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CDK4/6 Inhibitor

Abemaciclib + Hormone Therapy for Breast Cancer (eMonarcHER 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 received a minimum of four cycles of chemotherapy in either the neoadjuvant or adjuvant setting per standard of care
residual disease in at least one axillary lymph node, or a residual tumor ≥ 5 cm, or a residual tumor of any size that has direct extension to the chest wall and/or skin (ulceration or skin nodules).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up cycle 1 up to end of year 4
Awards & highlights

eMonarcHER Trial Summary

This trial is testing abemaciclib as a treatment for early breast cancer in people who are also taking hormone therapy. It will last up to 10 years.

Who is the study for?
This trial is for individuals with early breast cancer that's HR+ and HER2+, who've had surgery, chemotherapy, and specific HER2-targeted therapy. They should have high-risk disease as defined by the study but no recurrence or distant metastases. Pregnant women, those with other cancers not in remission for 5 years, or a history of blood clots are excluded.Check my eligibility
What is being tested?
The study tests how well Abemaciclib works alongside hormone therapy after surgery in patients with early-stage breast cancer. Participants will either receive Abemaciclib or a placebo in addition to standard hormone therapy over up to a decade based on their response.See study design
What are the potential side effects?
Abemaciclib may cause side effects such as diarrhea, fatigue, low white blood cell counts (increasing infection risk), nausea, abdominal pain, and possibly hair thinning or loss.

eMonarcHER Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have completed at least four rounds of chemotherapy as part of my initial cancer treatment.
Select...
I have remaining cancer in a lymph node, a tumor larger than 5 cm, or a tumor spreading to my chest wall or skin.
Select...
My breast cancer is HR+ and HER2+, without spread beyond the initial site.
Select...
I have had surgery to remove my breast cancer.
Select...
I have a tumor sample from my breast or lymph node.
Select...
I've completed at least four rounds of chemotherapy as part of my initial treatment.

eMonarcHER Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cycle 1 up to end of year 4
This trial's timeline: 3 weeks for screening, Varies for treatment, and cycle 1 up to end of year 4 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Invasive Disease Free Survival (IDFS)
Secondary outcome measures
Change from Baseline in the EuroQOL 5 Dimension 5 Level (EQ-5D 5L) Index Score
Change from Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Scale Score
Distant Relapse-Free Survival (DRFS)
+3 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%
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

eMonarcHER Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Abemaciclib Plus (+) Endocrine Therapy (ET)Experimental Treatment2 Interventions
Abemaciclib administered orally and standard adjuvant ET (physician's choice) administered according to package label.
Group II: Placebo + ETActive Control2 Interventions
Placebo administered orally and standard adjuvant ET (physician's choice) administered according to package label.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abemaciclib
2019
Completed Phase 2
~1710

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,613 Previous Clinical Trials
3,198,479 Total Patients Enrolled
64 Trials studying Breast Cancer
36,904 Patients Enrolled for Breast Cancer
Study DirectorEli Lilly and Company
1,344 Previous Clinical Trials
402,802 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: NCT04752332 — Phase 3
Abemaciclib (CDK4/6 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04752332 — Phase 3
Breast Cancer Research Study Groups: Placebo + ET, Abemaciclib Plus (+) Endocrine Therapy (ET)
Breast Cancer Clinical Trial 2023: Abemaciclib Highlights & Side Effects. Trial Name: NCT04752332 — Phase 3

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 for general use by the FDA?

"Abemaciclib has undergone multiple rounds of testing which supports its safety, giving it a score of 3."

Answered by AI

Abemaciclib is frequently used to manage which type of illness?

"Abemaciclib is a treatment option for patients with an increased risk of cancer recurrence, advanced hormone receptor positive and HER2 negative breast cancer, or who have undergone endocrine therapy."

Answered by AI

In how many different hospitals is this research being conducted?

"Currently, this clinical trial is being conducted by Oncology and Hematology Associates of Southwest Virginia Inc in Salem, Virginia, Highlands Oncology Group in Springdale, Arkansas, Texas Oncology - Dallas Presbyterian Hospital in Greeley, Colorado as well as 100 other locations."

Answered by AI

How many individuals are receiving lenalidomide as part of this research?

"No, this particular study has completed patient recruitment. The trial was first posted on May 10th, 2021 and the most recent update was on November 9th, 2022. However, there are 2369 other trials for breast cancer and 97 studies involving Abemaciclib that are still looking for patients."

Answered by AI

Are we still able to enroll new participants in this research?

"This study isn't enrolling new patients at the moment but was last updated on 11/9/2022. 2369 trials are actively recruiting breast cancer patients and 97 studies are looking for participants that fit the criteria for Abemaciclib."

Answered by AI

What other research exists on this topic?

"Abemaciclib has been researched since 2009 when the first clinical trial completed. Since then, 97 active studies involving Abemaciclib have opened in 1275 cities across 41 countries."

Answered by AI

Are there any other similar medical studies that have been completed with Abemaciclib?

"Abemaciclib was first studied in 2009. If you would like to learn more about the locations where this drug is being investigated, please call 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) and speak to a representative. There have been 18317 completed clinical trials since then, 97 of which are ongoing. A large number of these studies are based out of Salem, Virginia."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Study of Abemaciclib (LY2835219) Plus Hormone Therapy in Participants With Early Breast Cancer
2021. "A Study of Abemaciclib (LY2835219) Plus Hormone Therapy in Participants With Early Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04752332.
All > Breast Cancer High Point > Breast Cancer
~132 spots leftby Jun 2024
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