Intermittent High-Dose Lapatinib in Tandem With Capecitabine for HER2 Overexpressed/Amplified Metastatic Breast Cancer With Central Nervous System (CNS) Metastases

Phase 1 Completed 11 enrolled Memorial Sloan Kettering Cancer Center Queens Cancer Center of Queens Hospital · collab University of Michigan · collab

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to see if capecitabine can be taken safely with different doses of lapatinib in patients with HER-2 positive breast cancer involving brain (brain metastases) and/or in spinal fluid (leptomeningeal disease).

Timeline

Start: 2016-01-06
Primary completion: 2021-01-22
Completion: 2021-01-22

Publications

Morikawa A, de Stanchina E, Pentsova E, Kemeny MM, Li BT, Tang K, Patil S, Fleisher M, Van Poznak C, Norton L, Seidman AD. Phase I Study of Intermittent High-Dose Lapatinib Alternating with Capecitabine for HER2-Positive Breast Cancer Patients with Central Nervous System Metastases. Clin Cancer Res. 2019 Jul 1;25(13):3784-3792. doi: 10.1158/1078-0432.CCR-18-3502. Epub 2019 Apr 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Capecitabine	Small molecule	1500 mg	Oral
Subject	Lapatinib	Small molecule	1500 mg	Oral

Intermittent High-Dose Lapatinib in Tandem With Capecitabine for HER2 Overexpressed/Amplified Metastatic Breast Cancer With Central Nervous System (CNS) Metastases

Summary

Timeline

Publications

Drugs

Indications