Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04565054 | Adjuvant Therapy With Abemaciclib + SOC ET vs. SOC ET in Clinical or Genomic High Risk, HR+/HER2- EBC | PHASE3 | ACTIVE NOT_RECRUITING | 1,260 | — | — | Sep 2, 2020 | Jul 1, 2029 | Nov 19, 2025 | 85 | Germany, Poland +1 |
superiority in invasive disease-free survival (iDFS) of abemaciclib + endocrine therapy vs. standard-of-care endocrine therapy in patients with HR+/HER2- high risk breast cancer.
| Arm | Type | Description |
|---|---|---|
| Abemaciclib plus ET | EXPERIMENTAL | Abemaciclib 150 mg, 2 x daily, resulting in 300 mg/day, oral, 24 months plus endocrine treatment of physician´s choice |
| Standard-of-care ET | NO_INTERVENTION | Standard-of-care ET according to clinical guidelines. Pre-/perimenopausal patients: * Either aromatase inhibitor + GnRH agonist * or Tamoxifen +/- GnRH-agonist (as per investigator´s decision) or Postmenopausal patients: * Either Aromatase inhibitor * or Tamoxifen OR |
| Name | Type | Description |
|---|---|---|
| Abemaciclib 50 MG; 150mg 1-0-1 per os | DRUG | Experimental: Abemaciclib plus ET Abemaciclib 150 mg, 2 x daily, resulting in 300 mg/day, oral, 24 months plus endocrine treatment of physician´s choice |
Inclusion Criteria: A. Prior to REGISTRATION 1\. Written informed consent prior to any study procedures (outcomes of standard-of-care procedures performed before signing of informed consent by the patient but within allowed screening period can be used for screening of patient). 2. Female. 3. ≥ 18...