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Cyclin-Dependent Kinase Inhibitor

Aromatase Inhibitors + Abemaciclib for Breast Cancer (MONARCH 3 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 a performance status ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale
Have a diagnosis of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer
Must not have
Have initiated bisphosphonates or approved receptor activator of nuclear factor kappa-B ligand (RANK-L) targeted agents <7 days prior to randomization
Are currently receiving or have previously received endocrine therapy for locoregionally recurrent or metastatic breast cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up randomization to progressive disease or death due to any cause (estimated up to 82 months)
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
Pivotal Trial

Summary

This trial will compare how well two treatments work in postmenopausal women with breast cancer. One treatment group will receive a nonsteroidal aromatase inhibitor plus abemaciclib. The other treatment group will receive a placebo plus abemaciclib.

Who is the study for?
This trial is for postmenopausal women with hormone receptor-positive, HER2-negative breast cancer who can swallow capsules and have either measurable disease or bone-only disease. They should not have received certain prior treatments like everolimus or chemotherapy for advanced breast cancer, nor should they have central nervous system metastasis or be in another conflicting study.
What is being tested?
The effectiveness of nonsteroidal aromatase inhibitors (like Anastrozole and Letrozole) combined with Abemaciclib versus a placebo is being tested. Participants will randomly receive either the drug combination or a placebo at a ratio of 2:1.
What are the potential side effects?
Possible side effects include nausea, fatigue, low blood cell counts leading to increased infection risk, liver issues, diarrhea, hair loss and potential harm to developing fetuses; therefore contraception may be necessary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active and can carry on all pre-disease activities without restriction.
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My breast cancer is hormone receptor-positive and HER2-negative.
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My cancer can be measured by tests or is only in my bones.
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I have gone through menopause.
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My cancer has returned or spread and cannot be removed or cured with surgery or radiation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I started treatment with bisphosphonates or RANK-L inhibitors less than a week ago.
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I have received hormone therapy for breast cancer that has returned or spread.
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I have been treated with or been part of a trial for CDK 4/6 inhibitors.
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I have inflammatory breast cancer.
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I have been treated with everolimus before.
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I have or am receiving chemotherapy for advanced breast cancer.
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I have or had cancer spread to my brain or spinal cord.
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I have not had major surgery in the last 14 days.
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My cancer has spread to my internal organs, lymph system, or brain/spinal cord linings.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~randomization to progressive disease or death due to any cause (estimated up to 82 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and randomization to progressive disease or death due to any cause (estimated up to 82 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression Free Survival (PFS)
Secondary study objectives
Change From Baseline to End of Study in Health Status on the EuroQol-5D 5L Visual Analog Scale (VAS) Scores Scale
Change From Baseline to End of Study in Health Status on the EuroQuol 5-Dimension 5 Level (EuroQol-5D 5L) Index Value
Change From Baseline to End of Study in Symptom Burden on the EORTC QLQ-Breast23 Questionnaire
+9 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

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Abemaciclib + NSAIExperimental Treatment3 Interventions
150 milligrams (mg) Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
Group II: Placebo + NSAIPlacebo Group3 Interventions
Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abemaciclib
FDA approved
Anastrozole
FDA approved
Letrozole
FDA approved

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,667 Previous Clinical Trials
3,227,984 Total Patients Enrolled
63 Trials studying Breast Cancer
36,204 Patients Enrolled for Breast Cancer
Study DirectorEli Lilly and Company
1,383 Previous Clinical Trials
425,648 Total Patients Enrolled
21 Trials studying Breast Cancer
10,308 Patients Enrolled for Breast Cancer

Media Library

Abemaciclib (Cyclin-Dependent Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02246621 — Phase 3
Breast Cancer Research Study Groups: Abemaciclib + NSAI, Placebo + NSAI
Breast Cancer Clinical Trial 2023: Abemaciclib Highlights & Side Effects. Trial Name: NCT02246621 — Phase 3
Abemaciclib (Cyclin-Dependent Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02246621 — Phase 3
~45 spots leftby Nov 2025
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