Observational studyBreast cancer (Tokyo, Japan)2024
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.
Observational study in Breast cancer (Tokyo, Japan), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05399329 (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), which is not on this map. Cited by 14 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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
Who cites it
14 citing papers in PubMed, 11 citations in OpenAlex.
- Quality of life with palbociclib plus tamoxifen in hormone receptor-positive, HER2-negative advanced breast cancer: results from PATHWAY, an Asian international, double-blind, randomized phase 3 trial.Breast cancer (Tokyo, Japan) · 2026Trial
- Overall survival and subsequent therapy patterns in Japanese patients with ER+/HER2- advanced breast cancer treated with palbociclib plus letrozole in the first-line setting: a final analysis.Breast cancer (Tokyo, Japan) · 2025Trial
- Review
- Real-world data for a CDK4/6 inhibitor, palbociclib, as 1st- or 2nd-line therapy in HR+/HER2- metastatic breast cancer: a multicenter prospective cohort study.Breast cancer research : BCR · 2026Observational
- The effects of Palbociclib and Ferulic acid combination on cellular processes in breast cancer.Discover oncology · 2026Article
- Clinical Applications of CDK4/6 Inhibitors in HR+/HER2, and Personalized Treatment Strategies: A Narrative Review.Oncology research · 2026Review
- Efficacy and safety of dalpiciclib combined with endocrine therapy in elderly patients with HRFrontiers in oncology · 2026Article
- Clinical significance on switching CDK4/6 inhibitors among 13,284 patients with metastatic breast cancer.Breast cancer (Tokyo, Japan) · 2025Article
- Overall survival of palbociclib plus endocrine therapy in Japanese patients with HR+/HER2- advanced breast cancer in the first-or second-line setting: a multicenter observational study (P-BRIDGE study).Breast cancer (Tokyo, Japan) · 2025Observational
- Real-world evidence from Japan regarding survival outcomes and treatment sequence in patients receiving CDK4/6 inhibitor plus endocrine therapy as first- or second-line treatment for hormone receptor-positive, HER2-negative advanced or metastatic breast cancer.Breast cancer (Tokyo, Japan) · 2025Observational
- Real-world effectiveness of CDK4/6i in first-line treatment of HR+/HER2- advanced/metastatic breast cancer: updated systematic review.Frontiers in oncology · 2025Review
- Management Strategies and Outcomes in HR+/HER2- Metastatic Breast Cancer Receiving CDK4/6 Inhibitors and Subsequent Therapies.Breast cancer (Dove Medical Press) · 2025Article
- Timing of Dose Reductions and Survival Outcomes in Metastatic Breast Cancer Patients Treated with Cyclin-Dependent Kinase 4/6 Inhibitors.Current oncology (Toronto, Ont.) · 2024Article
- Real-world comparison of palbociclib, abemaciclib, and dalpiciclib as first-line treatments for Chinese HR+/HER2-metastatic breast cancer patients: a multicenter study (YOUNGBC-28).Therapeutic advances in medical oncology · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
20 authors at 17 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundA recent large real-world study conducted in the United States reported the effectiveness of palbociclib plus aromatase inhibitor in HR+/HER2- advanced breast cancer (ABC). However, local clinical practice and available medical treatment can vary between Japan and Western countries. Thus, it is important to investigate Japanese real-world data. This observational, multicenter study (NCT05399329) reports the interim analysis of effectiveness of palbociclib plus ET as first-line or second-line treatment for HR+/HER2- ABC by estimating real-world progression-free survival (rwPFS) and overall survival (OS) in Japanese routine clinical practice.
methodsReal-world clinical outcomes and treatment patterns of palbociclib plus ET were captured using a medical record review of patients diagnosed with HR+/HER2- ABC who had received palbociclib plus ET in the first-line or second-line treatment across 20 sites in Japan. The primary endpoint was rwPFS; secondary endpoints were OS, real-world overall response rate, real-world clinical benefit rate, and chemotherapy-free survival.
resultsOf the 677 eligible patients, 420 and 257 patients, respectively, had received palbociclib with ET as first-line and second-line treatments. Median rwPFS (95% confidence interval) was 24.5 months (19.9-29.4) for first-line and 14.5 months (10.2-19.0) for second-line treatment groups. Median OS was not reached in the first-line group and was 46.7 months (38.8-not estimated) for the second-line group. The 36-month OS rates for de novo metastasis, treatment-free interval (TFI) ≥ 12 months, and TFI < 12 months were 80.2% (69.1-87.7), 82.0% (70.7-89.3), and 66.0% (57.9-72.9), respectively.
conclusionThe addition of palbociclib to ET was effective for treating HR+/HER2- ABC in Japanese routine clinical practice.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.