Abemaciclib for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
City of Hope Medical Center, Duarte, CABreast Cancer+3 MoreAbemaciclib - Drug
Eligibility
65+
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Metastatic Breast Cancer
  • Hormone Receptor-positive Breast Cancer
  • Stage IV Breast Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

1 Primary · 15 Secondary · Reporting Duration: Up to 2 years post treatment

Year 2
Average plasma steady-state abemaciclib C-trough concentrations
Biological age via deoxyribonucleic acid (DNA) methylation level
Genome-wide methylome and transcriptome analyses
Geriatric assessment scores
Hospitalizations
Incidence of toxicities at least possibly attributable to agent
Incidence of toxicities attributable to agent
Overall survival
Pharmacokinetic (PK) parameter of plasma trough concentration
Progression free survival
Day 30
Dose holds
Incidence of grade 3 or higher toxicities
Treatment discontinuations due to factors other than progression
Up to cycle 6
Dose reductions
Incidence of toxicities
Up to end of treatment
Adherence to abemaciclib
Overall treatment utility (OTU) response
Time to end of treatment
Was It Worth It (WIWI) response

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

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Abemaciclib
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Side Effects for

Abemaciclib
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%Dysgeusia
14%Platelet count decreased
14%Dry mouth
14%Weight decreased
13%Dyspnoea
12%Abdominal pain upper
12%Back pain
12%Dizziness
11%Pyrexia
11%Blood creatinine increased
11%Oedema peripheral
11%Dyspepsia
10%Pain
9%Stomatitis
9%Aspartate aminotransferase increased
8%Thrombocytopenia
8%Lacrimation increased
8%Pruritus
8%Dry skin
8%Dehydration
8%Alanine aminotransferase increased
7%Upper respiratory tract infection
7%Flatulence
7%Urinary tract infection
7%Hypokalaemia
6%Musculoskeletal pain
6%Chills
6%Musculoskeletal chest pain
6%Anxiety
5%Myalgia
5%Gastrooesophageal reflux disease
5%Rash
2%Cellulitis
2%Pleural effusion
1%Large intestinal obstruction
1%Lung infection
1%Pneumothorax
1%Arterial thrombosis
1%Sinus bradycardia
1%Sepsis
1%Hip fracture
1%Respiratory tract infection
1%Renal function test abnormal
1%Liver function test abnormal
1%Fall
1%Pulmonary embolism
1%Gastroenteritis viral
1%Tachycardia
1%Haematotoxicity
1%Pancreatitis
1%Varices oesophageal
1%Electrocardiogram abnormal
1%Muscular weakness
1%Bone pain
1%Acute kidney injury
1%Febrile neutropenia
1%Pancreatic enzyme abnormality
1%Atypical pneumonia
1%Pneumonitis
1%Epilepsy
This histogram enumerates side effects from a completed 2018 Phase 2 trial (NCT02102490) in the Abemaciclib ARM group. Side effects include: Diarrhoea with 91%, Nausea with 67%, Fatigue with 48%, Decreased appetite with 45%, Vomiting with 35%.

Trial Design

1 Treatment Group

Treatment (abemaciclib)
1 of 1

Experimental Treatment

40 Total Participants · 1 Treatment Group

Primary Treatment: Abemaciclib · No Placebo Group · Phase 2

Treatment (abemaciclib)Experimental Group · 2 Interventions: Abemaciclib, Questionnaire Administration · Intervention Types: Drug, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abemaciclib
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years post treatment

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
525 Previous Clinical Trials
2,249,510 Total Patients Enrolled
43 Trials studying Breast Cancer
6,649 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,161 Previous Clinical Trials
41,167,343 Total Patients Enrolled
928 Trials studying Breast Cancer
1,536,821 Patients Enrolled for Breast Cancer
Mina S SedrakPrincipal InvestigatorCity of Hope Medical Center
1 Previous Clinical Trials
88 Total Patients Enrolled
Mina SedrakPrincipal InvestigatorCity of Hope Medical Center
2 Previous Clinical Trials
128 Total Patients Enrolled

Eligibility Criteria

Age 65+ · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Rewritten Criterion: You are expected to live for at least 6 more months.
Rewritten Criterion: You have a medical condition that can or cannot be measured by medical tests.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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