Spots Global Cancer Trial Database for AUY922 With Lapatinib and Letrozole for ER+ HER2+ Advanced Breast Cancer

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Trial Identification

Brief Title: AUY922 With Lapatinib and Letrozole for ER+ HER2+ Advanced Breast Cancer

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

Study ID: NCT01361945

Conditions

Breast Cancer

Metastatic Breast Cancer

HER-2 Positive Breast Cancer

ER Positive Breast Cancer

Interventions

AUY922

Study Description

Brief Summary: 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 +.

Detailed Description: 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)