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Abemaciclib for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Breast Cancer+1 MoreAbemaciclib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial is testing a new cancer drug combo to see if it's safe and effective against NSCLC and HR+ breast cancer.

Eligible Conditions
  • Non-Small Cell Lung Cancer
  • Breast Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

2 Primary · 6 Secondary · Reporting Duration: Baseline to Date of Death Due to Any Cause (Approximately 18 Months)

Month 6
Number of Participants with Non-Serious Adverse Event(s)
Number of Participants with One or More Serious Adverse Event(s) (SAEs)
Month 18
Overall Survival (OS)
Month 10
Progression Free Survival (PFS) per RECIST v1.1
Month 6
Disease Control Rate (DCR) per RECIST v1.1: Percentage of Participants With a Best Overall Response of Complete Response, Partial Response, and Stable Disease
Objective Response Rate (ORR) per RECIST v1.1: Percentage of Participants With a Complete or Partial Response
Month 12
Duration of Response (DoR) per RECIST v1.1
Day 21
Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib in Combination with Pembrolizumab with or without Anastrozole

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Intensity-Modulated Radiation Therapy
2
Tislelizumab
2
TAS-102

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%Lacrimation increased
8%Thrombocytopenia
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%Chills
6%Musculoskeletal chest pain
6%Musculoskeletal pain
6%Anxiety
5%Myalgia
5%Gastrooesophageal reflux disease
5%Rash
2%Cellulitis
2%Pleural effusion
1%Lung infection
1%Sinus bradycardia
1%Arterial thrombosis
1%Sepsis
1%Hip fracture
1%Respiratory tract infection
1%Renal function test abnormal
1%Liver function test abnormal
1%Fall
1%Pneumothorax
1%Pulmonary embolism
1%Gastroenteritis viral
1%Large intestinal obstruction
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

4 Treatment Groups

HR+, HER2- Locally Advanced or Metastatic Breast Cancer
1 of 4
NSCLC Squamous
1 of 4
NSCLC KRAS mt, PD-L1+
1 of 4
HR+, HER2- Metastatic Breast Cancer
1 of 4

Experimental Treatment

100 Total Participants · 4 Treatment Groups

Primary Treatment: Abemaciclib · No Placebo Group · Phase 1

HR+, HER2- Locally Advanced or Metastatic Breast CancerExperimental Group · 3 Interventions: Abemaciclib, Pembrolizumab, Anastrozole · Intervention Types: Drug, Drug, Drug
NSCLC SquamousExperimental Group · 2 Interventions: Abemaciclib, Pembrolizumab · Intervention Types: Drug, Drug
NSCLC KRAS mt, PD-L1+Experimental Group · 2 Interventions: Abemaciclib, Pembrolizumab · Intervention Types: Drug, Drug
HR+, HER2- Metastatic Breast CancerExperimental Group · 2 Interventions: Abemaciclib, Pembrolizumab · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abemaciclib
FDA approved
Pembrolizumab
FDA approved
Anastrozole
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to date of death due to any cause (approximately 18 months)

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,465 Previous Clinical Trials
3,135,272 Total Patients Enrolled
62 Trials studying Breast Cancer
36,618 Patients Enrolled for Breast Cancer
Merck Sharp & Dohme LLCIndustry Sponsor
3,673 Previous Clinical Trials
4,958,804 Total Patients Enrolled
52 Trials studying Breast Cancer
6,801 Patients Enrolled for Breast Cancer
Call 1-877-CTILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)Study DirectorEli Lilly and Company
1 Previous Clinical Trials
2 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

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References

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