Trial reportThe oncologist2023
Palbociclib with Fulvestrant or Letrozole in Endocrine-Sensitive Patients with HR-Positive/HER2-Negative Advanced Breast Cancer: A Detailed Safety Analysis of the Randomized PARSIFAL Trial.
Trial report in The oncologist, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02491983 (A Randomized, Multicenter, Open-label, Phase II Trial to Evaluate the Efficacy and Safety of Palbociclib in Combination With Fulvestrant or Letrozole in Patients With HER2 Negative, ER+ Metastatic Breast Cancer), which is not on this map. Cited by 18 papers, 3 of them syntheses that pooled it.
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.
A Randomized, Multicenter, Open-label, Phase II Trial to Evaluate the Efficacy and Safety of Palbociclib in Combination With Fulvestrant or Letrozole in Patients With HER2 Negative, ER+ Metastatic Breast Cancer
Who cites it
18 citing papers in PubMed, 3 syntheses or guidelines pooled it, 19 citations in OpenAlex.
- Risk of venous thromboembolism with CDK4/6 inhibitor use in breast cancer: a systematic review and meta-analysis.The oncologist · 2026Pooled it
- Palbociclib treatment in patients with HR+/HER2- advanced or metastatic breast cancer and visceral metastasis: A systematic literature review.Breast (Edinburgh, Scotland) · 2025Pooled it
- Efficacy and Safety of Cyclin-Dependent Kinase 4/6 Inhibitors in Patients with Breast Cancer: A Systematic Review and Meta-analysis of Randomized Controlled Trials and Real-World Studies.Targeted oncology · 2025Pooled it
- Evolving First-Line Endocrine Therapy in HR+/HER2- Metastatic Breast Cancer: CDK4/6 Inhibition, Biomarker-Guided Strategies and Emerging Therapeutic Paradigms.Current oncology (Toronto, Ont.) · 2026Review
- Spatial transcriptome revealed associated biomarkers for endocrine therapy response in HR-positive/HER2-negative early breast cancer.Chinese journal of cancer research = Chung-kuo yen cheng yen chiu · 2026Article
- Efficacy of CDK4/6 Inhibitor Plus Aromatase Inhibitor versus Fulvestrant in Chinese Patients with Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative (HR+/HER2-) Advanced Breast Cancer.Breast cancer (Dove Medical Press) · 2026Article
- Cardiovascular toxicity of CDK4/6 inhibitors combined with endocrine therapy versus endocrine therapy alone in HR+/HER2- breast cancer: a real-world study based on the FAERS database.Frontiers in pharmacology · 2026Article
- Antineoplastic agent-associated interstitial lung disease in breast, ovarian, and prostate cancers: a pharmacovigilance study using the FDA adverse event reporting system.Frontiers in immunology · 2026Article
- Article
- CDK4/6 as a Therapeutic Target in HR+/HER2- Breast Cancer Cells-Current Treatment Status.Cancers · 2025Review
- Options after progression on first-line CDK4/6 inhibitors in advanced breast cancer patients.Therapeutic advances in medical oncology · 2025Article
- Development and validation of nomograms for predicting grade ≥3 diarrhea and neutropenia after abemaciclib combined with endocrine therapy for breast cancer: a multicenter retrospective real-world study.Frontiers in oncology · 2025Article
- Toxicity profiles of cyclin-dependent kinase 4/6 inhibitors: safety analysis from clinical trials and the FDA adverse event reporting system.Frontiers in oncology · 2025Article
- Part 2 - Highlights of the San Antonio Breast Cancer Symposium 2023.Future oncology (London, England) · 2024Article
- Recent progress of CDK4/6 inhibitors' current practice in breast cancer.Cancer gene therapy · 2024Review
- Adverse event signal mining and serious adverse event influencing factor analysis of fulvestrant based on FAERS database.Scientific reports · 2024Article
- Targeting regulated cell death pathways in cancers for effective treatment: a comprehensive review.Frontiers in cell and developmental biology · 2024Review
- Update Breast Cancer 2022 Part 6 - Advanced-Stage Breast Cancer.Geburtshilfe und Frauenheilkunde · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
23 authors at 17 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPalbociclib has gained a central role in the treatment of hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC). Despite its manageable toxicity profile, venous thromboembolism (VTE) or interstitial lung disease (ILD)/pneumonitis may infrequently occur. Therefore, we provide a comprehensive summary of the safety and tolerability of the combination of endocrine therapy and palbociclib among patients included in the randomized phase 2 PARSIFAL study. MATERIALS AND
methodsPatients with endocrine-sensitive HR+/HER2- ABC and no prior therapy in an advanced setting (n = 486) were randomly assigned 1:1 to receive fulvestrant-palbociclib (FP) or letrozole-palbociclib (LP). Laboratory tests and the incidence of adverse events (AEs) were recorded at baseline and day 1 of each cycle. Progression-free survival (PFS) was estimated for patients with and without VTE.
resultsA total of 483 patients were analyzed. Neutropenia, leukopenia, anemia, asthenia, arthralgia, fatigue, and diarrhea were the most frequent AEs in both groups. Febrile neutropenia occurred in 3 (1.2%) patients of the FP group and in 1 (0.4%) patient in the LP group. Six (2.5%; 0.4% grade 3) patients in the FP group and 6 patients (2.5%; 0.4% grade 3) in the LP group experienced ILD/pneumonitis. Pulmonary embolism was reported in 12 (5.0%) patients in the FP group and 6 (2.5%) patients in the LP group. Advanced age at baseline was the only factor significantly associated with an increased risk of pulmonary embolism (P < .01).
conclusionThe PARSIFAL data confirmed the favorable safety profile of both palbociclib regimens. VTE and ILD/pneumonitis were occasionally reported, and their early detection allowed patients to continue treatment effectively without detriment to efficacy. CLINICALTRIALS.GOV IDENTIFIER: NCT02491983; https://clinicaltrials.gov/ct2/show/NCT02491983).
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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.