CLINICAL TRIAL SUMMARY

MDACC Study No:2010-0842 (clinicaltrials.gov NCT No: NCT01434303)
Title:Phase I and Phase I Trastuzumab Cohort Study of Entinostat, Lapatinib and
Trastuzumab in Patients with HER2-Positive Metastatic Breast Cancer in
Whom Trastuzumab Has Failed
Principal Investigator:Naoto Ueno
Treatment Agent:Entinostat; Lapatinib; Trastuzumab
Study Status:Open
Study Description:This goal of this clinical research study is to find the highest tolerable dose
of entinostat and lapatinib that can be given in combination to patients with
advanced or metastatic breast cancer. The effectiveness and safety of this
dose combination will be studied. Researchers will also study the safety of
the other dose combinations.

Entinostat in an investigational drug and is not FDA approved or commercially
available. It is currently being used for research purposes only. Lapatinib is
approved by the FDA for certain kinds of breast cancer. The combination of
these drugs is investigational.

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Disease Group:Breast
Phase of Study:Phase I
Treatment Agents:Entinostat
Lapatinib
Trastuzumab
Treatment Location:Only at MDACC
Estimated Length of Stay in Houston:
Supported By:NCI will supply Lapatinib and Entinostat and provide IND. Glaxosmithkline will provide financial support for correlative studies.
Return Visit:
Home Care:


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Physician Name:Naoto Ueno
Dept:Breast Medical Oncology
For Clinical Trial Enrollment:713-792-2817
For General Questions about Clinical Trials:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)


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