCI] - Introduction

Table 1. Characteristics of the Gail and Claus Modelsa

Gail Model (Breast Cancer Risk Assessment Tool)bClaus Model
FDR = First-degree relative; SDR = second-degree relative.
a Adapted from Domchek et al.,[87]Rubenstein et al.,[88]and Rhodes.[89]
b Modified based on periodic updates.[90,91]
Data derived fromBreast Cancer Detection Demonstration Project StudyCancer and Steroid Hormone Study
Study population2,852 cases, aged ≥35 y4,730 cases, aged 20–54 y
In situ and invasive cancerInvasive cancer
3,146 controls4,688 controls
CaucasianCaucasian
Annual breast screeningNot routinely screened
Family history characteristicsFDRs with breast cancerFDRs or SDRs with breast cancer
Age of onset in relatives
Other characteristicsCurrent ageCurrent age
Age at menarche
Age at first live birth
Number of breast biopsies
Atypical hyperplasia in breast biopsy
Race (included in the most current version of the Gail model)
StrengthsIncorporates:Incorporates:
Risk factors other than family historyPaternal and maternal history
Age at onset of breast cancer
Family history of ovarian cancer
LimitationsUnderestimates risk in hereditary familiesMay underestimate risk in hereditary families
Number of breast biopsies without atypical hyperplasia may cause inflated risk estimatesMay not be applicable to all combinations of affected relatives
Does not include risk factors other than family history
Does not incorporate: 
Paternal family history of breast cancer or any family history of ovarian cancer
Age at onset of breast cancer in relatives
All known risk factors for breast cancer[89]
Best applicationFor individuals with no family history of breast cancer or one FDR with breast cancer, aged ≥50 yFor individuals with no more than two FDRs or SDRs with breast cancer
For determining eligibility for chemoprevention studies

The Gail and the Claus models will significantly underestimate breast cancer risk in women from families with hereditary breast cancer susceptibility syndromes. Generally, the Claus or the Gail models should not be the sole model used for families with one or more of the following characteristics:

  • Three individuals with breast or ovarian cancer (especially when one or more breast cancers are diagnosed before age 50 years).
  • A woman who has both breast and ovarian cancer.
  • Ashkenazi Jewish ancestry with at least one case of breast or ovarian cancer (as these families are more likely to have a hereditary cancer susceptibility syndrome).

The Gail model is the basis for the Breast Cancer Risk Assessment Tool, a computer program that is available from the National Cancer Institute by calling the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237 or TTY at 1-800-332-8615). This version of the Gail model estimates only the risk of invasive breast cancer. The Gail model has been found to be reasonably accurate at predicting breast cancer risk in large groups of white women who undergo annual screening mammography; however, reliability varies based on the cohort studied.[91,92,93,94,95,96] Risk can be overestimated in:

  • Women who do not adhere to screening recommendations.[92,93]
  • Women in the highest risk strata.[95]
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WebMD Public Information from the National Cancer Institute

Last Updated: February 25, 2014
This information is not intended to replace the advice of a doctor. Healthwise disclaims any liability for the decisions you make based on this information.
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