Trial reportBreast cancer research and treatment2021
Safety and efficacy of abemaciclib plus endocrine therapy in older patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer: an age-specific subgroup analysis of MONARCH 2 and 3 trials.
Trial report in Breast cancer research and treatment, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 37 papers, 2 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.
MONARCH 2: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Fulvestrant With or Without Abemaciclib, a CDK4/6 Inhibitor, for Women With Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Nonsteroidal Aromatase Inhibitors (Anastrozole or Letrozole) Plus LY2835219, a CDK4/6 Inhibitor, or Placebo in Postmenopausal Women With Hormone Receptor-Positive, HER2-Negative Locoregionally Recurrent or Metastatic Breast Cancer With No Prior Systemic Therapy in This Disease Setting
Who cites it
37 citing papers in PubMed, 2 syntheses or guidelines pooled it, 53 citations in OpenAlex.
- Guidance for Canadian Breast Cancer Practice: National Consensus Recommendations for the Systemic Treatment of Patients with HR+/HER2- Metastatic Breast Cancer 2025.Current oncology (Toronto, Ont.) · 2026Guideline
- The role of CDK4/6 inhibitors in older and younger patients with breast cancer: A systematic review and meta-analysis.Breast (Edinburgh, Scotland) · 2023Pooled it
- Japanese subgroup analysis of the phase 3 MONARCH 3 study of abemaciclib as initial therapy for patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer.Breast cancer (Tokyo, Japan) · 2022Trial
- Real-world effectiveness of CDK4/6 inhibitors in older patients with HR+/HER2- advanced breast cancer: a sub-analysis of the multicenter, PALMARES-2 study.Breast (Edinburgh, Scotland) · 2026Observational
- Imlunestrant with or without abemaciclib in advanced breast cancer: safety analyses from the EMBER-3 trial.NPJ breast cancer · 2026Article
- A prospective post-marketing observational study of abemaciclib in patients with HR+, HER2- breast cancer in China.The oncologist · 2026Observational
- Clinical outcomes and toxicity in metastatic breast cancer patients treated with first or second-line cyclin-dependent kinase (CDK) 4/6 inhibitors and endocrine therapy in Egypt.The Pan African medical journal · 2026Observational
- Prescribing patterns and real-world clinical usage of adjuvant abemaciclib for early-stage, high-risk, hormone receptor-positive breast cancer.JCO oncology advances · 2026Article
- Collateral damage: rhabdomyolysis from concurrent abemaciclib and rosuvastatin use.Breast cancer research and treatment · 2025Article
- Cost-effectiveness analysis of Anastrozole combined with Abemaciclib for the treatment of postmenopausal hormone receptor-positive advanced breast cancer.Cost effectiveness and resource allocation : C/E · 2025Article
- Real-world treatment outcomes of abemaciclib in older patients with HR+, HER2- metastatic breast cancer in Japan.Future oncology (London, England) · 2025Article
- CDK inhibitors promote neuroblastoma cell differentiation and increase sensitivity to retinoic acid-a promising combination strategy for therapeutic intervention.Cell death discovery · 2025Article
- Real-world evidence from Japan regarding survival outcomes and treatment sequence in patients receiving CDK4/6 inhibitor plus endocrine therapy as first- or second-line treatment for hormone receptor-positive, HER2-negative advanced or metastatic breast cancer.Breast cancer (Tokyo, Japan) · 2025Observational
- Article
- 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
- Risk factors for adverse reactions caused by abemaciclib in breast cancer therapy.Frontiers in oncology · 2025Article
- Activity of CDK4/6 inhibitors and parameters affecting survival in elderly patients in age-subgroups: Turkish Oncology Group (TOG) retrospective study.BMC cancer · 2024Article
- The treatment pattern of advanced HR-positive and HER2-negative breast cancer in central southern China: a hospital-based cross-sectional study.BMC cancer · 2024Article
- Clinical impact of drug-drug interactions on abemaciclib in the real-world experience of AB-ITALY study.NPJ breast cancer · 2024Article
- Elderly patients with hormone receptor-positive HER2-negative metastatic breast cancer treated with CDK4/6 inhibitors in a multicentre cohort.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2024Observational
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 8 institutions in 6 countries.
Funding
Abstract
purposeAbemaciclib in combination with endocrine therapy (ET) has demonstrated significant efficacy benefits in HR+ , HER2- advanced breast cancer patients in the Phase 3 studies MONARCH 2 (fulvestrant as ET) and MONARCH 3 (letrozole or anastrozole as ET). Here, we report age-specific safety and efficacy outcomes.
methodsExploratory analyses of MONARCH 2 and 3 were performed for 3 age groups (<65, 65-74, and ≥75 years). For safety, data were pooled from both studies; for efficacy, a subgroup analysis of PFS was performed for each trial independently.
resultsPooled safety data were available for 1152 patients. Clinically relevant diarrhea (Grade 2/3) was higher in older patients receiving abemaciclib + ET (<65, 39.5%; 65-74, 45.2%; ≥75, 55.4%) versus placebo + ET (<65, 6.8%; 65-74, 4.5%; ≥75, 16.0%). Nausea, decreased appetite, and venous thromboembolic events were all moderately higher in older patients. Neutropenia (Grade ≥ 3) did not differ as a function of age in the abemaciclib + ET arm (<65, 25.8%; 65-74, 27.4%; ≥75, 18.1%). Dose adjustments and discontinuation rates were slightly higher in older patients. Abemaciclib + ET improved PFS compared with placebo + ET independent of patient age, with no significant difference in abemaciclib treatment effect between the 3 age groups (MONARCH 2: interaction p-value, 0.695; MONARCH 3: interaction p-value, 0.634). Estimated hazard ratios ranged from 0.523-0.633 (MONARCH 2) and 0.480-0.635 (MONARCH 3).
conclusionsWhile higher rates of adverse events were reported in older patients, they were manageable with dose adjustments and concomitant medication. Importantly, a consistent efficacy benefit was observed across all age groups. CLINICAL
trial registrationClinicalTrials.gov: NCT02107703 (first posted April 8, 2014) and NCT02246621 (first posted September 23, 2014).
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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.