Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2020
Abemaciclib Combined With Endocrine Therapy for the Adjuvant Treatment of HR+, HER2-, Node-Positive, High-Risk, Early Breast Cancer (monarchE).
Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2020. 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 578 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.
Evaluation of Different Imaging Modalities in Regional Nodes Staging in Breast Cancer Patient
ONCO-ADHER: Adherence to Treatment With Aromatase Inhibitors With or Without Abemaciclib in Patients With Early-stage, Endocrine-dependent, HER2-negative Breast Cancer
Real wOrld studY in the Adjuvant Setting for High Risk earLy Breast Cancer Patients
Study on the Safety and Efficacy of Abemaciclib Dose Escalation Strategy in Adjuvant Therapy for Early High-Risk Breast Cancer
Who cites it
578 citing papers in PubMed, 3 syntheses or guidelines pooled it, 936 citations in OpenAlex.
- The impact of menopausal status on the efficacy of adjuvant CDK4/6 inhibitors in hormone receptor-positive early breast cancer: a systematic review and meta-analysis of phase III clinical trials.Breast cancer research and treatment · 2026Pooled it
- Guidance for Canadian Breast Cancer Practice: National Consensus Recommendations for the Systemic Treatment of Patients with HR+/HER2- Early Breast Cancer 2025.Current oncology (Toronto, Ont.) · 2026Guideline
- [Systemic treatment of breast cancer: professional guideline].Magyar onkologia · 2025Guideline
- 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
- Trial
- Outcomes of Hormone receptor-positive/HER2-negative early breast cancer patients by risk of recurrence groups focusing on the intermediate-risk group: Retrospective analysis from GEICAM studies.Breast cancer research : BCR · 2026Trial
- Neoadjuvant Abemaciclib plus Letrozole Versus Chemotherapy in Patients with HR+/HER2- Highly Proliferative Breast Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026Trial
- Letrozole, abemaciclib and metformin in endometrial cancer: a non-randomized phase 2 trial.Nature communications · 2025Trial
- Palbociclib and endocrine therapy diminish adaptive anti-tumor immunity in early breast cancer: The NeoRHEA phase 2 study.Nature communications · 2025Trial
- Trial
- Impact of adding palbociclib on treatment adherence to ongoing adjuvant endocrine treatment in the global randomized PALLAS randomized trial in patients with early breast cancer.Breast cancer research and treatment · 2025Trial
- An open-label, single-arm, multicenter, phase II trial of bireociclib as monotherapy for heavily pretreated HR-positive, HER2-negative advanced breast cancer patients: BRIGHT-1 trial.Cancer communications (London, England) · 2025Trial
- Health-Related Quality of Life in Patients with HR+/HER2- Early Breast Cancer Treated with Ribociclib Plus a Nonsteroidal Aromatase Inhibitor: Results from the NATALEE Trial.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025Trial
- Metronomic Capecitabine Plus Aromatase Inhibitor as Initial Therapy in Patients With Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer: The Phase III MECCA Trial.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2025Trial
- Evaluating total tumor load (TTL) to predict metastasis in four or more axillary lymph nodes in HR +/HER2- breast cancer patients: the TULIP4N + study.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026Article
- The right patient, the right moment, the right therapy: reimagining precision oncology from the bedside.Cancer metastasis reviews · 2026Review
- Lack of Utility of Ki-67 in Axillary Surgical Planning and Prognostication after Neoadjuvant Chemotherapy for Node-Positive Breast Cancer.Annals of surgical oncology · 2026Article
- A noncanonical function of the tyrosine degradation enzyme FAH drives CDK4/6 inhibitor resistance in breast cancer.Science advances · 2026Article
- Role of Sentinel Node Surgery in Identifying Candidates for Adjuvant CDK4/6 Inhibitors: Implications of Choosing Wisely and ASCO Omission Criteria.Annals of surgical oncology · 2026Article
- Expert consensus on optimal management of liver-related adverse events during CDK4/6 inhibitor therapy.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026Review
518 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
30 authors at 20 institutions in 14 countries.
Funding
Abstract
purposeMany patients with HR+, HER2- early breast cancer (EBC) will not experience recurrence or have distant recurrence with currently available standard therapies. However, up to 30% of patients with high-risk clinical and/or pathologic features may experience distant recurrence, many in the first few years. Superior treatment options are needed to prevent early recurrence and development of metastases for this group of patients. Abemaciclib is an oral, continuously dosed, CDK4/6 inhibitor approved for HR+, HER2- advanced breast cancer (ABC). Efficacy and safety of abemaciclib in ABC supported evaluation in the adjuvant setting.
methodsThis open-label, phase III study included patients with HR+, HER2-, high-risk EBC, who had surgery and, as indicated, radiotherapy and/or adjuvant/neoadjuvant chemotherapy. Patients with four or more positive nodes, or one to three nodes and either tumor size ≥ 5 cm, histologic grade 3, or central Ki-67 ≥ 20%, were eligible and randomly assigned (1:1) to standard-of-care adjuvant endocrine therapy (ET) with or without abemaciclib (150 mg twice daily for 2 years). The primary end point was invasive disease-free survival (IDFS), and secondary end points included distant relapse-free survival, overall survival, and safety.
resultsAt a preplanned efficacy interim analysis, among 5,637 randomly assigned patients, 323 IDFS events were observed in the intent-to-treat population. Abemaciclib plus ET demonstrated superior IDFS versus ET alone (
conclusionAbemaciclib when combined with ET is the first CDK4/6 inhibitor to demonstrate a significant improvement in IDFS in patients with HR+, HER2- node-positive EBC at high risk of early recurrence.
Indexed as
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What OpenQuestion holds
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.