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CDK4/6 Inhibitor
Abemaciclib + Fulvestrant for Breast Cancer (postMONARCH 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
If female, have a postmenopausal status by natural or surgical means or by ovarian function suppression
Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group scale (Oken et al. 1982)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up randomization until death from any cause (estimated as up to 5 years)
Awards & highlights
postMONARCH Trial Summary
This trial will study adding abemaciclib to fulvestrant for treating HR+, HER2- breast cancer that progressed or recurred after previous CDK4/6 inhibitor and endocrine therapy.
Who is the study for?
This trial is for postmenopausal women with HR+, HER2- advanced or metastatic breast cancer that worsened after treatment with CDK4/6 inhibitors and endocrine therapy. They must have good organ function, measurable disease progression, be able to take oral medication, and have a performance status of 0 or 1. Women who've had chemotherapy for metastatic breast cancer or certain other treatments are excluded.Check my eligibility
What is being tested?
The study tests if adding abemaciclib to fulvestrant improves outcomes in patients whose breast cancer progressed after previous therapies. Participants will either receive the combination of abemaciclib plus fulvestrant or a placebo plus fulvestrant over up to five years, depending on their response.See study design
What are the potential side effects?
Abemaciclib may cause diarrhea, fatigue, nausea, decreased appetite and blood cell counts leading to infection risk; it can also affect liver enzymes. Fulvestrant's side effects include injection site pain, general weakness and elevated liver enzymes.
postMONARCH Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am postmenopausal.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My cancer has grown or come back, shown by scans.
Select...
My breast cancer is HR+ and HER2-, and it has spread.
Select...
I can swallow pills.
Select...
I am currently being treated with a CDK4/6 inhibitor and aromatase inhibitor for advanced breast cancer.
postMONARCH Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ randomization until death from any cause (estimated as up to 5 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~randomization until death from any cause (estimated as up to 5 years)
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
Clinical Benefit Rate (CBR): Percentage of Participants Who Achieve a Best Overall Response of CR, PR or Stable Disease for Greater than or Equal to (≥) 24 Weeks
Disease Control Rate (DCR): Percentage of Participants with a Best Overall Response of CR, PR, and stable disease (SD)
Duration of Response (DoR)
+6 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
postMONARCH Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A: Abemaciclib plus FulvestrantExperimental Treatment2 Interventions
Abemaciclib administered orally in combination with fulvestrant administered intramuscularly (IM).
Group II: Arm B: Placebo plus FulvestrantActive Control2 Interventions
Placebo administered orally in combination with fulvestrant administered IM.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abemaciclib
2019
Completed Phase 2
~1710
Fulvestrant
2011
Completed Phase 3
~3690
Find a Location
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,613 Previous Clinical Trials
3,200,561 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,344 Previous Clinical Trials
404,884 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have undergone multiple treatments for my advanced or metastatic disease.I have previously been treated with specific hormone or targeted therapies for my cancer.I have brain metastases that are causing symptoms or have not been treated.I am postmenopausal.I have had treatment for my cancer after it came back or got worse before joining this study.I am fully active or restricted in physically strenuous activity but can do light work.I have had chemotherapy for breast cancer that has spread.My kidney, blood, and liver functions are all within normal ranges.My cancer has grown or come back, shown by scans.Your disease can be measured and evaluated using specific criteria for solid tumors.My breast cancer is HR+ and HER2-, and it has spread.My cancer has spread to my internal organs, lymph system, or brain/spinal cord linings.My doctor thinks ET is a suitable treatment for me.I can swallow pills.I am currently being treated with a CDK4/6 inhibitor and aromatase inhibitor for advanced breast cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A: Abemaciclib plus Fulvestrant
- Group 2: Arm B: Placebo plus Fulvestrant
Awards:
This trial has 1 awards, including:- 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.
Has Abemaciclib been cleared by the FDA?
"Abemaciclib received a safety score of 3 because it is a Phase 3 trial, which means that while the medication's efficacy has yet to be proven, there is data supporting its safety."
Answered by AI
Are there different research facilities studying this topic?
"As of now, this study is taking patients from Sarah Cannon Research Institute SCRI in Chattanooga, Tennessee, Dana-Farber Cancer Institute in South Weymouth, Massachusetts, and Quincy Medical Group in Quincy, Illinois. However, there are 72 other locations that may be added in the future."
Answered by AI
What medical condition is Abemaciclib most commonly used to treat?
"Abemaciclib is a common treatment for patients with the pik3ca gene mutation. However, it can also help those suffering from advanced hr + her2 - breast cancer, malignant neoplasms, and progression, disease."
Answered by AI
Can you tell me if Abemaciclib has been used in any other research projects?
"As of right now, there are a whopping 216 clinical trials researching abemaciclib. That's a lot of data! Out of those active studies, 42 have reached Phase 3. The majority of the research is based in Alicante and Pamplona/Iruña, but 9840 locations around the world are running clinical trials for this treatment."
Answered by AI
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