Recurrent Breast Carcinoma Clinical Trial
Official 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
This phase I trial studies the side effects and best dose of entinostat when given together with lapatinib ditosylate and trastuzumab in treating patients with breast cancer that has spread from the original (primary) tumor to distant organs or distant lymph nodes or has recurred (come back) at or near the same place as the original (primary) tumor, usually after a period of time during which the cancer could not be detected. Entinostat and lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as trastuzumab, may interfere with the ability of tumor cells to grow and spread. Giving entinostat together with lapatinib ditosylate and trastuzumab may kill more tumor cells.
PRIMARY OBJECTIVES:
I. To determine the recommended phase II dose (RP2D) for entinostat in combination with
lapatinib (lapatinib ditosylate) in patients whom trastuzumab has failed for human epidermal
growth factor receptor 2+ (HER2+) metastatic breast cancer (Phase I).
II. To determine the maximum tolerated dose (MTD) for entinostat in combination with
lapatinib and trastuzumab in patients whom trastuzumab has failed for HER2+ metastatic breast
cancer (Phase I Trastuzumab Cohort).
SECONDARY OBJECTIVES:
I. To determine the toxicity of combination therapy with entinostat and lapatinib in patients
whom trastuzumab has failed for HER2+ metastatic breast cancer (Phase I).
II. To determine the toxicity of entinostat in combination with lapatinib and trastuzumab in
patients whom trastuzumab has failed for HER2+ metastatic breast cancer (Phase I Trastuzumab
Cohort).
EXPLORATORY OBJECTIVES:
I. Determine whether the 2-drug combination modulates the expression of HER2, phosphorylated
HER2 (pHER), epidermal growth factor receptor (EGFR), phosphorylated EGFR (pEGFR), v-akt
murine thymoma viral oncogene homolog 1 (Akt), and phosphorylated Akt (pAkt) in breast tumors
and/or circulating tumor cells (CTCs).
OUTLINE: This is a dose-escalation study of entinostat.
Patients receive entinostat orally (PO) on days 1 and 15 and lapatinib tosylate PO on days
1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable
toxicity. Patients in the Phase I trastuzumab cohort also receive maintenance dose of
trastuzumab intravenously (IV) over 30-90 minutes every 3 weeks.
After completion of study treatment, patients are followed up for 28 days or until toxicities
are resolved.
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