GCC 0901- A Phase II Study of Letrozole in Combination With Lapatinib Followed by an Addition of Everolimus in Postmenopausal Women With Advanced Endocrine Resistant Breast Cancer
This is a single-institution clinical trial. Patients will be stratified according to the
Group 1: HER2-positive in the tumor tissue Group 2: HER2 negative in the tumor tissue
In the first part of the study, all of the patients will receive the combination of
lapatinib 1,500 mg/day and letrozole 2.5 mg/day. We do not expect any significant toxicity
from this combination since the previous study of lapatinib and letrozole showed that this
combination is safe with no grade 3-4 toxicities observed. Restaging scans (CT scan, MRI,
or bone scan) will be obtained after every 12 weeks of treatment. In those patients who
progress from any group, everolimus 5 mg/day will be added to letrozole and lapatinib will
be reduced to 1,250 mg/day as per the SWOG phase I study of lapatinib and everolimus. The
outcome of each group will continue to be assessed separately. We do not expect to see
additional serious toxicity from adding everolimus to the combination of lapatinib and
letrozole. All of the treatment will be continued until disease progression.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Clinical benefit rate of patients treated with the combination of letrozole and lapatinib and then after progression, treated with everolimus, letrozole and lapatinib.
Clinical benefit rate is defined as complete response, partial response and stable disease. All participants will be treated with the combination of letrozole and lapatinib. Once the participant progresses on this regimen, the participant will be treated with everolimus, letrozole and lapatinib until they progress.
From date of study entry until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Saranya Chumsri, MD
University of Maryland Marlene & Stewart Greenebaum Cancer Center
United States: Institutional Review Board
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