Neoadjuvant Lenvatinib Combined With Letrozole in Hormone Receptor Positive Breast Cancer
Status:
Recruiting
Trial end date:
2021-06-01
Target enrollment:
Participant gender:
Summary
This is a single-centre study comprising two phases: a lead-in phase Ib and a phase II
randomized portion.
Lead-in Phase Ib study A lead-in phase I study will be built into this protocol to confirm
the dose of lenvatinib that can safely be combined with letrozole.
We expect that the optimal phase II dose level will be determined after recruiting 12-18
subjects into phase Ib. This dose level will be the one to be tested in the phase II portion
of the study.
Phase II open label study In this part of the study, eligible patients will be treated with
single agent lenvatinib at the phase II recommended dose for 2 weeks, followed by lenvatinib
combined with letrozole 2.5mg daily for 12 weeks.
A total of 30 patients with ER positive breast cancer and measurable primary tumor will be
enrolled over a period of 24-30 months