Patient population N Design Treatment arms Stratification factors Endpoints Results BOLERO-1 HER2+ ABC. First line 719 Randomization 2:1 Everolimus or placebo 10 mg/day + paclitaxel 80 mg/m2 days 1, 8, 15 + trastuzumab…
Fig. 1.1 Chemical structure of rapamycin and rapalogs. Rapalogs have the indicated O-substitutions at the C-40 position of rapamycin (red circle) Temsirolimus, formerly known as CCI-779; Torcel®, Wyeth Pharmaceuticals, now…
1. Serum LDH > 1.5 times the upper limit of normal 2. Hemoglobin level < lowest limit of normal 3. Corrected serum calcium level > 10 mg/dL (2.5 mmol/L) 4. Interval of less than 1 year…
