I-SPY Graduates: Where Are They Now?

Five neoadjuvant breast cancer regimens have been tested successfully in I-SPY Phase II program, but three have not moved on to sponsor-driven pivotal testing and the I-SPY 3 master protocol has yet to be used.

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The afterlife of the first group of drug candidates to successfully “graduate” from the I-SPY 2 adaptive platform trial suggests that real-world hurdles may hamper the ability of novel trial designs to accelerate drug development.

Since its inception in 2010, the Phase II study has identified five product candidates as having a high probability of...

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