Status:
NOT_YET_RECRUITING
A Prospective Post-Marketing Observational Safety Study of Verzenios® (Abemaciclib) Among Breast Cancer Patients in China Verzenios® (Abemaciclib) Among Breast
Lead Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
The Incidence of AEs and SAEs Receiving Verzenios® Over a Period of Approximately 24 Weeks
Eligibility:
All Genders
18+ years
Brief Summary
This PMSS is a single-country, prospective, observational study primarily designed to estimate the incidence of AEs and SAEs among Chinese patients with breast cancer after receiving Verzenios® over a...
Eligibility Criteria
Inclusion
- at least 18 years old at enrolment
- diagnosed with HR-positive, HER2-negative breast cancer
- prescribed with Verzenios by the investigators and started (or planned to start shortly) Verzenios treatment in the routine care of the patient
- provide written consent to the release of their data after being informed of the study.
Exclusion
- have been administered Verzenios before study enrollment
- are simultaneously participating in a different study that includes a treatment intervention and/or an investigational drug
- are pregnant or breastfeeding or intend to become pregnant within the duration of the study
- contraindicated for the use of Verzenios according to the China approved label.
Key Trial Info
Start Date :
March 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT05267327
Start Date
March 1 2022
End Date
May 1 2026
Last Update
March 4 2022
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