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Randomized, Placebo Controlled, Double Blind Phase 1b/2 Study of U3-1287 (AMG 888) in Combination With Trastuzumab Plus Paclitaxel in Newly Diagnosed HER2 Positive Metastatic Breast Cancer (MBC)
This is a Phase 1b/2 study. In Phase 1b portion, subjects will know the treatment they are receiving . Subjects will receive U3-1287 with trastuzumab plus paclitaxel . The phase 1b portion will determine if adding U3-1287 to trastuzumab plus paclitaxel will be safe in subjects with metastatic breast cancer. In phase 2 portion, subjects will be blinded to the treatments they are receiving . Subjects will receive either trastuzumab plus paclitaxel with U3-1287 or trastuzumab plus paclitaxel and placebo.The phase 2 portion will determine if adding U3-1287 to trastuzumab plus paclitaxel will be safe and improve survival in subjects with metastatic breast cancer.
Details
| Lead sponsor | Daiichi Sankyo |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | TERMINATED |
| Enrolment | 29 |
| Start date | 2011-11 |
| Completion | 2015-01-28 |
Conditions
- Metastatic Breast Cancer
Interventions
- U3-1287
- Trastuzumab
- Paclitaxel
- U3-1287
- Trastuzumab
- Paclitaxel
- Placebo
Primary outcomes
- Determination of the maximum tolerated dose based on the incidence of dose limiting toxicities (phase 1b only) — Study start to approximately 16 weeks
The following criteria will also be considered a dose limiting toxicity (DLT). * \> 15% decrease in left ventricular ejection fraction (LVEF) from baseline or an LVEF value \> 10% below lower limit of normal (LLN) * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3 x the upper limit of normal (ULN) AND total bilirubin \> 2 x ULN or international normalized ratio (INR) \> 1.5 - Progression Free Survival (Phase 2 only) — 52 weeks (Start to end of Phase 2)
Tumor assessment will be conducted every 6 weeks independent of treatment cycle in accordance with Response Evaluation Criteria in Solid Tumors (RECIST version 1.1)
Countries
Argentina, Chile