Clinical Trials Search
Clinical Trial 18093
Interventions:Abemaciclib; LY2835219 (Abemaciclib)
Study Type: Treatment
Phase of Study: Phase II
- Solmaz Sahebjam
A Phase 2 Study of Abemaciclib in Patients with Brain Metastases Secondary to Hormone Receptor Positive Breast Cancer
The main purpose of this study is to evaluate the safety and effectiveness of the study drug known as abemaciclib in participants with hormone receptor positive breast cancer that has spread to the brain.
Primary Objective To evaluate abemaciclib with respect to objective intracranial response rate (OIRR; complete response [CR] + partial response [PR]) based on tumor assessments and brain metastases response criteria (see Attachment 5): - In women with brain metastases secondary to HR+, HER2+ breast cancer. - In women with brain metastases secondary to HR+, HER2- breast cancer. Secondary Objectives The secondary objectives of the study are as follows: To evaluate abemaciclib with respect to: - Intracranial disease per brain metastases response criteria - Best overall intracranial response (BOIR) - Duration of intracranial response (DOIR) (CR + PR) - Intracranial disease control rate (IDCR) (CR + PR + stable disease [SD]) - Intracranial clinical benefit rate (ICBR) (CR + PR + SD >/= 6 months) - Overall - OS - Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors(RECIST) v1.1 and brain metastases response criteria - Disease control rate (DCR) (CR+ PR+ SD) per RECIST v1.1 and brain metastases response criteria - Progression-free survival (PFS) per RECIST v1.1 and brain metastases response criteria - Change in symptoms as assessed by MD Anderson Symptom Inventory - Brain Tumor (MDASI-BT) - Safety and tolerability - PK of abemaciclib and its metabolites Exploratory Objectives - To explore change in neurocognitive function as assessed by Trail Making Tests A and B - To explore change in neurologic signs as assessed by the Neurologic Assessment in euro-Oncology (NANO) scale - To explore the concentration of abemaciclib and its metabolites in plasma, cerebrospinal fluid (CSF), and brain tumor tissue collected at the time of surgical resection for patients participating in Part C, as well as patients in Parts A and B with progressive disease (PD)and planned surgical resection. - To explore biomarkers related to the mechanism of action of abemaciclib, the cell cycle,and/or the pathogenesis of breast cancer.