Breast Cancer Clinical Trial
Official title:
A Phase I/ II, Multi-center, Open-label Study, to Evaluate the Efficacy of AUY922 in Combination With Lapatinib With Letrozole in Postmenopausal Patients With Locally Advanced or Metastatic ER+ , HER2 + Breast Cancer
The purpose of this study is to find out what effects, administering infusions of AUY922 with hormonal therapy (letrozole) and oral targeted drug (lapatinib) will have on the patients with advanced breast cancer known as ER+ HER2 +.
The dose and schedule of AUY922 is the MTD dose identified in the phase I, given as 1 hour
infusion weekly.
The Phase II component will have a 2 stage design single arm design. (Section 9.0). Overall
response rate (ORR) is the primary endpoint. Estimated N=40 (12 in first stage) .A total of
39 response-evaluable participants is required. In the first stage, 12 response-evaluable
participants will be accrued; if there are 3 or fewer CR+PRs, the study will stop for
futility. There is a 55% probability of stopping early if, in fact, the ORR is 28%. If there
are 4 or more CR+PRs, the study will proceed to the second stage and an additional 27
response-evaluable participants will be accrued. We will accrue 1 additional patient (then
the needed 39 to account for attrition)
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