Eligibility criteria in clinical trials in breast cancer: a cohort study

Abstract

Background Breast cancer (BC) is the most common cancer type in women. The purpose of this study was to assess the eligibility criteria in recent clinical trials in BC, especially those that can limit the enrollment of older patients as well as those with comorbidities and poor performance status. Methods Data on clinical trials in BC were extracted from ClinicalTrials.gov. Co-primary outcomes were proportions of trials with different types of the eligibility criteria. Associations between trial characteristics and the presence of certain types of these criteria (binary variable) were determined with univariate and multivariate logistic regression. Results Our analysis included 522 trials of systemic anticancer treatments started between 2020 and 2022. Upper age limits, strict exclusion criteria pertaining to comorbidities, and those referring to inadequate performance status of the patient were used in 204 (39%), 404 (77%), and 360 (69%) trials, respectively. Overall, 493 trials (94%) had at least one of these criteria. The odds of the presence of each type of the exclusion criteria were significantly associated with investigational site location and trial phase. We also showed that the odds of the upper age limits and the exclusion criteria involving the performance status were significantly higher in the cohort of recent trials compared with cohort of 309 trials started between 2010 and 2012 (39% vs 19% and 69% vs 46%, respectively; p < 0.001 for univariate and multivariate analysis in both comparisons). The proportion of trials with strict exclusion criteria was comparable between the two cohorts (p > 0.05). Only three of recent trials (1%) enrolled solely patients aged 65 or 70 and older. Conclusions Many recent clinical trials in BC exclude large groups of patients, especially older adults, individuals with different comorbidities, and those with poor performance status. Careful modification of some of the eligibility criteria in these trials should be considered to allow investigators to assess the benefits and harms of investigational treatments in participants with characteristics typically encountered in clinical practice.

Patterns of distant metastasis and survival outcomes in de novo metastatic breast cancer according to age groups

“…Despite the high prevalence of cancer in older patients, their participation in oncology clinical trials has traditionally been inadequate. Recent data indicated that only 1% of trials have enrolled solely patients aged 65 or 70 and older ( 50 ). In general, using upper age limits in clinical trials presents challenges due to the considerable heterogeneity of aging.…”

Unveiling the Immune Microenvironment’s Role in Breast Cancer: A Glimpse into Promising Frontiers

“…BC has been successfully treated using CIs, although only 20-40% of patients see tangible advantages. Clinical trials exploring the efficacy and safety of these novel agents have yielded promising results in the management of BC [167,183]. CIs, such as pembrolizumab and atezolizumab, work by blocking key proteins that dampen the immune response, enabling immune cells to recognize and attack cancer cells more effectively [167].…”