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One in five people with advanced cancer has brain spread, yet most trials refuse them. Requiring brain cohorts would give those patients evidence instead of guesswork.
Brain metastasis exclusion criteria persist by habit, and regulators and professional bodies have issued guidance encouraging inclusion of patients with stable treated brain metastases. Making a CNS cohort with CNS-specific response endpoints a default expectation for registrational trials in CNS-tropic cancers, unless justified otherwise, would generate labelled intracranial data rather than post-approval retrospectives.
Shares ALINA, HER2CLIMB, HER2-positive brain metastases, The brain: barrier and sanctuary.
Shares HER2CLIMB, HER2-positive brain metastases.
Shares European Society for Medical Oncology (ESMO), American Society of Clinical Oncology (ASCO), Trial design, endpoints and cost.
Shares HER2CLIMB, HER2-positive brain metastases, The brain: barrier and sanctuary.
Shares American Society of Clinical Oncology (ASCO), Trials enrol too few, too slowly.
Shares American Society of Clinical Oncology (ASCO), Trials enrol too few, too slowly.
Shares American Society of Clinical Oncology (ASCO), Trials enrol too few, too slowly.
Shares European Society for Medical Oncology (ESMO), American Society of Clinical Oncology (ASCO), Trial design, endpoints and cost.