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Abemaciclib + Endocrine Therapy for Breast Cancer (monarchE 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
Able to swallow oral medications
Recovered (grade ≤1) from the acute effects of chemotherapy and radiotherapy and from surgical side effects following definitive breast surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to death from any cause (approximately 10 years)
Awards & highlights

monarchE Trial Summary

This trial is testing a new drug to see if it can effectively treat early stage breast cancer that is hormone receptor positive and human epidermal receptor 2 negative.

Who is the study for?
This trial is for men and women over 18 with high-risk, node-positive, early-stage HR+, HER2- breast cancer. Participants must have a tumor size of at least 5 cm or other high recurrence risk factors, be within 16 months post-surgery, and able to take oral meds. They should not have had certain prior treatments or conditions that could interfere with the study.Check my eligibility
What is being tested?
The trial tests abemaciclib's safety and effectiveness when added to standard endocrine therapy after surgery in patients with specific types of breast cancer. It aims to see if this combination helps reduce the risk of cancer returning more than endocrine therapy alone.See study design
What are the potential side effects?
Abemaciclib may cause diarrhea, fatigue, nausea, decreased appetite, abdominal pain, infections and blood cell count changes. Side effects can vary from person to person.

monarchE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take pills by mouth.
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I have mostly recovered from the side effects of my cancer treatments and surgery.
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I am fully active and can carry on all pre-disease activities without restriction.
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My cancer is aggressive, scoring 8 or more on a specific scale.
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My breast cancer has spread to lymph nodes and shows high risk of coming back due to its size, grade, or growth rate.
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I had my breast cancer surgery less than 16 months ago.
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I am a man or woman aged 18 or older.
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I can have hormone therapy for up to 12 weeks after my last cancer treatment.
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My organs are working well.
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I have had surgery to remove my breast cancer.
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My breast cancer is HR positive, HER2 negative, early stage, and has not spread far.
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I can provide tumor tissue from my breast or lymph node for testing before being assigned to a treatment group.
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My tumor is at least 5 cm in size.

monarchE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to death from any cause (approximately 10 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to death from any cause (approximately 10 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Invasive Disease Free Survival (IDFS)
Secondary outcome measures
Change From Baseline on the EuroQol Five-Dimension Five-Level Questionnaire (EQ-5D-5L)
Change From Baseline on the Functional Assessment of Cancer Therapy - Breast (FACT-B)
Change From Baseline on the Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES)
+5 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%
Neutropenia
18%
White blood cell count decreased
15%
Alopecia
14%
Weight decreased
14%
Dry mouth
14%
Platelet count decreased
14%
Dysgeusia
13%
Dyspnoea
12%
Abdominal pain upper
12%
Back pain
12%
Dizziness
11%
Dyspepsia
11%
Oedema peripheral
11%
Pyrexia
11%
Blood creatinine increased
10%
Pain
9%
Stomatitis
9%
Aspartate aminotransferase increased
8%
Thrombocytopenia
8%
Lacrimation increased
8%
Alanine aminotransferase increased
8%
Dehydration
8%
Dry skin
8%
Pruritus
7%
Upper respiratory tract infection
7%
Urinary tract infection
7%
Flatulence
7%
Hypokalaemia
6%
Chills
6%
Musculoskeletal chest pain
6%
Musculoskeletal pain
6%
Anxiety
5%
Gastrooesophageal reflux disease
5%
Myalgia
5%
Rash
2%
Cellulitis
2%
Pleural effusion
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%
Atypical pneumonia
1%
Gastroenteritis viral
1%
Lung infection
1%
Sepsis
1%
Fall
1%
Hip fracture
1%
Electrocardiogram abnormal
1%
Liver function test abnormal
1%
Renal function test abnormal
1%
Bone pain
1%
Muscular weakness
1%
Acute kidney injury
1%
Pneumonitis
1%
Pneumothorax
1%
Pulmonary embolism
1%
Arterial thrombosis
1%
Epilepsy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Abemaciclib

monarchE Trial Design

2Treatment groups
Experimental Treatment
Group I: Endocrine TherapyExperimental Treatment1 Intervention
Endocrine therapy (physicians' choice) standard-of-care was administered according to package label until discontinuation criteria were met.
Group II: 150 mg Abemaciclib + Endocrine TherapyExperimental Treatment2 Interventions
Participants received Abemaciclib orally at 150 milligrams (mg) twice daily with at least 6 hours between doses for up to 2 years or until evidence of disease recurrence or other discontinuation criteria were met, whichever occurs first. Endocrine therapy (physicians' choice) standard-of-care was administered according to package label until discontinuation criteria were met.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abemaciclib
2019
Completed Phase 2
~1480

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,603 Previous Clinical Trials
3,193,993 Total Patients Enrolled
63 Trials studying Breast Cancer
31,267 Patients Enrolled for Breast Cancer
NSABP Foundation IncNETWORK
86 Previous Clinical Trials
131,351 Total Patients Enrolled
44 Trials studying Breast Cancer
94,893 Patients Enrolled for Breast Cancer
Study DirectorEli Lilly and Company
1,336 Previous Clinical Trials
398,168 Total Patients Enrolled
20 Trials studying Breast Cancer
4,971 Patients Enrolled for Breast Cancer

Media Library

Standard Adjuvant Endocrine Therapy Clinical Trial Eligibility Overview. Trial Name: NCT03155997 — Phase 3
Breast Cancer Research Study Groups: 150 mg Abemaciclib + Endocrine Therapy, Endocrine Therapy
Breast Cancer Clinical Trial 2023: Standard Adjuvant Endocrine Therapy Highlights & Side Effects. Trial Name: NCT03155997 — Phase 3
Standard Adjuvant Endocrine Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT03155997 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Have any other clinical trials been done like this one before?

"Abemaciclib has undergone extensive scrutiny since its inception in 2009. The first study, sponsored by Eli Lilly, included 220 participants. After the first study's successful completion, Abemaciclib received Phase 1 drug approval. As of now, 96 active studies are being conducted in 1273 cities and 41 countries."

Answered by AI

Did the Federal Drug Administration greenlight Abemaciclib for public use?

"Abemaciclib's safety rating is a 3. This is based on the fact that it is a Phase 3 trial, and thus there is both efficacy and safety data available."

Answered by AI

Are there other research studies that have used Abemaciclib?

"Abemaciclib was first researched in 2009. If you wish to learn more about the locations of these clinical trials, you can call the number provided or speak to your personal doctor. There have been a total of 30 completed studies, with 96 more presently ongoing. Some of these trials are based in Springfield, Virginia."

Answered by AI

In how many different locations is this research being conducted today?

"100 patients are being recruited from medical facilities across the country, such as the Willamette Valley Cancer Institute & research Ctr. in Springfield, Hematology Oncology Associates of Fredericksburg Inc. in Fredericksburg, and Virginia Oncology Associates in Norfolk."

Answered by AI

For what type of ailment is Abemaciclib most often recommended by doctors?

"Abemaciclib is typically used to lower the risk of cancer recurrence. However, it can also be used to treat advanced hr + her2 - breast cancer, endocrine therapy, and breast cancer."

Answered by AI

Who else is applying?

What state do they live in?
New York
How old are they?
18 - 65
What site did they apply to?
University Hospitals Case Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
~735 spots leftby Mar 2025