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CDK4/6 Inhibitor

Abemaciclib + Hormone Therapy for Breast Cancer (eMonarcHER Trial)

Phase 3
Waitlist Available
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have received a minimum of four cycles of chemotherapy in either the neoadjuvant or adjuvant setting per standard of care
residual disease in at least one axillary lymph node, or a residual tumor ≥ 5 cm, or a residual tumor of any size that has direct extension to the chest wall and/or skin (ulceration or skin nodules).
Must not have
Breast cancer with disease recurrence or distant metastatic disease
Pathological complete response from any prior early breast cancer treatments
Timeline
Screening 3 weeks
Treatment Varies
Follow Up cycle 1 up to end of year 4
Awards & highlights
Pivotal Trial

Summary

This trial is testing abemaciclib as a treatment for early breast cancer in people who are also taking hormone therapy. It will last up to 10 years.

Who is the study for?
This trial is for individuals with early breast cancer that's HR+ and HER2+, who've had surgery, chemotherapy, and specific HER2-targeted therapy. They should have high-risk disease as defined by the study but no recurrence or distant metastases. Pregnant women, those with other cancers not in remission for 5 years, or a history of blood clots are excluded.
What is being tested?
The study tests how well Abemaciclib works alongside hormone therapy after surgery in patients with early-stage breast cancer. Participants will either receive Abemaciclib or a placebo in addition to standard hormone therapy over up to a decade based on their response.
What are the potential side effects?
Abemaciclib may cause side effects such as diarrhea, fatigue, low white blood cell counts (increasing infection risk), nausea, abdominal pain, and possibly hair thinning or loss.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have completed at least four rounds of chemotherapy as part of my initial cancer treatment.
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I have remaining cancer in a lymph node, a tumor larger than 5 cm, or a tumor spreading to my chest wall or skin.
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My breast cancer is HR+ and HER2+, without spread beyond the initial site.
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I have had surgery to remove my breast cancer.
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I have a tumor sample from my breast or lymph node.
Select...
I've completed at least four rounds of chemotherapy as part of my initial treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My breast cancer has returned or spread to other parts of my body.
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My early breast cancer treatment was completely successful.
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I have inflammatory breast cancer.
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I am not on extra cancer treatments beyond what's standard at study start.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cycle 1 up to end of year 4
This trial's timeline: 3 weeks for screening, Varies for treatment, and cycle 1 up to end of year 4 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Invasive Disease Free Survival (IDFS)
Secondary study objectives
Change from Baseline in the EuroQOL 5 Dimension 5 Level (EQ-5D 5L) Index Score
Change from Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Scale Score
Distant Relapse-Free Survival (DRFS)
+3 more

Side effects data

From 2018 Phase 2 trial • 132 Patients • NCT02102490
91%
Diarrhoea
67%
Nausea
48%
Fatigue
45%
Decreased appetite
35%
Vomiting
27%
Anaemia
26%
Abdominal pain
23%
Asthenia
23%
Neutrophil count decreased
21%
Cough
20%
Constipation
20%
Headache
19%
Arthralgia
18%
White blood cell count decreased
18%
Neutropenia
15%
Alopecia
14%
Dry mouth
14%
Platelet count decreased
14%
Weight decreased
14%
Dysgeusia
13%
Dyspnoea
12%
Abdominal pain upper
12%
Back pain
12%
Dizziness
11%
Oedema peripheral
11%
Dyspepsia
11%
Pyrexia
11%
Blood creatinine increased
10%
Pain
9%
Stomatitis
9%
Aspartate aminotransferase increased
8%
Thrombocytopenia
8%
Lacrimation increased
8%
Dehydration
8%
Dry skin
8%
Pruritus
8%
Alanine aminotransferase increased
7%
Flatulence
7%
Upper respiratory tract infection
7%
Urinary tract infection
7%
Hypokalaemia
6%
Chills
6%
Musculoskeletal chest pain
6%
Musculoskeletal pain
6%
Anxiety
5%
Gastrooesophageal reflux disease
5%
Rash
5%
Myalgia
2%
Cellulitis
2%
Pleural effusion
1%
Atypical pneumonia
1%
Gastroenteritis viral
1%
Lung infection
1%
Sepsis
1%
Fall
1%
Hip fracture
1%
Pneumonitis
1%
Pneumothorax
1%
Febrile neutropenia
1%
Respiratory tract infection
1%
Haematotoxicity
1%
Sinus bradycardia
1%
Tachycardia
1%
Large intestinal obstruction
1%
Pancreatic enzyme abnormality
1%
Pancreatitis
1%
Varices oesophageal
1%
Electrocardiogram abnormal
1%
Liver function test abnormal
1%
Renal function test abnormal
1%
Bone pain
1%
Muscular weakness
1%
Acute kidney injury
1%
Pulmonary embolism
1%
Arterial thrombosis
1%
Epilepsy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Abemaciclib

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Abemaciclib Plus (+) Endocrine Therapy (ET)Experimental Treatment2 Interventions
Abemaciclib administered orally and standard adjuvant ET (physician's choice) administered according to package label.
Group II: Placebo + ETActive Control2 Interventions
Placebo administered orally and standard adjuvant ET (physician's choice) administered according to package label.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abemaciclib
2019
Completed Phase 2
~1890

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,672 Previous Clinical Trials
3,463,682 Total Patients Enrolled
65 Trials studying Breast Cancer
36,728 Patients Enrolled for Breast Cancer
Study DirectorEli Lilly and Company
1,386 Previous Clinical Trials
426,587 Total Patients Enrolled
22 Trials studying Breast Cancer
10,804 Patients Enrolled for Breast Cancer

Media Library

Abemaciclib (CDK4/6 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04752332 — Phase 3
Abemaciclib (CDK4/6 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04752332 — Phase 3
Breast Cancer Research Study Groups: Placebo + ET, Abemaciclib Plus (+) Endocrine Therapy (ET)
Breast Cancer Clinical Trial 2023: Abemaciclib Highlights & Side Effects. Trial Name: NCT04752332 — Phase 3
~25 spots leftby Nov 2025
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