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Cyclin-Dependent Kinase Inhibitor

Abemaciclib + Elacestrant for Breast Cancer with Brain Metastasis

Phase 1 & 2
Recruiting
Led By Peter Kabos, MD
Research Sponsored by Criterium, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Post-menopausal status as defined by documented surgical bilateral oophorectomy, age > 59 years with amenorrhea for > 1 year since last menses, or age < 60 years with amenorrhea for > 1 year since last menses and serum estradiol and FSH in post-menopausal laboratory range
Post-menopausal women with histologically or cytologically diagnosed metastatic HR+/Her2- breast cancer defined as positive for estrogen receptor or progesterone receptor and negative for HER2 amplification
Must not have
Women who are pre-menopausal
Have any medical condition that would impair the administration of oral agents
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2.5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new cancer drug combo on patients with HR+/Her2- breast cancer that has spread to the brain.

Who is the study for?
This trial is for post-menopausal women with HR+/Her2- breast cancer that has spread to the brain. They can have had up to two chemotherapy treatments for advanced disease but must be recovered from major treatment effects. Participants need good organ function, no severe medical conditions, and not be on other investigational drugs. They cannot have used Abemaciclib or Elacestrant before.
What is being tested?
The study tests a combination of Abemaciclib and Elacestrant in patients whose breast cancer has metastasized to the brain. It's an open-label Phase Ib/II trial allowing prior endocrine therapy use, aiming to assess the effectiveness and safety of this drug combo.
What are the potential side effects?
Potential side effects may include fatigue, digestive issues, blood disorders, hormonal imbalances due to endocrine therapy interference, possible neurological symptoms related to brain metastasis treatment, and general discomfort from taking oral medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am post-menopausal based on age, surgery, or hormone levels.
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I am a post-menopausal woman with a specific type of breast cancer that is positive for hormone receptors and negative for HER2.
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I can take care of myself but might not be able to do heavy physical work.
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My brain cancer has grown despite previous treatments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am a woman and have not gone through menopause.
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I have no conditions that prevent me from taking pills.
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I currently have an active infection (bacterial, fungal, or viral).
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I am not pregnant, breastfeeding, or a man.
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I am under 18 years old.
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I do not have any serious uncontrolled medical or mental health conditions.
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I have previously used abemaciclib or elacestrant.
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I have had more than two seizures in the past month.
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I have a history of fainting due to heart issues, irregular heartbeats, or sudden cardiac arrest.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2.5 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
Assess the efficacy of the drug combination abemaciclib and elacestrant.
The number of patients in Phase 1b part of the study with any adverse events (AE).
Secondary study objectives
Evaluate duration of tumor response rates of treatment with abemaciclib and elacestrant combination.
Evaluate tumor response rates of treatment with abemaciclib and elacestrant combination.
The percentage of patients to complete the study.

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
9%
Stomatitis
9%
Aspartate aminotransferase increased
8%
Thrombocytopenia
8%
Lacrimation increased
8%
Dehydration
8%
Dry skin
8%
Pruritus
8%
Alanine aminotransferase increased
7%
Flatulence
7%
Upper respiratory tract infection
7%
Urinary tract infection
7%
Hypokalaemia
6%
Chills
6%
Musculoskeletal chest pain
6%
Musculoskeletal pain
6%
Anxiety
5%
Gastrooesophageal reflux disease
5%
Rash
5%
Myalgia
2%
Cellulitis
2%
Pleural effusion
1%
Atypical pneumonia
1%
Gastroenteritis viral
1%
Lung infection
1%
Sepsis
1%
Fall
1%
Hip fracture
1%
Pneumonitis
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Abemaciclib/ElacestrantExperimental Treatment2 Interventions
Abemaciclib and Elacestrant combination
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abemaciclib
2019
Completed Phase 2
~1890
Elacestrant
2019
Completed Phase 3
~560

Find a Location

Who is running the clinical trial?

Criterium, Inc.Lead Sponsor
17 Previous Clinical Trials
748 Total Patients Enrolled
3 Trials studying Breast Cancer
172 Patients Enrolled for Breast Cancer
Peter Kabos, MDPrincipal InvestigatorUniversity of Colorado, Denver

Media Library

Abemaciclib (Cyclin-Dependent Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04791384 — Phase 1 & 2
Breast Cancer Research Study Groups: Abemaciclib/Elacestrant
Breast Cancer Clinical Trial 2023: Abemaciclib Highlights & Side Effects. Trial Name: NCT04791384 — Phase 1 & 2
Abemaciclib (Cyclin-Dependent Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04791384 — Phase 1 & 2
~12 spots leftby Jan 2026
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