Observational breast cancer study for Abemaciclib "ABEMA"
Research type
Research Study
Full title
A Multi-National Observational Study Characterizing Utilization and Effectiveness Outcomes in Patients with Metastatic Breast Cancer Receiving Abemaciclib
IRAS ID
316084
Contact name
Sarah Khan
Contact email
Sponsor organisation
Eli Lilly and Company
Duration of Study in the UK
1 years, 2 months, 1 days
Research summary
A multi-national observational study characterizing utilization and effectiveness outcomes in patients with metastatic breast cancer receiving abemaciclib. Study sponsored by Eli Lilly and company.
Breast cancer is the most frequently diagnosed and the second leading cause of cancer-related death among women worldwide. Its heterogenous nature determines the therapeutic options. The most common subtype reported at initial presentation is hormone receptor–positive (HR+)/human epidermal growth factor receptor-2–negative (HER2−) subtype. Abemaciclib has shown to prolong progression-free survival and overall survival with a tolerable safety profile in women with HR+/HER2− advanced breast cancer, who had progressed with endocrine therapy.
Study will be a multi-national chart review of patients, treated with abemaciclib, aiming to assess clinical effectiveness of abemaciclib and describing patients’ demographic, clinical characteristics and treatment patterns in a more diverse and heterogenous population than studied in clinical trials.
The primary objective of this non-interventional study is to describe treatment effectiveness in patients receiving abemaciclib in HR +/HER2- advanced breast cancer as per label, by line of treatment including abemaciclib, across 6 countries: France, Germany, Italy, Japan, Spain and United Kingdom. 150 patients planned to be enrolled in each country. Study objectives will be reached by abstraction of patient`s relevant data form established medical records. Data will be gathered in chart for further statistical analysis and assessment of treatment outcomes.
In UK Study will be conducted at NHS Sites, providing to public services in oncology, and will last approximately 8 months (September 2022 – June 2023). As this is an observational retrospective study, it does not impose any form of intervention. All assessments and treatment of the participants is based solely on the investigator`s usual practice in the provision of care to participants with advanced or metastatic breast cancer. No patient`s visits to study sites required, data collected will be anonymised and de-personalised.REC name
Wales REC 5
REC reference
22/WA/0280
Date of REC Opinion
7 Sep 2022
REC opinion
Favourable Opinion