After ALTTO: I-SPY Will Hold More Clues About pCR Surrogate Endpoint

 
• By Emily Hayes
  
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The pathological complete response surrogate marker has been hailed as the key to getting drugs to market faster with small studies, but came under attack at ASCO with the failed ALTTO breast cancer trial. Co-lead I-SPY investigator Laura Esserman takes a critical look at ALTTO and explains why the jury is still out on pCR; story features an audio clip of Esserman’s interview with “The Pink Sheet.”

The failure of the ALTTO breast cancer study of Herceptin/Tykerb cast doubt on whether the surrogate endpoint of pathological complete response can predict outcomes in breast cancer, but investigators on the I-SPY trials say their upcoming Phase III neoadjuvant trial will provide another chance to test the pCR endpoint – using a much more rigorous approach.

Pathological complete response (pCR) is an emerging surrogate marker that has promise to dramatically reduce trial size and drug development...

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