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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 either measurable disease or nonmeasurable bone only disease

Must not have

Have received recent yellow fever vaccination

Have active bacterial or fungal infection, or detectable viral infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of randomization until death due to any cause (up to 72 months)

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

Pivotal 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.

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.

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.

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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My cancer can be measured by tests or is only in my bones.

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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.

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My breast cancer is HR+ and HER2-, and cannot be cured with surgery.

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I am postmenopausal due to surgery, natural causes, or medication.

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

Exclusion Criteria

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

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I recently got a yellow fever vaccine.

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I currently have an active infection (bacterial, fungal, or viral).

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My cancer has spread to my internal organs, lymph system, or brain/spinal cord linings.

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My cancer has spread to my brain or spinal cord.

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I have previously been treated with specific cancer drugs like chemotherapy (not as part of initial treatment), fulvestrant, everolimus, or CDK4/6 inhibitors.

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I have had a stem-cell transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of randomization until death due to any cause (up to 72 months)

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

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

Primary study objectives

Progression-Free Survival (PFS)

Secondary study objectives

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%

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

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.

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

0 / 13Eligibility criteria met