Eligibility criteria in randomized phase II and III adjuvant and neoadjuvant breast cancer trials: not a significant barrier to accrual.

Posted: Jan 17, 2013
Clin Trials. 9. 5. 652-9.
KEYWORDS: International, Eligibility, Women, Cancer, Treatment, Phase 0,1,2, Phase 3-4


No single inclusion or exclusion criterion stands out as a common cause of patient ineligibility once patients are considered “potentially" eligible.

Why this item may be useful

The results of this chart review study challenge the widely-accepted theory that strict, often poorly justified eligibility criteria are a major cause of low accrual to cancer clinical trials. At a specialized breast cancer center in Canada, eligibility criteria for nine randomized breast cancer trials were grouped into five overarching categories with 37 subcategories to compare their impact on individual patients’ eligibility across studies. After excluding chart review-related, pre-screening errors and other logistical artifacts, for individual trials, few subcategories had over 10 percent of subjects who did not meet the criteria.  The authors concluded that eligibility criteria should reflect as much as possible the whole population to whom the treatment will be offered.


  • Patients included in the chart review were prescreened to be considered potentially eligible.
  • Potentially eligible patients were those who were diagnosed with invasive, nonmetastatic breast cancer during the time period each trial was recruiting and met the study’s specification for age, TNM stage, hormonal receptors, HER2 status for HER2 positive status, menopausal status, and diagnosis date.
  • The five categories of criteria were:
  •        Definition of disease
  •        [Scientific] Precision
  •        Safety
  •        Ethical and legal
  •        Administrative (logistical)
  • The criteria that had the highest impact were in the subcategories of pathology (9.1 percent for "no contralateral breast cancers" and 18.2 percent for "no  multifocal tumors"), and “other medical conditions" (11.8 percent).