Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Abemaciclib; 1-0-1 per os · 1 trial · 1 indication
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...
Abemaciclib is an investigational small molecule being studied for use in female breast cancer. It is currently in Phase 3 clinical development as adjuvant therapy for patients with clinical or genomic high risk, hormone receptor positive, HER2 negative early breast cancer. The drug is administered orally.
Abemaciclib is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The company is conducting a Phase 3 clinical trial to evaluate the drug in the adjuvant treatment of breast cancer.
Abemaciclib is in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The ongoing Phase 3 trial is evaluating its use as adjuvant therapy in high risk, hormone receptor positive, HER2 negative early breast cancer.
Abemaciclib is being studied in a Phase 3 clinical trial with the identifier NCT04565054. This trial is active but not recruiting participants, with an enrollment of 1,260 female patients. The study is being conducted in Germany, Poland, and Spain, and is comparing abemaciclib plus standard endocrine therapy versus standard endocrine therapy alone.
Yes, Abemaciclib 50 MG and 150mg 1-0-1 per os are alternative names for the same drug, Abemaciclib. The dosing regimen 1-0-1 per os indicates the drug is taken orally, once in the morning and once in the evening, with the specific strength depending on the prescribed dose.
Abemaciclib is a small molecule that targets cyclin-dependent kinases, which are enzymes involved in cell cycle regulation. By inhibiting these kinases, the drug aims to slow or stop the growth of cancer cells. This mechanism is being evaluated in the context of hormone receptor positive, HER2 negative breast cancer.