207_Combined course Presentations

Neoadjuvant Trials

Newly diagnosed pt Tumor in place

Post-treatment clinical and correlative data

Drug Rx

Therapeutic intent and duration

• Bad  :

• Good  :

– pCR only validated endpoint. Irrelevant in many (ER+) – Quantitative relationship pCR to DFS/OS not established • Trials underpowered for these endpoints – Macromet = micromet? – Drugs must be well known

– Small, fast – Pick-a-winner – pCR is a good surrogate endpoint (FDA registrational option) – DFS/OS can be collected in same cohort