Trial reportAnti-cancer drugs2018
Palbociclib has no clinically relevant effect on the QTc interval in patients with advanced breast cancer.
Trial report in Anti-cancer drugs, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 1 of them a synthesis 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
21 citing papers in PubMed, 1 synthesis or guideline pooled it, 44 citations in OpenAlex.
- QTc prolongation across CDK4/6 inhibitors: a systematic review and meta-analysis of randomized controlled trials.JNCI cancer spectrum · 2024Pooled it
- Long-term Pooled Safety Analysis of Palbociclib in Combination With Endocrine Therapy for HR+/HER2- Advanced Breast Cancer.Journal of the National Cancer Institute · 2019Trial
- Cardiovascular event burden in women with breast cancer treated with CDK4/6 inhibitors: a retrospective matched cohort study.Cardio-oncology (London, England) · 2026Article
- Local Control of Advanced Breast Cancer-Debate in Multidisciplinary Tumor Board.Journal of clinical medicine · 2025Article
- Palbociclib plus aromatase inhibitors in patients with metastatic breast cancer and cardiovascular diseases: real-world effectiveness.The oncologist · 2024Observational
- Palbociclib: Randomized Studies and Real-world Evidence as the Basis for Therapeutic Planning in Metastatic Breast Cancer.Geburtshilfe und Frauenheilkunde · 2024Article
- Cardiac safety of ribociclib evaluated with 24-hour rhythm Holter electrocardiogram.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2024Article
- Strategy of combining CDK4/6 inhibitors with other therapies and mechanisms of resistance.International journal of clinical and experimental pathology · 2024Review
- CDK4/6 inhibitors: basics, pros, and major cons in breast cancer treatment with specific regard to cardiotoxicity - a narrative review.Therapeutic advances in medical oncology · 2023Review
- Letrozole targets the human ether-a-go-go-related gene potassium current in glioblastoma.Basic & clinical pharmacology & toxicology · 2021Article
- Review
- Clinical and Pharmacologic Differences of CDK4/6 Inhibitors in Breast Cancer.Frontiers in oncology · 2021Review
- Treatment of Advanced Hormone Receptor-Positive (HR+) HER2-negative Breast Cancer.Geburtshilfe und Frauenheilkunde · 2019Article
- Prevention, Monitoring, and Management of Cardiac Dysfunction in Patients with Metastatic Breast Cancer.The oncologist · 2019Review
- Cardiotoxicities of Modern Treatments in Breast Cancer.Current treatment options in cardiovascular medicine · 2019Review
- Talazoparib has no clinically relevant effect on QTc interval in patients with advanced solid tumors.Anti-cancer drugs · 2019Article
- Management of Adverse Events Due to Cyclin-Dependent Kinase 4/6 Inhibitors.Breast care (Basel, Switzerland) · 2019Review
- Palbociclib and ribociclib in breast cancer: consensus workshop on the management of concomitant medication.Therapeutic advances in medical oncology · 2019Review
- Cyclin-Dependent Kinases 4/6 Inhibitors in Breast Cancer: Current Status, Resistance, and Combination Strategies.Journal of Cancer · 2019Article
- Updates on managing advanced breast cancer with palbociclib combination therapy.Therapeutic advances in medical oncology · 2018Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 6 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The aim of this study was to assess the potential effects of palbociclib in combination with letrozole on QTc. PALOMA-2, a phase 3, randomized, double-blind, placebo-controlled trial, compared palbociclib plus letrozole with placebo plus letrozole in postmenopausal women with estrogen receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer. The study included a QTc evaluation substudy carried out as a definitive QT interval prolongation assessment for palbociclib. Time-matched triplicate ECGs were performed at 0, 2, 4, 6, and 8 h at baseline (Day 0) and on Cycle 1 Day 14. Additional ECGs were collected from all patients for safety monitoring. The QT interval was corrected for heart rate using Fridericia's correction (QTcF), Bazett's correction (QTcB), and a study-specific correction factor (QTcS). In total, 666 patients were randomized 2 : 1 to palbociclib plus letrozole or placebo plus letrozole. Of these, 125 patients were enrolled in the QTc evaluation substudy. No patients in the palbociclib plus letrozole arm of the substudy (N=77) had a maximum postbaseline QTcS or QTcF value of ≥ 480 ms, or a maximum increase from clock time-matched baseline for QTcS or QTcF values of ≥ 60 ms. The upper bounds of the one-sided 95% confidence interval for the mean change from time-matched baseline for QTcS, QTcF, and QTcB at all time points and at steady-state Cmax following repeated administration of 125 mg palbociclib were less than 10 ms. Palbociclib, when administered with letrozole at the recommended therapeutic dosing regimen, did not prolong the QT interval to a clinically relevant extent.
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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.