Trial reportJournal of the National Cancer Institute2019
Long-term Pooled Safety Analysis of Palbociclib in Combination With Endocrine Therapy for HR+/HER2- Advanced Breast Cancer.
Trial report in Journal of the National Cancer Institute, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 57 papers, 6 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.
Phase 1/2, open-label, randomized study of the safety, efficacy, and pharmacokinetics of letrozole plus pd 0332991 (oral cdk 4/6 inhibitor) and letrozole single agent for the first-line treatment of er positive, her2 negative advanced breast cancer in postmenopausal women
A randomized, multicenter, double-blind phase 3 study of pd-0332991 (oral cdk 4/6 inhibitor) plus letrozole versus placebo plus letrozole for the treatment of postmenopausal women with er (+), her2 (-) breast cancer who have not received any prior systemic anti cancer treatment for advanced disease
Multicenter, randomized, double-blind, placebo-controlled, phase 3 trial of fulvestrant (faslodex (registered)). with or without pd-0332991 (palbociclib) +/- goserelin in women with hormone receptor-positive, her2-negative metastatic breast cancer whose disease progressed after prior endocrine therapy
PALbociclib CoLlaborative Adjuvant Study: A Randomized Phase III Trial of Palbociclib With Standard Adjuvant Endocrine Therapy Versus Standard Adjuvant Endocrine Therapy Alone for Hormone Receptor Positive (HR+) / Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Early Breast Cancer
Who cites it
57 citing papers in PubMed, 6 syntheses or guidelines pooled it.
- Risk of venous thromboembolism with CDK4/6 inhibitor use in breast cancer: a systematic review and meta-analysis.The oncologist · 2026Pooled it
- CDK4/6 Inhibition in the Management of Metastatic HR+/HER2+ Breast Cancer: Systematic Review and Meta-analysis.Targeted oncology · 2026Pooled it
- Association of germlineFrontiers in pharmacology · 2026Pooled it
- Adverse Event Costs and Cost-Effectiveness Analyses of Anticancer Drugs: A Systematic Review.JAMA network open · 2025Pooled it
- Dose reduction and discontinuation due to the combination of CDK4/6 inhibitors and endocrine drugs: a systematic review and meta-analysis.European journal of clinical pharmacology · 2024Pooled it
- Endocrine Treatment and Targeted Therapy for Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer: ASCO Guideline Update.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2021Pooled it
- Trial
- Continuous versus Standard Palbociclib Treatment and Molecular Profiling of Solid Tissues and Liquid Biopsies in the CCTG MA.38 Trial in Advanced Breast Cancer.Cancer research communications · 2025Trial
- Bioequivalence Study of Palbociclib Tablets in Healthy Volunteers.Drug design, development and therapy · 2025Trial
- Initial ribociclib plus endocrine therapy for HR+/HER2- advanced breast cancer in pre- and postmenopausal Chinese women: Primary results from a phase 2 randomized study.Cancer medicine · 2024Trial
- Trial
- Overall survival results from the randomized phase 2 study of palbociclib in combination with letrozole versus letrozole alone for first-line treatment of ER+/HER2- advanced breast cancer (PALOMA-1, TRIO-18).Breast cancer research and treatment · 2020Trial
- Hematologic adverse events following palbociclib dose reduction in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer: pooled analysis from randomized phase 2 and 3 studies.Breast cancer research : BCR · 2020Trial
- First- Versus Second- or Subsequent-Line Use of Cyclin-Dependent Kinase 4/6 Inhibitors for Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Metastatic or Recurrent Breast Cancer: A Multicenter, Retrospective Cohort Study.Medicina (Kaunas, Lithuania) · 2026Article
- Real-World Outcomes of Elacestrant in ER+, HER2-, ESR1-Mutant Metastatic Breast Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026Article
- MCV-Neutropenia Risk Score and Overall Survival in HR+/HER2- Advanced Breast Cancer: A Multicenter Retrospective Landmark Analysis.Breast cancer (Dove Medical Press) · 2026Article
- Health-related quality of life and physical activity collected via mobile application and wearable device in patients with HR +/HER2 - advanced breast cancer treated with palbociclib plus endocrine therapy or endocrine therapy alone: 6-month longitudinal study (JBCRG-26).Breast cancer (Tokyo, Japan) · 2025Observational
- Incidence of patient-reported fatigue developing on palbociclib and endocrine therapy for advanced HR+ HER2- breast cancer.The oncologist · 2025Article
- Hepatotoxicity across CDK 4/6 inhibitors: a Narrative Review.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2025Review
- Identification of novel cyclin-dependent kinase 4/6 inhibitors from marine natural products.PloS one · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPalbociclib administered with endocrine therapy was tolerable when the overall incidence of toxicities was assessed separately for three PALOMA studies. This study analyzed pooled, longer-term PALOMA safety data longitudinally.
methodsData were pooled from three randomized phase II and III studies (ClinicalTrials.gov: NCT00721409, NCT01740427, NCT01942135) of hormone receptor-positive/human epidermal growth factor receptor 2‒negative advanced breast cancer patients. Front-line patients were randomly assigned to receive letrozole with/without palbociclib (PALOMA-1) or letrozole plus palbociclib/placebo (PALOMA-2). In PALOMA-3, patients with prior endocrine resistance received fulvestrant plus palbociclib/placebo. The cumulative event rates of adverse events (AEs), reporting up to 50 months of treatment, were assessed over time.
resultsPatients who received endocrine therapy (n = 1343) were included in this pooled analysis (872 were also treated with palbociclib, and 471 were not). The most common AEs with palbociclib plus endocrine therapy were neutropenia and infections (any grade, 80.6% and 54.7%, respectively), which were higher than in the endocrine monotherapy arm (any grade, 5.3% and 36.9%). The most common hematologic AEs (≥15.0% in the palbociclib arm) were more likely to be reported in the initial months of the study, after which time the cumulative event rate did not substantially increase. With palbociclib plus endocrine therapy, any grade AEs leading to permanent discontinuation over three years occurred in only 8.3% of patients.
conclusionsBased on these long-term safety analyses, there is no evidence of specific cumulative or delayed toxicities with palbociclib plus endocrine therapy, supporting the ongoing investigation of palbociclib plus endocrine therapy in early breast cancer (NCT02513394).
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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.