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

Conditions

Breast Cancer

Keywords

Retrospective, Multicenter, Observational, Effectiveness, Real-world progression free survival, Palbociclib, Endocrine therapy, Japan, Hormone receptor positive/ human epidermal growth factor negative (HR+/HER2-), Advanced Breast Cancer, First-line therapy, Second-Line therapy

Brief 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.

Shigenori E. Nagai, Masaya Hattori, Tetsuhiro Yoshinami, Hiroko Masuda, Takuho Okamura et al. (23 authors)

Breast Cancer2025-04-05

10.1007/s12282-025-01689-4

Abstract PO3-04-10: Real-world progression-free survival and overall survival of palbociclib plus endocrine therapy in Japanese patients with HR+/HER2- ABC in the first- or second-line setting: A multicenter observational study

Norikazu Masuda, Masaya Hattori, Tersuhiro Yoshinami, Takuho Okamura, Kenichi Watanabe et al. (23 authors)

Cancer Research2024-05-021 citations

10.1158/1538-7445.sabcs23-po3-04-10

Real-world progression-free survival and overall survival of palbociclib plus endocrine therapy (ET) in Japanese patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer in the first-line or second-line setting: an observational study.

Yoshinami T, Nagai SE, Hattori M, Okamura T, Watanabe K, Nakayama T, Masuda H, Tsuneizumi M, Takabatake D, Harao M, Yoshino H, Mori N, Yasojima H, Oshiro C, Iwase M, Yamaguchi M, Sangai T, Kosaka N, Tajima K, Masuda N.

2024-04-209 citations

10.1007/s12282-024-01575-5

Interventions

DRUGPalbociclib

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

DRUGEndocrine therapy

Palbociclib plus ET as first-line/second-line treatment for HR+/HER2- ABC

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* Diagnosis of HR+/HER2- ABC * Age of 20 years or older at diagnosis of ABC * Patients that received palbociclib plus ET in the first line or second line * Patients who meet the criteria regarding the medical record below: * Patients with any medical records (regardless of palbociclib use) for more than 6 months from palbociclib initiation OR * Patients with any medical records for less than 6 months from palbociclib initiation AND who had specific events (death, disease progression, or treatment discontinuation of palbociclib due to adverse events) in the available records

Exclusion criteria

* Patients who received chemotherapy as first line treatment. * Patients who have previously participated or are participating in any interventional clinical trials that include investigational or marketed products. (Interventional clinical trials for early breast cancer and later line after palbociclib will be acceptable, Besides, patients participating in other investigator-initiated research or noninterventional studies can be included as long as their standard of care is not altered by the study.)

Design outcomes

Primary

Measure	Time frame
Real-World Progression-Free Survival (rwPFS) of palbociclib plus ET as first line treatment for HR+/HER2- ABC	15 December 2017 to 31 August 2023
rePFS of palbociclib plus ET as second line treatment for HR+/HER2- ABC	15 December 2017 to 31 August 2023

Secondary

Measure	Time frame
Landmark overall survival (OS) (defined from palbociclib initiation to death) of palbociclib plus ET as first line treatment for HR+/HER2- ABC	15 December 2017 to 31 August 2023
Landmark OS (defined from palbociclib initiation to death)of palbociclib plus ET as second line treatment for HR+/HER2- ABC	15 December 2017 to 31 August 2023
Landmark OS (defined from treatment initiation of first line to death) when palbociclib plus ET were used as second line treatment for HR+/HER2- ABC	15 December 2017 to 31 August 2023
Time to treatment discontinuation (TTD) of palbociclib plus ET as first line or second line treatment for HR+/HER2- ABC	15 December 2017 to 31 August 2023
TTD of first subsequent treatment for HR+/HER2- ABC patients who were treated with palbociclib plus ET	15 December 2017 to 31 August 2023
Time to chemotherapy (TTC: defined as the time from treatment initiation of first or second line for HR+/HER2- ABC to first use of chemotherapy)	15 December 2017 to 31 August 2023
Real-world objective response rate (rwORR) of palbociclib plus ET as first line or second line treatment for HR+/HER2- ABC	15 December 2017 to 31 August 2023
Demographic of HR+/HER2- ABC patients who were treated with palbociclib plus ET in routine clinical practice in Japan	15 December 2017 to 31 August 2023
Clinical characteristics of HR+/HER2- ABC patients who were treated with palbociclib plus ET in routine clinical practice in Japan	15 December 2017 to 31 August 2023
Treatment patterns of palbociclib plus ET in routine clinical practice in Japan	15 December 2017 to 31 August 2023

Countries

Japan

Contacts

STUDY_DIRECTORPfizer CT.gov Call Center

Pfizer

Outcome results

None listed