Stopped: The sponsor decided to terminate study after 70% of participants had experienced a progression-free survival event.
This multicenter study will assess the maximum tolerated dose (MTD) of capecitabine in combination with Kadcyla (trastuzumab emtansine) in participants with HER2-positive mBC or HER2-positive LA/mGC using a Phase 1 design, followed by a randomized, open-label Phase 2 part to explore the efficacy and safety of the combination of Kadcyla and capecitabine compared with Kadcyla alone in participants with mBC. The anticipated time on study treatment is until disease progression, intolerable toxicity, withdrawal of consent, or study end.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Phase 1 (mBC): Percentage of Participants With Dose-Limiting Toxicities (DLTs)
Timeframe: Continuously during Cycle 1 (up to 3 weeks)
Phase 1 (mBC): Maximum Tolerated Dose (MTD) of Capecitabine When Combined With Trastuzumab Emtansine (3.6 mg/kg Every 3 Weeks)
Timeframe: Continuously during Cycle 1 (up to 3 weeks)
Phase 2 (mBC): Percentage of Participants With Best Overall Response (BOR) as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Timeframe: Baseline until CR/PR, consent withdrawal, or study end whichever occurred first (up to approximately 2.5 years overall)
Phase 1 (LA/mGC): Percentage of Participants With DLTs
Timeframe: Continuously during 3 weeks
Phase 1 (LA/mGC): MTD of Capecitabine When Combined With Trastuzumab Emtansine (2.4 mg/kg QW)
Timeframe: Continuously during 3 weeks