Adjuvant Therapy With Abemaciclib + SOC ET vs. SOC ET in Clinical or Genomic High Risk, HR+/HER2- EBC
Summary
Patients with breast cancer, who have completed first line therapy (e.g., radiotherapy, chemotherapy, surgery), and who have to be identified with having a high risk of recurrence of cancer, will be eligible for the study. This patient group is currently offered a standard of care chemotherapy plus endocrine therapy (ET). The study investigates whether the patient group with high-risk early breast cancer benefits from treatment with the medication abemaciclib in combination with ET compared to ET alone.
Timeline
- Start
- 2020-09-02
- Primary completion
- 2028-06
- Completion
- 2029-07
Outcome
Met primary endpoint
release “Verzenio® (abemaciclib) in combination with standard adjuvant endocrine therapy (ET) has met the primary endpoint of invasive disease-free survival (IDFS)” lilly.com ↗
release “monarchE met its primary endpoint of a statistically significant improvement in IDFS in the ITT population” lilly.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abemaciclib | Small molecule | 150 mg | Oral |