Phase 1b/2 Trial Using Lapatinib, Everolimus and Capecitabine for Treatment of HER-2 Positive Breast Cancer With CNS Metastasis

Summary

This is a phase 1b/2 study to evaluate the safety and clinical activity of the combination of lapatinib, everolimus and capecitabine for the treatment of participants with HER2+ breast cancer with metastases in the brain who have progressed on trastuzumab. The combination of 2 drugs able to reach the brain (lapatinib and everolimus) that target different parts of the HER2 signaling pathway plus chemotherapy (capecitabine) that has proven benefits in metastatic breast cancer may lead to improved clinical outcomes for participants with CNS metastasis. Participants will undergo brain MRIs and CT scans of the chest and abdomen to evaluate response to the treatment, regular laboratory tests and echocardiogram or Multi Gated Acquisition Scan (MUGA) to assess cardiac activity

Timeline

Start

2013-06-26

Primary completion

2019-05-10

Completion

2019-05-10

Publications

• Hurvitz S, Singh R, Adams B, Taguchi JA, Chan D, Dichmann RA, Castrellon A, Hu E, Berkowitz J, Mani A, DiCarlo B, Callahan R, Smalberg I, Wang X, Meglar I, Martinez D, Hobbs E, Slamon DJ. Phase Ib/II single-arm trial evaluating the combination of everolimus, lapatinib and capecitabine for the treatment of HER2-positive breast cancer with brain metastases (TRIO-US B-09). Ther Adv Med Oncol. 2018 Nov 9;10:1758835918807339. doi: 10.1177/1758835918807339. eCollection 2018.

Drugs

Indications