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Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer

NCT03155997 · monarchE Phase 3Active, not recruiting

Lead sponsor
Eli Lilly and Company (Industry)
Enrollment
5,637 (actual)
Start date
12 Jul 2017
Primary completion
16 Mar 2020 (actual)
Study completion
1 May 2029
Last update posted
24 Apr 2026

Design

Study type
Interventional
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel
Masking
None
Arms
2

Interventions

  • Abemaciclib Drug
  • Standard Adjuvant Endocrine Therapy Drug

Conditions and primary outcome

  • Breast Cancer

Primary outcome

Invasive Disease Free Survival (IDFS) (Baseline to Recurrence or Death from Any Cause (Up to 32 Months))

Posted results on ClinicalTrials.gov

Source: ClinicalTrials.gov results for NCT03155997 (opens in a new tab)· Licence: public-domain

First posted · Last update posted · Imported from ClinicalTrials.gov download 2026-10-25

Primary outcomes with a statistical analysis

  1. Invasive Disease Free Survival (IDFS)

    Time frame
    Baseline to Recurrence or Death from Any Cause (Up to 32 Months)
    Measure
    Median
    Unit
    Months

    • 150 mg Abemaciclib + Endocrine Therapy vs Endocrine TherapySuperiority

      Estimate
      0.747Hazard Ratio (HR)
      95% CI, two-sided
      0.598 to 0.932
      p-value
      0.00957
      Method
      Log Rank

Serious adverse events

Time frame: Baseline to 32 Months

Participants with serious adverse events per group for monarchE, as posted
GroupAffectedAt risk
150 mg Abemaciclib + Endocrine Therapy3442791
Endocrine Therapy2022800

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

Results from company and journal sources

No editor-confirmed results are on record for this study.

Publications

13 on PubMed

  1. Overall survival with abemaciclib in early breast cancer.

    Annals of oncology : official journal of the European Society for Medical Oncology · 2026 Feb

    PubMed 41110697 (opens in a new tab)DOI 10.1016/j.annonc.2025.10.005 (opens in a new tab)

  2. Abemaciclib combined with endocrine therapy as adjuvant treatment for hormone-receptor-positive, HER2-, high-risk early breast cancer: 5-year Chinese population analysis of the phase III randomized monarchE study.

    Therapeutic advances in medical oncology · 2024

    PubMed 39463748 (opens in a new tab)DOI 10.1177/17588359241286775 (opens in a new tab)

  3. Adjuvant Abemaciclib Plus Endocrine Therapy for Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative, High-Risk Early Breast Cancer: Results From a Preplanned monarchE Overall Survival Interim Analysis, Including 5-Year Efficacy Outcomes.

    Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024 Mar 20

    PubMed 38194616 (opens in a new tab)DOI 10.1200/JCO.23.01994 (opens in a new tab)

  4. Abemaciclib as adjuvant treatment for high-risk early breast cancer.

    Farmacia hospitalaria : organo oficial de expresion cientifica de la Sociedad Espanola de Farmacia Hospitalaria · 2024 Mar-Apr

    PubMed 37735004 (opens in a new tab)DOI 10.1016/j.farma.2023.08.006 (opens in a new tab)

  5. Abemaciclib plus endocrine therapy for HR+, HER2-, node-positive, high-risk early breast cancer: a plain language summary of the monarchE study.

    Future oncology (London, England) · 2024

    PubMed 39023253 (opens in a new tab)DOI 10.1080/14796694.2024.2362095 (opens in a new tab)

  6. Adjuvant Abemaciclib Combined with Endocrine Therapy: Efficacy Results in monarchE Cohort 1.

    The oncologist · 2023 Jan 18

    PubMed 36342342 (opens in a new tab)DOI 10.1093/oncolo/oyac234 (opens in a new tab)

  7. Abemaciclib plus endocrine therapy for hormone receptor-positive, HER2-negative, node-positive, high-risk early breast cancer (monarchE): results from a preplanned interim analysis of a randomised, open-label, phase 3 trial.

    The Lancet. Oncology · 2023 Jan

    PubMed 36493792 (opens in a new tab)DOI 10.1016/S1470-2045(22)00694-5 (opens in a new tab)

  8. Treatment With Adjuvant Abemaciclib Plus Endocrine Therapy in Patients With High-risk Early Breast Cancer Who Received Neoadjuvant Chemotherapy: A Prespecified Analysis of the monarchE Randomized Clinical Trial.

    JAMA oncology · 2022 Aug 1

    PubMed 35653145 (opens in a new tab)DOI 10.1001/jamaoncol.2022.1488 (opens in a new tab)

  9. Adjuvant abemaciclib combined with endocrine therapy for high-risk early breast cancer: safety and patient-reported outcomes from the monarchE study.

    Annals of oncology : official journal of the European Society for Medical Oncology · 2022 Jun

    PubMed 35337972 (opens in a new tab)DOI 10.1016/j.annonc.2022.03.006 (opens in a new tab)

  10. Update on Pregnancy Following Breast Cancer Diagnosis and Treatment.

    Cancer journal (Sudbury, Mass.) · 2022 May-Jun 01

    PubMed 35594464 (opens in a new tab)DOI 10.1097/PPO.0000000000000599 (opens in a new tab)

  11. FDA Approval Summary: Abemaciclib With Endocrine Therapy for High-Risk Early Breast Cancer.

    Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2022 Apr 10

    PubMed 35084948 (opens in a new tab)DOI 10.1200/JCO.21.02742 (opens in a new tab)

  12. A Standardized Investigational Ki-67 Immunohistochemistry Assay Used to Assess High-Risk Early Breast Cancer Patients in the monarchE Phase 3 Clinical Study Identifies a Population With Greater Risk of Disease Recurrence When Treated With Endocrine Therapy Alone.

    Applied immunohistochemistry & molecular morphology : AIMM · 2022 Apr 1

    PubMed 35384873 (opens in a new tab)DOI 10.1097/PAI.0000000000001009 (opens in a new tab)

  13. Abemaciclib Combined With Endocrine Therapy for the Adjuvant Treatment of HR+, HER2-, Node-Positive, High-Risk, Early Breast Cancer (monarchE).

    Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2020 Dec 1

    PubMed 32954927 (opens in a new tab)DOI 10.1200/JCO.20.02514 (opens in a new tab)

Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.

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Data integrity

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Source

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

Nothing on this page is medical or investment advice.