NCT01361945

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

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

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Texas Tech University Health Sciences Center, El Paso · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Breast Cancer
• Metastatic Breast Cancer
• HER-2 Positive Breast Cancer
• ER Positive Breast Cancer

Interventions

Type	Name	Description
DRUG	AUY922	AUY 922 is given intravenously weekly; letrozole and lapatinib are given orally

Timeline

• Start date: 2011-07-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2011-05-27
• Last updated: 2017-05-09