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NCT04752332: eMonarcHER
A Study of Abemaciclib (LY2835219) Plus Hormone Therapy in Participants With Early Breast Cancer
Phase 3 trial testing Abemaciclib in Breast Neoplasms in 111 participants. Terminated before completion.
26 June 2024
Quick facts
| Lead sponsor | Eli Lilly and Company |
|---|---|
| Phase | Phase 3 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 111 |
| Start date | 10 May 2021 |
| Primary completion | 26 June 2024 |
| Estimated completion | 26 June 2024 |
| Sites | 115 locations across Italy, Japan, Taiwan, South Korea, Belgium, Mexico, United States, France |
Drugs / interventions tested
- Abemaciclib (abemaciclib) — full drug profile →
- Standard Adjuvant ET — full drug profile →
- Placebo
Conditions studied
- Breast Neoplasms — all drugs for Breast Neoplasms →
Sponsor
Eli Lilly and Company — full company profile →
Who can join
18 and older, any sex, with Breast Neoplasms. Patients with the condition only — healthy volunteers not accepted.
Adverse events — posted to ClinicalTrials.gov
Time frame: Baseline Up To 890 Days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Serious adverse events (7 terms)
| Reaction | System | 150 mg Abemaciclib + ET | Placebo + ET |
|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | — | — |
| Anal abscess | Infections and infestations | — | — |
| Covid-19 | Infections and infestations | — | — |
| Radius fracture | Injury, poisoning and procedural complications | — | — |
| Alanine aminotransferase increased | Investigations | — | — |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | — | — |
Other adverse events (34 terms — click to expand)
| Reaction | System | 150 mg Abemaciclib + ET | Placebo + ET |
|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | — | — |
| Neutropenia | Blood and lymphatic system disorders | — | — |
| Leukopenia | Blood and lymphatic system disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Fatigue | General disorders | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — |
| Covid-19 | Infections and infestations | — | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — |
| Blood creatinine increased | Investigations | — | — |
| Hot flush | Vascular disorders | — | — |
| Dizziness | Nervous system disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Pruritus | Skin and subcutaneous tissue disorders | — | — |
| Lymphopenia | Blood and lymphatic system disorders | — | — |
| Stomatitis | Gastrointestinal disorders | — | — |
| Pyrexia | General disorders | — | — |
| Nasopharyngitis | Infections and infestations | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Palpitations | Cardiac disorders | — | — |
| Abdominal distension | Gastrointestinal disorders | — | — |
| Oedema peripheral | General disorders | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — |
| Urinary tract infection | Infections and infestations | — | — |
| Alanine aminotransferase increased | Investigations | — | — |
| Aspartate aminotransferase increased | Investigations | — | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — |
Most-reported serious reactions: Neutropenia, Anal abscess, Covid-19, Radius fracture, Alanine aminotransferase increased, Uterine leiomyoma, Pulmonary embolism.
Data from ClinicalTrials.gov NCT04752332 adverse events section.
Sponsor's own description
The main purpose of this study is to measure how well abemaciclib works in participants with early breast cancer who are taking hormone therapy after surgery. Participants must have breast cancer that is hormone receptor positive (HR+) and human epidermal receptor 2 positive (HER2+). Your participation could last up to 10 years depending on how you and your tumor respond.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Adjuvant Targeted Therapy in Solid Cancers: Pioneers and New Glories.
Sposito M, Belluomini L, Pontolillo L, Tregnago D, et al · · 2023 · cited 5× · PMID 37888038 · DOI 10.3390/jpm13101427 -
The Role of PIM Kinases in Pediatric Solid Tumors.
Julson JR, Marayati R, Beierle EA, Stafman LL. · · 2022 · cited 5× · PMID 35892829 · DOI 10.3390/cancers14153565 -
Role of abemaciclib in primary breast cancer: a narrative review of MonarchE.
Takahashi N, Shimizu C, Shimomura A, Toi M. · · 2022 · PMID 38751527 · DOI 10.21037/tbcr-21-27
Verify or expand the search:
- PubMed search for NCT04752332
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Abemaciclib
Trials testing the same drug.
- NCT07492641 — BGB-43395 Plus Letrozole Versus CDK4/6i Plus Letrozole for Patients With Advanced or Metastatic HR+/HER2- Breast Cancer · Phase 3 · not yet recruiting
- NCT07428018 — Pragmatic Study to Optimize Neoadjuvant Treatment and Surgical De-escalation in HR+/HER2- Early Breast Cancer Using Onco · Phase 2 · not yet recruiting
- NCT07191717 — Imlunestrant and Abemaciclib for the Treatment of Estrogen Receptor Positive Breast Cancer in Patients With Minimal Resi · Phase 2 · not yet recruiting
- NCT06498648 — Testing the Addition of an Anti-cancer Drug, Abemaciclib, to the Usual Chemotherapy Treatment (Gemcitabine) for Soft Tis · Phase 1, PHASE2 · recruiting
- NCT07441369 — Abemaciclib Combined With FOLFOX/FOLFIRI Regimen in Patients With Advanced Colorectal Liver Metastases Cancer · Phase 2 · enrolling by invitation
Other recruiting trials for Breast Neoplasms
Currently open trials in the same condition.
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- NCT07500428 — Construction of a Benchmark for Breast Ultrasound AI Interpretation and Performance Evaluation of Multimodal AI Models · recruiting
- NCT07581834 — Efficacy and Safety of Dalpiciclib Combined With Endocrine Adjuvant Therapy for Early HR +/HER2- Breast Cancer: a Multic · Phase 2 · recruiting
- NCT07222215 — PhII Randomized CAPecitabine + ELAcestrant vs. Capecitabine Alone in ER+ Breast Cancer (CAPELA) · Phase 2 · recruiting
- NCT07465393 — Facility-Based Multi-Modal Rehab vs. Home-Based Resistance Exercise for Quality of Life in Breast Cancer Survivors · NA · recruiting
Other Eli Lilly and Company trials
Trials by the same sponsor.
- NCT07533006 — A Study of LY4005130 in Adult Participants With Severe Alopecia Areata (Hair Loss) · Phase 2 · not yet recruiting
- NCT07533019 — A Study of LY4005130 in Adult Participants With Non-Segmental Vitiligo · Phase 2 · not yet recruiting
- NCT07247357 — A Study of LY4064809 in Healthy Adult Chinese Participants · Phase 1 · completed
- NCT07124013 — A Study of Olomorasib (LY3537982) in Healthy Japanese Participants · Phase 1 · completed
- NCT07030127 — A Study of LY3985863 in Healthy Participants · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04752332 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Eli Lilly and Company
- Last refreshed: 15 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04752332.
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