← Back to Search

Abemaciclib + Endocrine Therapy for Breast Cancer (monarchE 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

Able to swallow oral medications

Eastern Cooperative Oncology Group (ECOG) performance status ≤1

Must not have

Metastatic disease (including contralateral axillary lymph nodes) or node-negative disease

Receiving concurrent exogenous reproductive hormone therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to death from any cause (approximately 10 years)

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial is testing a new drug to see if it can effectively treat early stage breast cancer that is hormone receptor positive and human epidermal receptor 2 negative.

Who is the study for?

This trial is for men and women over 18 with high-risk, node-positive, early-stage HR+, HER2- breast cancer. Participants must have a tumor size of at least 5 cm or other high recurrence risk factors, be within 16 months post-surgery, and able to take oral meds. They should not have had certain prior treatments or conditions that could interfere with the study.

What is being tested?

The trial tests abemaciclib's safety and effectiveness when added to standard endocrine therapy after surgery in patients with specific types of breast cancer. It aims to see if this combination helps reduce the risk of cancer returning more than endocrine therapy alone.

What are the potential side effects?

Abemaciclib may cause diarrhea, fatigue, nausea, decreased appetite, abdominal pain, infections and blood cell count changes. Side effects can vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can take pills by mouth.

Select...

I am fully active and can carry on all pre-disease activities without restriction.

Select...

My cancer is aggressive, scoring 8 or more on a specific scale.

Select...

My breast cancer has spread to lymph nodes and shows high risk of coming back due to its size, grade, or growth rate.

Select...

I have had surgery to remove my breast cancer.

Select...

My breast cancer is HR positive, HER2 negative, early stage, and has not spread far.

Select...

My tumor is at least 5 cm in size.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My cancer has spread to distant areas or is present without lymph node involvement.

Select...

I am currently on hormone therapy for reproductive reasons.

Select...

I do not have any active infections or high viral loads.

Select...

I have been treated with CDK4/6 inhibitors before.

Select...

I have taken medication (like tamoxifen) for breast cancer prevention.

Select...

I have inflammatory breast cancer.

Select...

I have a history of fainting due to heart issues, abnormal heart rhythms, or sudden cardiac arrest. I also have a history of blood clots in my veins.

Select...

I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to death from any cause (approximately 10 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to death from any cause (approximately 10 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to death from any cause (approximately 10 years) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Invasive Disease Free Survival (IDFS)

Secondary study objectives

Change From Baseline on the EuroQol Five-Dimension Five-Level Questionnaire (EQ-5D-5L)

Change From Baseline on the Functional Assessment of Cancer Therapy - Breast (FACT-B)

Change From Baseline on the Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES)

+5 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

Stomatitis

Aspartate aminotransferase increased

Thrombocytopenia

Lacrimation increased

Dehydration

Dry skin

Pruritus

Alanine aminotransferase increased

Flatulence

Upper respiratory tract infection

Urinary tract infection

Hypokalaemia

Chills

Musculoskeletal chest pain

Musculoskeletal pain

Anxiety

Gastrooesophageal reflux disease

Rash

Myalgia

Cellulitis

Pleural effusion

Atypical pneumonia

Gastroenteritis viral

Lung infection

Sepsis

Fall

Hip fracture

Pneumonitis

Pneumothorax

Febrile neutropenia

Respiratory tract infection

Haematotoxicity

Sinus bradycardia

Tachycardia

Large intestinal obstruction

Pancreatic enzyme abnormality

Pancreatitis

Varices oesophageal

Electrocardiogram abnormal

Liver function test abnormal

Renal function test abnormal

Bone pain

Muscular weakness

Acute kidney injury

Pulmonary embolism

Arterial thrombosis

Epilepsy

100%

80%

60%

40%

20%

Study treatment Arm

Abemaciclib

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Endocrine TherapyExperimental Treatment1 Intervention

Endocrine therapy (physicians' choice) standard-of-care was administered according to package label until discontinuation criteria were met.

Group II: 150 mg Abemaciclib + Endocrine TherapyExperimental Treatment2 Interventions

Participants received Abemaciclib orally at 150 milligrams (mg) twice daily with at least 6 hours between doses for up to 2 years or until evidence of disease recurrence or other discontinuation criteria were met, whichever occurs first. Endocrine therapy (physicians' choice) standard-of-care was administered according to package label until discontinuation criteria were met.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Abemaciclib

2019

Completed Phase 2

~1890

0 / 15Eligibility criteria met