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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
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
MONARCH 3 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.Check my eligibility
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.See study design
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.
MONARCH 3 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active and can carry on all pre-disease activities without restriction.
Select...
My breast cancer is hormone receptor-positive and HER2-negative.
Select...
I've stopped and recovered from radiotherapy aimed at easing symptoms or preventing bone fractures.
Select...
My organs are functioning well.
Select...
My cancer can be measured by tests or is only in my bones.
Select...
I can swallow capsules.
Select...
I have gone through menopause.
Select...
My cancer has returned or spread and cannot be removed or cured with surgery or radiation.
MONARCH 3 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ randomization to progressive disease or death due to any cause (estimated up to 82 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~randomization to progressive disease or death due to any cause (estimated up to 82 months)
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 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 moreSide effects data
From 2018 Phase 2 trial • 132 Patients • NCT0210249091%
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%
Platelet count decreased
14%
Dry mouth
14%
Weight decreased
14%
Dysgeusia
13%
Dyspnoea
12%
Abdominal pain upper
12%
Back pain
12%
Dizziness
11%
Pyrexia
11%
Dyspepsia
11%
Oedema peripheral
11%
Blood creatinine increased
10%
Pain
9%
Stomatitis
9%
Aspartate aminotransferase increased
8%
Dry skin
8%
Thrombocytopenia
8%
Pruritus
8%
Lacrimation increased
8%
Dehydration
8%
Alanine aminotransferase increased
7%
Flatulence
7%
Urinary tract infection
7%
Upper respiratory tract infection
7%
Hypokalaemia
6%
Chills
6%
Musculoskeletal chest pain
6%
Musculoskeletal pain
6%
Anxiety
5%
Rash
5%
Gastrooesophageal reflux disease
5%
Myalgia
2%
Cellulitis
2%
Pleural effusion
1%
Atypical pneumonia
1%
Gastroenteritis viral
1%
Sepsis
1%
Hip fracture
1%
Pneumonitis
1%
Fall
1%
Lung infection
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
MONARCH 3 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
Anastrozole
FDA approved
Letrozole
FDA approved
Abemaciclib
FDA approved
Find a Location
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,613 Previous Clinical Trials
3,200,436 Total Patients Enrolled
63 Trials studying Breast Cancer
36,411 Patients Enrolled for Breast Cancer
Study DirectorEli Lilly and Company
1,344 Previous Clinical Trials
404,759 Total Patients Enrolled
20 Trials studying Breast Cancer
10,115 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active and can carry on all pre-disease activities without restriction.I haven't taken any unapproved drugs within the last 14 or 21 days, depending on the drug type.I started treatment with bisphosphonates or RANK-L inhibitors less than a week ago.I have received hormone therapy for breast cancer that has returned or spread.I've stopped and recovered from radiotherapy aimed at easing symptoms or preventing bone fractures.I have been treated with or been part of a trial for CDK 4/6 inhibitors.My breast cancer is hormone receptor-positive and HER2-negative.My organs are functioning well.I have inflammatory breast cancer.I have been treated with everolimus before.I have or am receiving chemotherapy for advanced breast cancer.I have or had cancer spread to my brain or spinal cord.My cancer can be measured by tests or is only in my bones.I have not had major surgery in the last 14 days.I can swallow capsules.I have gone through menopause.My cancer has spread to my internal organs, lymph system, or brain/spinal cord linings.I had hormone therapy for cancer and my cancer returned within 12 months after finishing treatment.My cancer has returned or spread and cannot be removed or cured with surgery or radiation.
Research Study Groups:
This trial has the following groups:- Group 1: Abemaciclib + NSAI
- Group 2: Placebo + NSAI
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What does the research say about Abemaciclib's efficacy?
"Currently, 265 clinical trials are underway that focus on Abemaciclib. Of these ongoing studies, 60 are in Phase 3. The majority of research for this treatment is based in San Francisco, but there are 18164 locations running related studies."
Answered by AI
What is the primary way that Abemaciclib helps patients?
"Abemaciclib is most commonly used in conjunction with tamoxifen for a period of 2 to 3 years. Additionally, abemaciclib can be given as standalone treatment for patients with early breast cancer or those at high risk for recurrence."
Answered by AI
Are there any unfilled vacancies in this trial for new participants?
"This study does not have any open positions for participants at the moment. The listing was created on November 6th, 2014 and updated most recently on July 21st, 2022. However, there are 2695 other trials concerning breast cancer and 265 studies involving Abemaciclib that are currently recruiting patients."
Answered by AI
What are Abemaciclib's known side effects?
"There is both efficacy and safety data available for Abemaciclib because it has progressed to Phase 3 clinical trials. Therefore, our team gives it a score of 3."
Answered by AI
How many test subjects are needed for this clinical trial to be effective?
"Unfortunately, this particular study is not currently enrolling patients. Although, it's important to note that this study was most recently edited on 7/21/2022 and 2695 other studies are actively recruiting patients with breast cancer. Additionally, there are 265 trials for Abemaciclib seeking participants."
Answered by AI
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