drugset / Trial / NCT04351230

T-DM1 With or Without Abemaciclib for the Treatment of HER2-Positive Metastatic Breast Cancer

NCT04351230

RandomizedParallel-groupOpen-labelTreatment

Summary

This phase II trial studies how well T-DMI with or without abemaciclib works for the treatment of HER2-positive breast cancer that has spread to other places in the body (metastatic). T-DM1 is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug called DM1. Trastuzumab attaches to HER2 positive cancer cells in a targeted way and delivers DM1 to kill them. Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving T-DM1 and abemaciclib may work better in treating patients with breast cancer compared to T-DM1 alone.

Timeline

Start
2020-11-11
Primary completion
2022-02-16
Completion
2022-02-16

Drugs

EvaluationDrugModalityDoseRoute
Subject Abemaciclib Small molecule Intravenous
Subject Trastuzumab emtansine Other / unclassified Oral