I-SPY Phase I/Ib (I-SPY-P1) is an open-label, multisite platform study designed to evaluate single agents or combinations in a metastatic treatment setting that may be relevant for breast cancer patients with the overall goal of moving promising drug regimens into the I-SPY 2 SMART Design Trial (NCT01042379) and/or other oncology-based trials in a timely manner.
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Incidence of Adverse Events related to the treatment
Timeframe: Start of treatment to 30 days post treatment (estimated 12 -18 months)
Incidence of Dose Limiting Toxicities (DLTs) at each dose level
Timeframe: DLT observation period: Start of treatment to 21 days (Cycle 1)
Maximum Tolerated Dose (MTD)
Timeframe: Start of treatment to the date of last participant at end of DLT observation period at highest dose level (estimated 6 months)
Recommended Phase 2 Dose (RP2D)
Timeframe: Start of treatment to the date of last participant at highest dose level (estimated 6 months)
Overall Response Rate (ORR)
Timeframe: Start of treatment to 12 months
Duration of Response (DOR)
Timeframe: Start of treatment to 12 months