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CDK4/6 Inhibitor

Abemaciclib + Tamoxifen for Metastatic Breast Cancer (Next MONARCH 1 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

Have a diagnosis of HR+, HER2- breast cancer.

Relapsed or progressed following endocrine therapy.

Must not have

Have a personal history of any of the following conditions: syncope of either unexplained or cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest.

Have a history of any other cancer (except nonmelanoma skin cancer or carcinoma in-situ of the cervix or breast), unless in complete remission with no therapy for a minimum of 3 years.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 21 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing abemaciclib, a new cancer drug, to see if it is safe and effective in treating women with metastatic breast cancer that is hormone receptor-positive and human epidermal growth factor receptor 2 negative.

Who is the study for?

This trial is for women with HR+, HER2- metastatic breast cancer who've had at least two chemotherapy regimens, one of which may have been in the metastatic setting. Participants must have recovered from previous treatments, be able to swallow pills, and not be pregnant. They should not have persistent diarrhea or other cancers unless in remission for three years.

What is being tested?

The study tests the safety and effectiveness of Abemaciclib alone or combined with Tamoxifen versus standard care in women whose breast cancer has progressed after hormone therapy. The goal is to see if these drugs can help control the disease better.

What are the potential side effects?

Possible side effects include diarrhea (which can be prevented using Loperamide), fatigue, low blood cell counts leading to increased infection risk, liver problems, blood clots, and potential harm to a fetus if pregnancy occurs during treatment.

Eligibility Criteria

Inclusion Criteria

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

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My breast cancer is hormone receptor positive and HER2 negative.

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My condition worsened after hormone therapy.

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

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I can take pills by mouth.

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I've had 2 chemotherapy treatments, with 1 or 2 for advanced cancer.

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I stopped my previous cancer treatments at least 3 weeks ago and have recovered from their immediate side effects.

Exclusion Criteria

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

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I have a history of fainting, irregular heartbeats, or sudden cardiac arrest.

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I have been cancer-free from other types of cancer, except for nonmelanoma skin cancer or in-situ cervical or breast cancer, for at least 3 years.

Select...

I do not have an active infection requiring IV antibiotics or a detectable viral infection.

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I have been treated with medication targeting CDK4/6 for my cancer.

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My cancer has spread to my brain or spinal cord.

Select...

I have a long-term condition that causes ongoing diarrhea.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 21 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 21 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 21 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 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)

Duration of Response (DoR)

+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

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: Abemaciclib + TamoxifenExperimental Treatment2 Interventions

Abemaciclib given orally every 12 hours (Q12H) in combination with tamoxifen given orally every day. Participants may continue to receive treatment until discontinuation criteria are met.

Group II: Abemaciclib + Prophylactic LoperamideExperimental Treatment2 Interventions

Abemaciclib given orally Q12H in combination with prophylactic loperamide given orally. Participants may continue to receive treatment until discontinuation criteria are met.

Group III: AbemaciclibExperimental Treatment1 Intervention

Abemaciclib given orally Q12H. Participants may continue to receive treatment until discontinuation criteria are met.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Abemaciclib

2019

Completed Phase 2

~1890

Tamoxifen

2005