NCT05399329

Study to Evaluate Real-world Effectiveness With Palbociclib Plus Endocrine Therapy as First-line/Second-line Treatment for HR+/HER2- Advanced Breast Cancer in Japan

Retrospective, Multicenter, Observational Study to Evaluate Real-World Effectiveness of Palbociclib Plus Endocrine Therapy in Japanese Patients With HR+/HER2- Advanced Breast Cancer in First Line or Second Line Settings

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 693 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

This is a retrospective, multicenter, observational study in Japan by medical record review of advanced breast cancer (ABC) patients who have received palbociclib plus endocrine therapy (ET) as first line or second line setting. For the purposes of this study, analyses will be descriptive in nature. No formal hypothesis testing is planned.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Palbociclib	Palbociclib plus ET as first-line/second-line treatment for hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) ABC
DRUG	Endocrine therapy	Palbociclib plus ET as first-line/second-line treatment for HR+/HER2- ABC

Timeline

• Start date: 2022-04-20
• Primary completion: 2025-06-27
• Completion: 2025-06-27
• First posted: 2022-06-01
• Last updated: 2026-04-09

Locations

20 sites across 1 country: Japan