Comparison of the Effectiveness of CDK4/6 Inhibitors as First-Line or Later-Line Therapy for Hormone Receptor-Positive, HER2-Negative Metastatic Recurrent Breast Cancer

Comparison of the Effectiveness of CDK4/6 Inhibitors as First-Line or Later-Line Therapy for Hormone Receptor-Positive, HER2-Negative Metastatic Recurrent Breast Cancer - Comparison of the Effectiveness of CDK4/6 Inhibitors as First-Line or Later-Line Therapy for Hormone Receptor-Positive, HER2-Negative Metastatic Recurrent Breast Cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000058459

Enrollment

Registered

2025-07-15

Start date

2025-05-19

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: 1.Patients with hormone receptor-positive, HER2-negative metastatic or recurrent breast cancer who received treatment with a single CDK4/6 inhibitor (palbociclib or abemaciclib) between March 1, 2018 and November 30, 2019. 2.Patients with hormone receptor-positive, HER2-negative metastatic or recurrent breast cancer who received two different CDK4/6 inhibitors at different treatment timings between March 1, 2018 and November 30, 2019.

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
Evaluation of treatment efficacy of one or two CDK4/6 inhibitors based on RECIST version 1.1	—

Secondary

Measure	Time frame
Overall Survival (OS):Defined as the time from the date of diagnosis of metastasis or recurrence to the date of death from any cause. Progression-Free Survival (PFS):Defined as the time from the initiation of CDK4/6 inhibitor therapy to the earliest of the following events: disease progression, death, or discontinuation of treatment due to adverse events.	—

Countries

Japan

Contacts

Public ContactTakanori Goi

University of Fukui Hospital Department of Gastrointestinal, Breast and Endocrine Surgery

tgoi@u-fukui.ac.jp0776-61-8375

Outcome results