Abemaciclib for HER2-positive Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
HER2-positive Breast Cancer+1 MoreAbemaciclib - Drug
Eligibility
18+
Female
What conditions do you have?
Select

Study Summary

This trial will compare abemaciclib+trastuzumab with or without fulvestrant to trastuzumab+ standard of care chemotherapy in women with HR+, HER2+ breast cancer.

Eligible Conditions
  • Hormone Receptor Positive Breast Cancer
  • HER2-positive Breast Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 10 Secondary · Reporting Duration: Date of CR, PR or SD to 6 Months Post CR, PR or SD (Up To 36 Months)

Month 48
Overall Survival (OS)
Month 36
Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR): Objective Response Rate (ORR)
Percentage of Participants With a Best Overall Response of CR, PR, or Stable Disease (SD): Disease Control Rate (DCR)
Month 36
Progression Free Survival (PFS)
Month 36
Change From Baseline in Pain and Symptom Burden Assessment on the Modified Brief Pain Inventory-Short Form (mBPI-sf)
Change From Baseline in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Index Score
Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS)
Day 1
Pharmacokinetics (PK): Minimum Steady State Concentration (Cmin,ss) of Abemaciclib and Its Metabolites (M2 and M20)
Month 36
Duration of Response (DoR)
Month 36
Percentage of Participants With Best Overall Response of CR, PR, or SD With Duration of SD for at Least 6 Months: Clinical Benefit Rate (CBR)

Trial Safety

Safety Progress

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

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

3 Treatment Groups

8 mg/kg Trastuzumab + Standard of Care Chemotherapy
1 of 3
150 mg Abemaciclib + 8 mg/kg Trastuzumab + 500 mg Fulvestrant
1 of 3
150 mg Abemaciclib + 8 mg/kg Trastuzumab
1 of 3

Active Control

Experimental Treatment

237 Total Participants · 3 Treatment Groups

Primary Treatment: Abemaciclib · No Placebo Group · Phase 2

150 mg Abemaciclib + 8 mg/kg Trastuzumab + 500 mg FulvestrantExperimental Group · 3 Interventions: Abemaciclib, Trastuzumab, Fulvestrant · Intervention Types: Drug, Drug, Drug
150 mg Abemaciclib + 8 mg/kg TrastuzumabExperimental Group · 2 Interventions: Abemaciclib, Trastuzumab · Intervention Types: Drug, Drug
8 mg/kg Trastuzumab + Standard of Care ChemotherapyActiveComparator Group · 2 Interventions: Trastuzumab, Standard of Care Single Agent Chemotherapy · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abemaciclib
FDA approved
Trastuzumab
FDA approved
Fulvestrant
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: date of cr, pr or sd to 6 months post cr, pr or sd (up to 36 months)

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,466 Previous Clinical Trials
3,135,162 Total Patients Enrolled
Call 1-877-CTLILLY (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
1,258 Previous Clinical Trials
369,158 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Female Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have measurable disease according to RECIST version 1.1.
You have a diagnosis of HR+, HER2+ BC.
You have postmenopausal status due to surgical / natural menopause or chemical ovarian suppression.
You have no performance status (PS) of 0 to 1 on the Eastern Cooperative Oncology Group scale.
References