Lapatinib in Endocrine-Resistant Metastatic Breast Cancer
All patients must have stopped their endocrine two to four weeks or longer prior to entry on
study. Upon enrollment, patients will begin lapatinib at 1500 mg once a day orally. The
original endocrine therapy will resume two weeks later. The lapatinib will be continued for
a maximum of 26 weeks.
A history, physical examination, blood counts, and chemistries will be done at baseline, and
at regular intervals through the course of the study. A CT scan and bone scan will be done
prior to treatment and at weeks 14 and 26. Assays for plasma DNA will be performed on
blood sampled at baseline and at multiple time points throughout the course of treatment.
Percutaneous biopsies will be taken in selected patients with accessible disease, 72 hours
or less prior to the start of lapatinib, and again 13-15 days, and 27-29 days following the
start of lapatinib. The day 13-15 biopsy will be done just prior to the resumption of the
patient's endocrine therapy. Assays for phospho-ERK, phospho-Akt, Cyclin D1, Ki-67, and
IRS-1 will be performed by conventional immunohistochemistry on the biopsied tissue.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the response rate and progression free survival of hormone therapy-resistant patients with metastatic breast cancer treated with the same continued hormonal agent with the addition of lapatinib.
Gary N Schwartz, MD
Norris Cotton Cancer Center
United States: Food and Drug Administration
|University of Colorado Cancer Center||Denver, Colorado 80262|
|Norris Cotton Cancer Center||Lebanon, New Hampshire 03756|
|North Shore University Hospital||Manhasset, New York 11030|