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CDK4/6 Inhibitor

Abemaciclib + Trastuzumab for Breast Cancer (monarcHER Trial)

Phase 2

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

Adequate tumor tissue available prior to randomization

Diagnosis of HR+, HER2+ breast cancer (BC) that is unresectable locally advanced recurrent BC or metastatic BC

Timeline

Screening 3 weeks

Treatment Varies

Follow Up date of cr, pr or sd to 6 months post cr, pr or sd (up to 36 months)

Awards & highlights

monarcHER Trial Summary

This trial will compare abemaciclib+trastuzumab with or without fulvestrant to trastuzumab+ standard of care chemotherapy in women with HR+, HER2+ breast cancer.

Who is the study for?

This trial is for women with HR+, HER2+ advanced or metastatic breast cancer who've had at least two prior HER2-targeted treatments. They must have good organ function, not be pregnant, and agree to contraception. Exclusions include recent heart issues, untreated brain metastases, major surgery within 14 days, certain infections or allergies to study drugs.Check my eligibility

What is being tested?

The study tests the effectiveness of abemaciclib combined with trastuzumab and possibly fulvestrant against standard chemotherapy plus trastuzumab in patients previously treated for advanced breast cancer. It aims to see if this new combination can better control the disease.See study design

What are the potential side effects?

Potential side effects may include diarrhea, fatigue, low white blood cell counts (increasing infection risk), nausea, liver enzyme changes suggesting liver injury, deep vein thrombosis or pulmonary embolism (blood clots), and potential harm to a fetus.

monarcHER Trial Eligibility Criteria

Inclusion Criteria

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

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I have enough tumor tissue available for testing.

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I have HR+ and HER2+ breast cancer that cannot be surgically removed or has spread.

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I have had at least 2 treatments targeting HER2 for my advanced cancer.

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I have been treated with trastuzumab emtansine (T-DM1) before.

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

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I am fully active or restricted in physically strenuous activity but can do light work.

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I stopped all cancer treatments except trastuzumab 3 weeks ago for strong drugs or 2 weeks for others, and have recovered from side effects.

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I have been treated with a taxane medication before.

monarcHER Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ date of cr, pr or sd to 6 months post cr, pr or sd (up to 36 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~date of cr, pr or sd to 6 months post cr, pr or sd (up to 36 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and date of cr, pr or sd to 6 months post cr, pr or sd (up to 36 months) for reporting.

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 in Pain and Symptom Burden Assessment on the Modified Brief Pain Inventory-Short Form (mBPI-sf)

Change From Baseline in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)

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

+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%

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

Stomatitis

Aspartate aminotransferase increased

Dry skin

Thrombocytopenia

Pruritus

Lacrimation increased

Dehydration

Alanine aminotransferase increased

Flatulence

Urinary tract infection

Upper respiratory tract infection

Hypokalaemia

Chills

Musculoskeletal chest pain

Musculoskeletal pain

Anxiety

Rash

Gastrooesophageal reflux disease

Myalgia

Cellulitis

Pleural effusion

Atypical pneumonia

Gastroenteritis viral

Sepsis

Hip fracture

Pneumonitis

Fall

Lung infection

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

monarcHER Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: 150 mg Abemaciclib + 8 mg/kg Trastuzumab + 500 mg FulvestrantExperimental Treatment3 Interventions

150 milligram (mg) abemaciclib given orally every 12 hours (Q12H) of a 21-day cycle; plus 8 milligram per kilogram (mg/kg) trastuzumab intravenous (IV) infusion on Day 1 of the cycle then a 6 mg/kg maintenance dose IV infusion on Day 1 of each subsequent cycle; plus 500 mg fulvestrant intramuscularly (IM) on day 1, 15 and 29 and then once every 4 weeks thereafter.

Group II: 150 mg Abemaciclib + 8 mg/kg TrastuzumabExperimental Treatment2 Interventions

150 mg abemaciclib given orally Q12H of a 21-day cycle; plus 8 mg/kg trastuzumab IV infusion on Day 1 of the cycle then a 6 mg/kg maintenance dose IV infusion on Day 1 of each subsequent cycle.

Group III: 8 mg/kg Trastuzumab + Standard of Care ChemotherapyActive Control2 Interventions

8 mg/kg trastuzumab IV infusion on Day 1 of a 21-day cycle then a 6 mg/kg maintenance dose IV infusion on Day 1 of each subsequent cycle plus standard of care single agent chemotherapy of physician's choice administered according to product label

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Abemaciclib

2019

Completed Phase 2

~1710

Trastuzumab

2014

Completed Phase 4

~5190

Fulvestrant

2011

Completed Phase 3

~3690

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor

2,624 Previous Clinical Trials

3,216,787 Total Patients Enrolled

64 Trials studying Breast Cancer

36,904 Patients Enrolled for Breast Cancer

Study DirectorEli Lilly and Company

1,349 Previous Clinical Trials

415,645 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: NCT02675231 — Phase 2

Breast Cancer Research Study Groups: 150 mg Abemaciclib + 8 mg/kg Trastuzumab + 500 mg Fulvestrant, 8 mg/kg Trastuzumab + Standard of Care Chemotherapy, 150 mg Abemaciclib + 8 mg/kg Trastuzumab

Breast Cancer Clinical Trial 2023: Abemaciclib Highlights & Side Effects. Trial Name: NCT02675231 — Phase 2

Abemaciclib (CDK4/6 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02675231 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being enlisted in this research endeavor?

"At this time, no patients are being sought for the aforesaid trial which was first posted on May 23rd 2016. However, there is an abundance of other research opportunities; 2287 studies search for those with hormone receptor (hr)-positive breast cancer and 379 clinical trials seek out participants to test Abemaciclib."

Answered by AI

Is Abemaciclib generally safe for consumption by people?

"According to our team at Power, Abemaciclib is relatively safe and thus deserving of a 2 rating as there is existing evidence that it meets safety standards but no efficacy data has yet been collected."

Answered by AI

What are the conventional applications of Abemaciclib?

"Abemaciclib has established efficacy for preventing endocrine therapy, and can additionally be beneficial in managing disease, metastatic adenocarcinoma of the gastroesophageal junction, and post-surgical protocols."

Answered by AI

What prior investigations have been conducted involving Abemaciclib?

"Abemaciclib was first investigated at Ospedale di Circolo e Fondazione Macchi in 1999. Presently, there are 470 completed studies of this medication and an additional 379 enrolling patients across the globe; a considerable portion is based in East Setauket, New york."

Answered by AI

Is this research currently enrolling participants?

"This clinical trial is no longer accepting participants; it was last updated on August 8th, 2022. For those looking for alternative studies related to hormone receptor (hr)-positive breast cancer, there are 2287 trials now recruiting and 379 research initiatives that require Abemaciclib patients."

Answered by AI

What is the geographical scope of this trial’s implementation?

"Currently, 34 different clinical trial centres are participating in the recruitment process. Examples of these locations include North Shore Hematology Oncology Associates in East Setauket, Tennessee Oncology PLLC in Nashville and Northwest Medical Specialties, PLLC in Puyallup amongst other sites."

Answered by AI

Recent research and studies

The Lancet OncologyJournal

Abemaciclib Plus Trastuzumab with or Without Fulvestrant Versus Trastuzumab Plus Standard-of-care Chemotherapy in Women with Hormone Receptor-positive, Her2-positive Advanced Breast Cancer (monarcher): A Randomised, Open-label, Phase 2 Trial

Tolaney, Sara M, Andrew M Wardley, Stefania Zambelli, John F Hilton, Tiffany A Troso-Sandoval, Francesco Ricci, Seock-Ah Im, et al.. 2020. “Abemaciclib Plus Trastuzumab with or Without Fulvestrant Versus Trastuzumab Plus Standard-of-care Chemotherapy in Women with Hormone Receptor-positive, Her2-positive Advanced Breast Cancer (monarcher): A Randomised, Open-label, Phase 2 Trial”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(20)30112-1.

The Lancet OncologyJournal

clinicaltrials.govStudy

A Study of Abemaciclib (LY2835219) in Women With HR+, HER2+ Locally Advanced or Metastatic Breast Cancer

2016. "A Study of Abemaciclib (LY2835219) in Women With HR+, HER2+ Locally Advanced or Metastatic Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02675231.