Metastatic Breast Cancer Clinical Trial
Official title:
An Open Label, Non Randomized, Multicenter Phase 1/2b Study Investigating Safety and Efficacy of PQR309 and Eribulin Combination in Patients With Locally Advanced or Metastatic HER2 Negative and Triple-Negative Breast Cancer
This study is an open-label,non randomized, multi-center, phase 1/2b (dose escalation followed by expansion part) study evaluating clinical safety, efficacy and pharmacokinetics of PQR309 in combination with standard dose of eribulin in patients with locally advanced or metastatic HER2-negative (escalation part) and Triple Negative Breast Cancer (expansion part).
- The primary objective of the escalation part is to assess the maximum tolerated dose
(MTD) of PQR309 combined with the standard eribulin dose in patients with HER2 negative
breast cancer following a "modified" 3 by 3 design.
- For the expansion part the objective is to evaluate efficacy of PQR309 in combination
with eribulin in patients with Triple Negative Breast Cancer
- Once the MTD of continuous daily PQR309 dosing has been established, intermittent
schedules of PQR309 ("2 days on/ 5 days off" or "Monday / Thursday") will be evaluated.
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