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CDK4/6 Inhibitor

Abemaciclib + Fulvestrant for Breast Cancer (MONARCH 2 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
For the endocrine naïve cohort: Must not have received prior endocrine therapy in current or prior disease setting
Have either measurable disease or nonmeasurable bone only disease
Must not have
Have received recent yellow fever vaccination
Have active bacterial or fungal infection, or detectable viral infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of randomization until death due to any cause (up to 72 months)
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
Pivotal Trial

Summary

This trial is comparing two treatments for hormone receptor positive, HER2 negative advanced breast cancer. One group will receive abemaciclib + fulvestrant, and the other will just receive fulvestrant. The study will last about 9 months for each participant.

Who is the study for?
This trial is for postmenopausal women with HR+, HER2- advanced breast cancer who haven't had more than one endocrine therapy or any chemo for metastatic disease. They must have a good performance status, no central nervous system metastasis, and not be in another conflicting study.
What is being tested?
The study tests if adding Abemaciclib to Fulvestrant improves progression-free survival compared to Fulvestrant alone in these patients. Participants are randomly assigned to receive either the combination or just Fulvestrant over about 9 months.
What are the potential side effects?
Possible side effects of Abemaciclib may include diarrhea, fatigue, low white blood cell counts (increasing infection risk), nausea, abdominal pain, and possibly increased liver enzymes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have never received hormone therapy for my current or any previous cancer.
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My cancer can be measured by tests or is only in my bones.
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My cancer returned or worsened during or after hormone therapy, or I was initially diagnosed with cancer that had already spread.
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I have not had more than one hormone therapy or any chemotherapy for my advanced cancer.
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My breast cancer is HR+ and HER2-, and cannot be cured with surgery.
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I am postmenopausal due to surgery, natural causes, or medication.
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I am fully active and can carry on all pre-disease activities without restriction.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I recently got a yellow fever vaccine.
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I currently have an active infection (bacterial, fungal, or viral).
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My cancer has spread to my internal organs, lymph system, or brain/spinal cord linings.
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My cancer has spread to my brain or spinal cord.
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I have previously been treated with specific cancer drugs like chemotherapy (not as part of initial treatment), fulvestrant, everolimus, or CDK4/6 inhibitors.
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I have had a stem-cell transplant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of randomization until death due to any cause (up to 72 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of randomization until death due to any cause (up to 72 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 in Health Status Using the EuroQol 5-Dimension 5 Level (EQ-5D 5L)
Change From Baseline in Pain and Symptom Burden Assessment Using the Modified Brief Pain Inventory-Short Form (mBPI-sf)
Change From Baseline to Short Term Follow up in Quality of Life Using the EORTC QLQ-BR23 (Breast) Questionnaire
+7 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 + FulvestrantExperimental Treatment2 Interventions
Abemaciclib 150 milligram (mg) administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered intramuscularly (IM) on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.
Group II: Placebo + FulvestrantPlacebo Group2 Interventions
Placebo administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abemaciclib
FDA approved
Fulvestrant
FDA approved

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,657 Previous Clinical Trials
3,224,221 Total Patients Enrolled
64 Trials studying Breast Cancer
36,697 Patients Enrolled for Breast Cancer
Study DirectorEli Lilly and Company
1,380 Previous Clinical Trials
423,075 Total Patients Enrolled
22 Trials studying Breast Cancer
10,801 Patients Enrolled for Breast Cancer

Media Library

Abemaciclib (CDK4/6 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02107703 — Phase 3
Breast Cancer Research Study Groups: Placebo + Fulvestrant, Abemaciclib + Fulvestrant
Breast Cancer Clinical Trial 2023: Abemaciclib Highlights & Side Effects. Trial Name: NCT02107703 — Phase 3
Abemaciclib (CDK4/6 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02107703 — Phase 3
~59 spots leftby Oct 2025
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