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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 a negative serum pregnancy test at baseline and agree to use medically approved precautions to prevent pregnancy during the study and for 12 weeks following the last dose of abemaciclib if postmenopausal status is due to ovarian suppression with a GnRH agonist
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of randomization until death due to any cause (up to 72 months)
Awards & highlights

MONARCH 2 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.Check my eligibility
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.See study design
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.

MONARCH 2 Trial 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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I am not pregnant and agree to use birth control during and 12 weeks after the study if my menopause is due to treatment.
Select...
My cancer can be measured by tests or is only in my bones.
Select...
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.
Select...
My breast cancer is HR+ and HER2-, and cannot be cured with surgery.
Select...
I am postmenopausal due to surgery, natural causes, or medication.
Select...
I am fully active and can carry on all pre-disease activities without restriction.
Select...
I have stopped my previous cancer treatments and recovered from their immediate side effects.

MONARCH 2 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-Free Survival (PFS)
Secondary outcome measures
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%
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

MONARCH 2 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
2,603 Previous Clinical Trials
3,198,961 Total Patients Enrolled
64 Trials studying Breast Cancer
36,904 Patients Enrolled for Breast Cancer
Study DirectorEli Lilly and Company
1,336 Previous Clinical Trials
403,136 Total Patients Enrolled
21 Trials studying Breast Cancer
10,608 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

Frequently Asked Questions

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

What is the largest amount of people that are allowed to enroll in this test?

"This trial is no longer recruiting patients. It was posted on July 22nd, 2014 and last edited on November 15th, 2022. For other trials, there are 2369 studies for breast cancer and 216 for Abemaciclib that are currently admitting patients."

Answered by AI

Has Abemaciclib undergone regulatory approval by the FDA?

"Abemaciclib is a safe medication, as there is both efficacy and safety data supporting its use in Phase 3 clinical trials."

Answered by AI

What is the standard indication for Abemaciclib?

"The pik3ca gene mutation is most often treated using Abemaciclib. This medication can also be effective at treating other conditions, such as advanced hr+ her2- breast cancer, malignant neoplasms, and disease progression."

Answered by AI

Are there any volunteers currently needed for this research project?

"As of right now, this study is not looking for new patients. According to the information on clinicaltrials.gov, which was last updated on November 15th, 2022, the trial was first posted on July 22nd, 2014. If you are interested in other trials, there are currently 2369 active studies related to breast cancer and 216 studies involving Abemaciclib that are actively recruiting participants."

Answered by AI

What does the research say about Abemaciclib?

"Abemaciclib was first studied in 2004 at Lowell General Hospital. As of now, a total of 18399 completed studies exist. Currently, there are 216 actively recruiting trials taking place--many of which are based out of Aurora, Colorado."

Answered by AI

In how many different areas is this clinical trial taking place?

"There are 55 sites running this trial currently. Some notable locations include Aurora, Winston-Salem and Tulsa. To cut down on how much you may need to travel, it is best to select the clinic nearest you."

Answered by AI
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~63 spots leftby Mar 2025