Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2025
Second-Line Endocrine Therapy With or Without Palbociclib Rechallenge in Patients With Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: PALMIRA Trial.
Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 49 papers, 3 of them syntheses that pooled it.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
49 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- CDK4/6 inhibitors rechallenge post-progression in HR-positive HER2-negative advanced/metastatic breast cancer patients: a meta-analysis of Kaplan-Meier-reconstructed individual-level data.Breast cancer research : BCR · 2026Pooled it
- [Systemic treatment of breast cancer: professional guideline].Magyar onkologia · 2025Guideline
- Systematic Review and Network Meta-Analysis on Treating Hormone Receptor-Positive Metastatic Breast Cancer After CDK4/6 Inhibitors.Current oncology (Toronto, Ont.) · 2025Pooled it
- Abemaciclib rechallenge after progression on abemaciclib plus endocrine therapy in patients with hormone receptor-positive HER2-negative metastatic breast cancer: results from the phase II again study (WJOG14220B).Breast cancer research and treatment · 2026Trial
- Imlunestrant with or without abemaciclib in advanced breast cancer: updated efficacy results from the phase III EMBER-3 trial.Annals of oncology : official journal of the European Society for Medical Oncology · 2026Trial
- Abemaciclib Plus Fulvestrant in Advanced Breast Cancer After Progression on CDK4/6 Inhibition: Results From the Phase III postMONARCH Trial.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2025Trial
- Elacestrant in ER+, HER2- Metastatic Breast Cancer with ESR1-Mutated Tumors: Subgroup Analyses from the Phase III EMERALD Trial by Prior Duration of Endocrine Therapy plus CDK4/6 Inhibitor and in Clinical Subgroups.Clinical cancer research : an official journal of the American Association for Cancer Research · 2024Trial
- Navigating first- and second-line treatment options in hormone receptor-positive HER2-negative advanced breast cancer.The oncologist · 2026Review
- Clinical benefit of palbociclib retreatment after abemaciclib exposure in hormone receptor positive, HER2 negative metastatic breast cancer.Scientific reports · 2026Article
- Rationale and Trial Design of DAWNA-FES Trial: Single-Arm Phase II Study of Endocrine Therapy With Dalpiciclib After Progression on CDK4/6 Inhibition Based on [Cancer innovation · 2026Article
- Real-world treatment durations, subsequent treatments, and switching of CDK4/6 inhibitors among patients with HR+/HER2- metastatic breast cancer.The oncologist · 2026Observational
- Article
- Treatment Patterns and Clinical Outcomes in Metastatic HR+/HER2- and Triple-Negative Breast Cancer in Canada: The HER2- TRENDS Study.Advances in therapy · 2026Article
- CDK4/6 Inhibitors for Breast Cancer Therapy-A Review of Clinical Trials, Structural and Computational Approaches.Pharmaceuticals (Basel, Switzerland) · 2026Review
- Dalpiciclib plus chidamide in HR + /HER2-advanced breast cancer after CDK4/6 inhibitor failure: a phase Ib trial.Nature communications · 2026Article
- Phase II trial of anlotinib-chemotherapy combination in pretreated HER2-negative metastatic breast cancer: therapeutic efficacy and proteomic biomarker profiling.NPJ breast cancer · 2026Article
- Efficacy and safety of treatments in HR+/HER2- advanced breast cancer after CDK4/6 inhibitor progression: a network meta-analysis and scoping review.BMC cancer · 2026Article
- Dalpiciclib combined with endocrine therapy for patients with HR+/HER2- metastatic breast cancer: a multicenter real-world study.Therapeutic advances in medical oncology · 2026Article
- Post-CDK4/6 inhibitor therapy in HR+/HER2- advanced breast cancer: expanding options and persisting uncertainties.Exploration of targeted anti-tumor therapy · 2026Review
- Efficacy, Safety, and Prognostic Factors of Dalpiciclib Combined with Endocrine Therapy After Progression on CDK4/6 Inhibitors in Patients with HR+/HER2- Advanced Breast Cancer: A Retrospective Study.Breast cancer (Dove Medical Press) · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
21 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeCyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors plus endocrine therapy (ET) represents the standard first-line treatment for patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HER2-negative) advanced breast cancer (ABC). However, there is no definitive consensus on the preferred second-line treatment option. The PALMIRA trial investigated whether palbociclib rechallenge with an alternative ET would improve the antitumor activity in patients progressing after a first-line palbociclib-containing regimen.
methodsThis international, randomized, open-label, phase II study enrolled 198 patients with hormone receptor-positive/HER2-negative ABC with disease progression after first-line palbociclib plus ET (aromatase inhibitor or fulvestrant). Patients were eligible if they showed clinical benefit to the previous regimen (response or stable disease ≥24 weeks) or had progressed on a palbociclib-based therapy in the adjuvant setting. Patients were randomly assigned (2:1 ratio) to either palbociclib rechallenge plus second-line ET (fulvestrant or letrozole) or second-line ET alone. Stratification factors were previous ET and visceral involvement. The primary end point was investigator-assessed progression-free survival (PFS).
resultsBetween April 2019 and October 2022, 136 and 62 patients were randomly assigned to palbociclib plus ET or ET alone, respectively. Median investigator-assessed PFS was 4.9 months (95% CI, 3.6 to 6.1) with palbociclib plus ET versus 3.6 months (95% CI, 2.5 to 4.2) with ET alone (hazard ratio, 0.84 [95% CI, 0.66 to 1.07];
conclusionPalbociclib rechallenge plus an alternative ET did not significantly improve PFS compared with ET alone in patients with hormone receptor-positive/HER2-negative ABC progressing on a first-line palbociclib-based ET regimen.
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