A Prospective Post-Marketing Observational Safety Study of Verzenios® (Abemaciclib) Among Breast Cancer Patients in China Verzenios® (Abemaciclib) Among Breast

Launched by SUN YAT-SEN MEMORIAL HOSPITAL OF SUN YAT-SEN UNIVERSITY · Mar 3, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the safety of a medication called Verzenios® (Abemaciclib) in patients with breast cancer in China. The main goal is to see how often patients experience side effects (like nausea or fatigue) or serious side effects while taking Verzenios over about 24 weeks. The trial will involve around 1,500 participants who are at least 18 years old, have been diagnosed with a specific type of breast cancer (HR-positive, HER2-negative), and are starting Verzenios treatment as part of their regular care. Patients will need to provide their consent to share their health information for this study.

Participants can expect to visit the clinic several times during the trial: at the start, and then again at 4, 12, and 24 weeks to monitor their health and the effects of the treatment. Additionally, some patients will have follow-up visits after a year or two to assess long-term outcomes. It’s important to note that individuals who have previously taken Verzenios or are currently pregnant cannot participate in this study. This trial will help gather valuable information about how Verzenios works in a real-world setting and the side effects patients might face.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.