EMA: Guideline on the role of the pathological Complete Response as an endpoint in neoadjuvant breast cancer studies

Neoadjuvant chemotherapy is commonly used in locally advanced breast cancer (LABC) patients to facilitate breast conserving surgery. Currently, disease-free survival (DFS) is considered to be an appropriate endpoint for treatment effect and as a surrogate endpoint for overall survival (OS). As new therapies have emerged, the DFS and ultimately the OS of patients with breast cancer has increased, and thereby the time needed to procure confirmatory data.

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