Observational studyThe oncologist2025
Real-world effectiveness of palbociclib plus endocrine therapy in HR+/HER2- advanced breast cancer: final results from the POLARIS trial.
Observational study in The oncologist, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03280303 (POLARIS), which is not on this map. Cited by 11 papers.
What it found
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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.
Polaris: palbociclib in hormone receptor positive advanced breast cancer: a prospective multicenter non-interventional study
Who cites it
11 citing papers in PubMed.
- Population Pharmacokinetic Modeling of Encorafenib in Healthy Participants and Patients with BRAF V600-Mutant Solid Tumors: A Semi-mechanistic Autoinduction Model.Clinical pharmacokinetics · 2026Article
- Observational
- A Decade After Approval of the First CDK4/6 Inhibitor: A Look Back at Palbociclib's Journey from Discovery to Approval and What's Next in CDK Inhibition in Breast Cancer.Targeted oncology · 2025Review
- Observational
- Circulating Tumor DNA Genotyping of Intrinsic and Acquired Gene Alterations in Patients With Advanced Breast Cancer Receiving Palbociclib: Biomarker Results From POLARIS Study.JCO precision oncology · 2025Article
- Relationship of Prior Anticancer Treatments with Palbociclib Clinical Outcomes in Patients with HRTargeted oncology · 2025Observational
- Oligodendrogliomas, cyclin pathway after the introduction of the molecular 2021 World Health Organization (WHO) criteria.Brain communications · 2025Article
- Real-World Outcomes of First-Line Palbociclib Plus Endocrine Therapy for HR+/HER2- Metastatic Breast Cancer in Japan: A Single-Center Retrospective Study.Oncology research · 2025Article
- Article
- Palbociclib in HR-Positive, HER2-Negative Advanced/Metastatic Breast Cancer: A Systematic Scoping Review of Real-World Evidence from Countries Outside of Western Regions that Are Underrepresented in Clinical Trials.Oncology and therapy · 2024Article
- Real-World Treatment Patterns and Clinical Outcomes among Patients Receiving CDK4/6 Inhibitors for Metastatic Breast Cancer in a Canadian Setting Using AI-Extracted Data.Current oncology (Toronto, Ont.) · 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
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundStrict eligibility criteria for participation in randomized clinical trials (RCTs) often limit the generalizability of data when applied to a more heterogeneous real-world population. Thus, evidence generated directly from real-world populations, including subgroups underrepresented in RCTs, can help inform routine clinical practice. POLARIS (NCT03280303), a prospective, observational, multicenter, cohort study, evaluated patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced breast cancer (ABC) receiving palbociclib + endocrine therapy (ET) in routine care.
methodsDemographics, baseline characteristics, and treatment patterns were summarized descriptively. Real-world response and clinical benefit rates, real-world progression-free survival (rwPFS), and overall survival (OS) were summarized descriptively by line of therapy and endocrine partner in the overall cohort and various subgroups.
resultsBetween January 2017 and October 2019, 1250 patients (median age of 64.0 years) initiated treatment with palbociclib-based therapy, including 901 in the first-line (1L) setting and 349 in the second-line or later (≥2L) settings. Real-world response and clinical benefit rates with palbociclib + ET were 34.0% and 69.4%, respectively, in 1L, and 21.8% and 57.9% in ≥2L. Median rwPFS was 20.9 (95% CI, 18.7-24.7) and 13.5 (10.6-17.1) months, and median OS was 48.5 (42.0-not estimable) and 37.2 (31.2-40.8) months, with 1L and ≥2L palbociclib + ET, respectively.
conclusionsOutcomes in this large, heterogeneous, real-world population are generally consistent with previously reported results from clinical trials and other real-world studies, further supporting the use of palbociclib + ET in patients with HR+/HER2- ABC.
trial registrationNCT03280303 (ClinicalTrials.gov).
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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.