LI8998 Abemaciclib MBC Chart Review Study
Research type
Research Study
Full title
Observational Study on HR+/HER2- Locally Advanced / Metastatic Breast Cancer Patients treated with Abemaciclib in UK & Germany
IRAS ID
292980
Contact name
Judy King
Contact email
Sponsor organisation
Eli Lilly and Company Limited
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
0 years, 4 months, 31 days
Research summary
The purpose of this study is to explore use of abemaciclib which is a fairly new treatment option for patients with advanced/ metastatic breast cancer.
Abemaciclib has become the third approved drug of a specific class of medicines following ribociclib (Novartis) and palbociclib (Pfizer). These three drugs are known as CDK 4/6 inhibitors.
For abemaciclib, which is the newest CDK 4/6 inhibitor to become available within the NHS, it is unclear how doctors will incorporate this into their overall treatment approach. Particularly given that there are limited data showing superiority of any of these three drugs over the other. The characteristics of patients who will receive abemaciclib in the real world, including demographic and clinical characteristics and previous treatment history, remains to be explored. Similarly, the impact to the healthcare system, in terms of resource use will also be of interest for evaluating the cost benefit ratio of abemaciclib when used within the NHS.
This research project explores the use of abemaciclib in a real world setting via a retrospective chart review across multiple UK hospitals. Data will be collected from the medical records of women with advanced/ metastatic breast cancer who started treatment with abemaciclib within a specific time period. Patients must have at least 3 months of follow up data in their records since starting abemaciclib but may have terminated treatment within this timeframe or beyond. Patients themselves will not be directly involved in the research as all data will be taken from the existing records.
REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
21/YH/0061
Date of REC Opinion
11 Mar 2021
REC opinion
Favourable Opinion