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CDK4/6 Inhibitor

Abemaciclib for Older Patients with Breast Cancer

Phase 2
Recruiting
Led By Mina S Sedrak
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Measurable or non-measurable disease
Ability to read and understand English or Spanish
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years post treatment
Awards & highlights

Study Summary

This trial looks at abemaciclib as a possible treatment for breast cancer in patients age 70 and older.

Who is the study for?
This trial is for patients aged 70 or older with hormone receptor positive, HER2 negative metastatic breast cancer who have progressed on prior treatments. They must have recovered from previous therapies' side effects and not have certain infections, severe medical conditions, or a history of non-compliance to medical regimens.Check my eligibility
What is being tested?
The study tests the safety of abemaciclib monotherapy in elderly patients with advanced breast cancer. It's a phase IIa trial focusing on those who've had other treatments before. Participants will also complete questionnaires as part of the study.See study design
What are the potential side effects?
Potential side effects include gastrointestinal issues affecting drug absorption, possible liver enzyme elevations, blood cell count changes (like low ANC and platelets), and risks associated with any preexisting lung conditions like pneumonitis.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer can be measured by tests or seen on scans.
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I can read and understand either English or Spanish.
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My kidneys are functioning well enough, as shown by a test.
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My brain and spinal cord are not affected by my cancer, or they meet certain conditions.
Select...
My cancer has worsened despite previous treatments.
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I've recovered from major side effects of my last chemotherapy, with at least 3 weeks since my last dose.
Select...
I finished radiotherapy at least 14 days ago and have recovered from its immediate effects.
Select...
I am 70 years old or older.
Select...
My breast cancer has spread and this was confirmed by imaging tests.
Select...
My breast cancer is positive for estrogen and/or progesterone receptors.
Select...
I do not have lung inflammation or scarring.
Select...
My breast cancer is HER2-negative according to specific tests.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years post treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years post treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of grade 3 or higher toxicities
Secondary outcome measures
Adherence to abemaciclib
Average plasma steady-state abemaciclib C-trough concentrations
Dose holds
+12 more
Other outcome measures
Biological age via deoxyribonucleic acid (DNA) methylation level
Genome-wide methylome and transcriptome analyses
Incidence of toxicities at least possibly attributable to agent

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%
Neutropenia
18%
White blood cell count decreased
15%
Alopecia
14%
Weight decreased
14%
Dry mouth
14%
Platelet count decreased
14%
Dysgeusia
13%
Dyspnoea
12%
Abdominal pain upper
12%
Back pain
12%
Dizziness
11%
Dyspepsia
11%
Oedema peripheral
11%
Pyrexia
11%
Blood creatinine increased
10%
Pain
9%
Stomatitis
9%
Aspartate aminotransferase increased
8%
Thrombocytopenia
8%
Lacrimation increased
8%
Alanine aminotransferase increased
8%
Dehydration
8%
Dry skin
8%
Pruritus
7%
Upper respiratory tract infection
7%
Urinary tract infection
7%
Flatulence
7%
Hypokalaemia
6%
Chills
6%
Musculoskeletal chest pain
6%
Musculoskeletal pain
6%
Anxiety
5%
Gastrooesophageal reflux disease
5%
Myalgia
5%
Rash
2%
Cellulitis
2%
Pleural effusion
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%
Atypical pneumonia
1%
Gastroenteritis viral
1%
Lung infection
1%
Sepsis
1%
Fall
1%
Hip fracture
1%
Electrocardiogram abnormal
1%
Liver function test abnormal
1%
Renal function test abnormal
1%
Bone pain
1%
Muscular weakness
1%
Acute kidney injury
1%
Pneumonitis
1%
Pneumothorax
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: Treatment (abemaciclib)Experimental Treatment2 Interventions
Patients receive abemaciclib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abemaciclib
2019
Completed Phase 2
~1710

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
561 Previous Clinical Trials
1,918,209 Total Patients Enrolled
43 Trials studying Breast Cancer
6,649 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,348 Total Patients Enrolled
939 Trials studying Breast Cancer
1,543,343 Patients Enrolled for Breast Cancer
Mina S SedrakPrincipal InvestigatorCity of Hope Medical Center
2 Previous Clinical Trials
252 Total Patients Enrolled

Media Library

Abemaciclib (CDK4/6 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04305834 — Phase 2
Breast Cancer Research Study Groups: Treatment (abemaciclib)
Breast Cancer Clinical Trial 2023: Abemaciclib Highlights & Side Effects. Trial Name: NCT04305834 — Phase 2
Abemaciclib (CDK4/6 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04305834 — Phase 2

Frequently Asked Questions

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

Has Abemaciclib received confirmation from the FDA?

"Abemaciclib was ranked a 2 on our safety scale due to the absence of efficacy data, though clinical studies have been conducted to assess its security."

Answered by AI

Is this empirical research pioneering in nature?

"Presently, Abemaciclib is the subject of 92 running trials across 1276 municipalities and 41 nations. Since its initial trial in 2009 (conducted by Eli Lilly & Co., with 220 participants for Phase 1 drug approval) 209 studies have been carried out."

Answered by AI

What indications are most often linked to Abemaciclib administration?

"Abemaciclib can be employed to address high-risk cases of recurrent, advanced HR+/HER2- breast cancer and endocrine therapy."

Answered by AI

Is enrollment still open for this experiment?

"Clinicaltrials.gov confirms that this medical trial is currently enlisting study participants; it was first announced on March 25th 2020 and the most recent update came out November 1st 2022."

Answered by AI

How many participants have been recruited for this research project?

"Affirmative. The details found on clinicaltrials.gov verify that this medical investigation is actively recruiting participants, having first been posted in March of 2020 and edited most recently in November 2022. In total, 40 individuals are needed to be recruited from one site."

Answered by AI
~3 spots leftby Aug 2024