BOLERO-3: Pretreated HER2+ Locally Advanced or Metastatic Breast Cancer in Combination with Trastuzumab and Vinorelbine
BOLERO-3 (Breast cancer trials of OraLEveROlimus) is a phase III, randomized, double-blind study of everolimus plus trastuzumab and vinorelbine in women with HER2+ locally advanced or metastatic breast cancer previously treated with a taxane and resistant to trastuzumab.
Participants are randomized to receive either everolimus (RAD001) 5 mg/day orally or placebo, plus weekly vinorelbine 25 mg/m2 IV and weekly trastuzumab 2mg/kg IV following loading dose of 4mg/kg. The BOLERO-3 clinical study will enroll 572 patients globally, in a 1:1 randomization to everolimus or placebo, at more than 160 sites.
BOLERO-3 Key facts
Primary endpoint: Progression-free survival
Secondary endpoints:
Overall survival
Objective response rate
Time to deterioration of Eastern Cooperative Oncology Group performance status
Changes in quality-of-life scores over time
Clinical benefit rate
Duration of response
Time to response
Safety
Pharmacokinetics
Target enrollment: 572
*Treatment until disease progression, unacceptable toxicity, or discontinuation for any other reason.
Click here to learn more about this clinical trial and participating centers from ClinicalTrials.gov.
Disclaimer : These are investigational studies; there is no guarantee that everolimus will become commercially available for these indications
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