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AUY922 With Lapatinib and Letrozole for ER+ HER2+ Advanced Breast Cancer | Clinical Trials | Clareo Health

WITHDRAWNPHASE1/PHASE2

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

NCT01361945•Texas Tech University Health Sciences Center, El Paso

View on ClinicalTrials.gov

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)

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Age 18 years
•Able to sign Informed Consent
•Patients must have the following laboratory values:
•Absolute Neutrophil Count (ANC) 1.5x109/L Hemoglobin (Hgb) 9 g/dl Platelets (plt) 100x109/L
•Potassium within normal limits
•Total calcium (corrected for serum albumin) and Phosphorus within normal limits
•Magnesium above LLN or correctable with supplements
•AST/SGOT and ALT/SGPT ≤ 1.5 x Upper Limit of Normal (ULN) if AP \> 2.5 ULN
•AST/SGOT and ALT/SGPT ≤ 2.5 x Upper Limit of Normal (ULN) if AP ≤ 5.0 x ULN if
•Serum bilirubin 1.5 x ULN
+9 more criteria

Exclusion Criteria

•Unresolved diarrhea ≥ CTCAE (v4.02) grade 1
•Pregnant or lactating women
•Impaired cardiac function, including any one of the following:
•History (or family history) of long QT syndrome
•Mean QTc ≥ 450 msec on baseline ECG
•History of clinically manifested ischemic heart disease ≤ 6 months prior to study start or History of heart failure or left ventricular (LV) dysfunction (LVEF ≤ 45%) by MUGA or ECHO or arrythmia
•Patients known to be HIV positive. Testing is not required in the absence of clinical signs and symptoms suggesting HIV infection.
•Known hypersensitivity to any of the study drugs or their excipients
•Participation in another clinical study within 30 days before first study treatment

Key Dates

Start Date

July 1, 2011

Primary Completion Date

August 1, 2012

Completion Date

August 1, 2012

Last Updated

May 9, 2017

Conditions

Breast CancerMetastatic Breast CancerHER-2 Positive Breast CancerER Positive Breast Cancer

Interventions

AUY922

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RECRUITINGPHASE1

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Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 9, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

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