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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
Adequate organ function as defined in Table 1
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2.5 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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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My organs are functioning well.
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I am post-menopausal based on age, surgery, or hormone levels.
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I can take pills by mouth.
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I have samples of my tumor available for testing.
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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've had up to 2 chemotherapy treatments for my cancer and it's been 2 weeks since my last cancer treatment.
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I have fully recovered from any side effects of my previous radiotherapy.
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I have recovered from chemotherapy side effects, except for possible hair loss or mild nerve damage.
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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.
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I am using effective birth control methods.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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%
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
9%
Stomatitis
9%
Aspartate aminotransferase increased
8%
Dry skin
8%
Thrombocytopenia
8%
Pruritus
8%
Lacrimation increased
8%
Dehydration
8%
Alanine aminotransferase increased
7%
Flatulence
7%
Urinary tract infection
7%
Upper respiratory tract infection
7%
Hypokalaemia
6%
Chills
6%
Musculoskeletal chest pain
6%
Musculoskeletal pain
6%
Anxiety
5%
Rash
5%
Gastrooesophageal reflux disease
5%
Myalgia
2%
Cellulitis
2%
Pleural effusion
1%
Atypical pneumonia
1%
Gastroenteritis viral
1%
Sepsis
1%
Hip fracture
1%
Pneumonitis
1%
Fall
1%
Lung infection
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

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
~1710
Elacestrant
2015
Completed Phase 1
~80

Find a Location

Who is running the clinical trial?

Criterium, Inc.Lead Sponsor
16 Previous Clinical Trials
730 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

Frequently Asked Questions

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

What is the maximum capacity for enrollees in this research project?

"As mandated by the inclusion criteria, 44 participants are necessary to facilitate this trial. The sponsor organization, Criterium Inc., is running it from local hospitals such as Duke Cancer Center in Durham (NC) and Cancer Care Northwest situated in Spokane Valley (WA)."

Answered by AI

Is this an experimental clinical trial?

"Presently, 93 separate clinical trials related to Abemaciclib are being conducted in 1309 cities and 42 nations. Back in 2009, Eli Lilly and Company first initiated a Phase 1 trial with 220 participants - since then 35 further studies have been completed."

Answered by AI

What maladies is Abemaciclib commonly prescribed for?

"Abemaciclib is suitable for treating a range of severe breast cancer cases, from those with an elevated risk of relapse to patients whose tumours are both HR+ and HER2-. Additionally, it can be used as part of endocrine therapy."

Answered by AI

Are there any prior experiments involving Abemaciclib that have been performed?

"Abemaciclib was originally studied in 2009 and has since been included in 35 completed clinical trials. At present, 93 active studies are ongoing with many of these conducted at Durham, North carolina's medical centres. For more information about potential enrolment sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559) during business hours Eastern Standard Time (UTC/GMT - 5 hours)."

Answered by AI

Is there open enrollment for the current trial?

"Affirmative, clinicaltrials.gov has information indicating that recruitment is currently underway for this trial which was first published on April 21st 2022. As of May 10th 2022, the study still needs 44 volunteers at 3 medical centres."

Answered by AI
~10 spots leftby Dec 2024