Breast cancer clinical trials face unique challenges due to the disease’s biological complexity, heterogeneity, diverse patient population and rapidly evolving treatment landscape. The biological heterogeneity of breast cancer creates opportunities to tailor interventions across the treatment continuum, but also introduces complexity in clinical trial design, requiring nuanced eligibility criteria and stratified enrollment strategies that can slow recruitment and complicate statistical analysis.
Trials must account for multiple molecular subtypes, which can limit eligible participants and complicate study design. Recruitment is often hindered by restrictive eligibility criteria, lack of awareness and underrepresentation. Additionally, the fast pace of therapeutic innovation can render control arms outdated, requiring adaptive trial designs that are resource-intensive and statistically demanding.