A Multinational Observational Study Characterizing Utilization and Effectiveness Outcomes in Patients with Metastatic Breast Cancer Receiving Abemaciclib

A Multinational Observational Study Characterizing Utilization and Effectiveness Outcomes in Patients with Metastatic Breast Cancer Receiving Abemaciclib - A Multinational Observational Study Characterizing Utilization and Effectiveness Outcomes in Patients with Metastatic Breast Cancer Receiving Abemaciclib

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000049797

Enrollment

900

Registered

2022-12-15

Start date

2023-01-04

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The patient population that will be selected and observed in the study must fulfil all the following criteria: 1. Provision of subject informed consent (or consent from next of kin/legal representative, if applicable) for use of the data and according to local regulations 2. Adult patients (age of majority in the country of interest) 3. Patient with histologically confirmed HR+/HER2- ABC by physician 4. Patients who initiated treatment with abemaciclib (combination therapy) between in country drug availability and 31st December 2021.

Exclusion criteria

Exclusion criteria: 1. Patients who received treatment with abemaciclib as part of a clinical trial 2. Patients who participated in a clinical trial any time after the initiation of abemaciclib treatment 3. Patients who benefited from an early access program for abemaciclib treatment

Design outcomes

Primary

Measure	Time frame
PFS, TFST, ORR, CBR	—

Secondary

Measure	Time frame
population, index date, OS	—

Countries

Japan,Europe

Contacts

Public ContactJunji Tsurutani

Showa University Advanced Cancer Translational Research Institute

tsurutaj@med.showa-u.ac.jp03-33784-8145

Outcome results