drugset / Trial / NCT04351230
T-DM1 With or Without Abemaciclib for the Treatment of HER2-Positive Metastatic Breast Cancer
Phase 2
Withdrawn
Academic and Community Cancer Research United
National Cancer Institute (NCI) · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abemaciclib | Small molecule | — | Intravenous |
| Subject | Trastuzumab emtansine | Other / unclassified | — | Oral |