Trial reportCancer science2018
Palbociclib in combination with letrozole as first-line treatment for advanced breast cancer: A Japanese phase II study.
Trial report in Cancer science, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
20 citing papers in PubMed, 36 citations in OpenAlex.
- 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
- Abemaciclib in combination with endocrine therapy for East Asian patients with HR+, HER2- advanced breast cancer: MONARCH 2 & 3 trials.Cancer science · 2021Trial
- Palbociclib-letrozole as first-line treatment for advanced breast cancer: Updated results from a Japanese phase 2 study.Cancer medicine · 2020Trial
- Neutropenia management with palbociclib in Japanese patients with advanced breast cancer.Breast cancer (Tokyo, Japan) · 2019Trial
- Palbociclib Plus Letrozole as First-Line Therapy in Postmenopausal Asian Women With Metastatic Breast Cancer: Results From the Phase III, Randomized PALOMA-2 Study.Journal of global oncology · 2019Trial
- Palbociclib in combination with letrozole in patients with estrogen receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: PALOMA-2 subgroup analysis of Japanese patients.International journal of clinical oncology · 2019Trial
- Palbociclib in combination with fulvestrant in patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: PALOMA-3 subgroup analysis of Japanese patients.International journal of clinical oncology · 2019Trial
- Palbociclib in combination with letrozole as first-line treatment for advanced breast cancer: A Japanese phase II study.Cancer science · 2018Trial
- Emerging Role of ctDNA Fragmentomics and Epigenetic Signatures in the Early Detection, Minimal Residual Disease Assessment, and Precision Monitoring of Renal Cell Carcinoma.Journal of cellular and molecular medicine · 2026Review
- 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
- Article
- Overall survival in Japanese patients with ER+/HER2- advanced breast cancer treated with first-line palbociclib plus letrozole.Breast cancer (Tokyo, Japan) · 2024Article
- Clinicopathological Features Related to the Efficacy of CDK4/6 Inhibitor-Based Treatments in Metastatic Breast Cancer.Breast cancer : basic and clinical research · 2022Article
- Exploring new pathways in endocrine-resistant breast cancer.Exploration of targeted anti-tumor therapy · 2022Review
- Palbociclib as an early-line treatment for Japanese patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer: a review of clinical trial and real-world data.International journal of clinical oncology · 2021Review
- The application and prospect of CDK4/6 inhibitors in malignant solid tumors.Journal of hematology & oncology · 2020Review
- Real-World Outcomes of Treating Advanced Breast Cancer Patients With Palbociclib: A Multicenter Retrospective Cohort Study in Japan-The KBCOG-14 Study.Breast cancer : basic and clinical research · 2020Article
- Analysis of the selection of CDK4/6 inhibitors based on experience using palbociclib.Biomedical reports · 2019Article
- Efficacy and tolerability of initial low-dose lenvatinib to treat differentiated thyroid cancer.Medicine · 2019Article
- Palbociclib in metastatic breast cancer: current evidence and real-life data.Drugs in context · 2019Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 7 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
This single-arm, open-label, phase II study in 42 Japanese postmenopausal patients with estrogen receptor-positive/human epidermal growth factor receptor 2-negative (ER+/HER2-) advanced breast cancer evaluated the efficacy, safety, and pharmacokinetics of first-line palbociclib (125 mg once daily, 3 weeks on/1 week off) coadministered with letrozole (2.5 mg once daily). Primary endpoint of investigator-assessed 1-year progression-free survival (PFS) probability was 75.0% (90% CI, 61.3%-84.4%), far surpassing the 40% lower limit of the 90% CI supporting efficacy. Median duration of treatment was 438 days. Among secondary efficacy measures, median PFS was not reached (95% CI, 16.7: not estimable), 17/42 patients (40.5%) had an objective response, 36/42 (85.7%) maintained disease control, and 27/42 (64.3%) remained in follow-up. Median overall survival was not reached, and 1-year survival probability was 92.9% (95% CI, 79.5%-97.6%). Results of intensive pharmacokinetics in a subset of 6 patients showed palbociclib steady-state mean area under the plasma concentration-time curve over the dosing interval [τ] and mean maximum plasma concentration were 1979 ng·h/mL and 124.7 ng/mL, respectively. For day 15 plasma samples from cycles 1 and 2, geometric mean of the within-patient mean trough concentration was 90.1 ng/mL. The most common treatment-related adverse events were neutropenia (100%) and stomatitis (73.8%). There was 1 case of treatment-related febrile neutropenia. Toxicities were generally tolerated and manageable by dose modifications and/or medical care. Efficacy and safety of first-line palbociclib plus letrozole therapy is supported in Japanese postmenopausal patients with treatment-naive ER+/HER2- advanced breast cancer.
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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 OpenQuestion graph.