Abemaciclib for Breast Cancer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Breast CancerAbemaciclib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug to see if it can effectively treat early stage breast cancer that is hormone receptor positive and human epidermal receptor 2 negative.

Eligible Conditions
  • Breast Cancer

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: Baseline to Death from Any Cause (Approximately 10 Years)

Year 10
Overall Survival (OS)
Month 32
Distant Relapse-Free Survival (DRFS)
Year 10
IDFS for Participants With Ki-67 Index ≥20%
Month 32
Invasive Disease Free Survival (IDFS)
Year 3
Change From Baseline on the Functional Assessment of Cancer Therapy - Breast (FACT-B)
Year 3
Change From Baseline on the EuroQol Five-Dimension Five-Level Questionnaire (EQ-5D-5L)
Change From Baseline on the Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES)
Change From Baseline on the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
Day 30
Pharmacokinetics (PK): Minimum Steady State Concentration (Cmin,ss) of Abemaciclib

Trial Safety

Safety Progress

3 of 3
This is further along than 85% 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

1 Treatment Group

150 mg Abemaciclib + Endocrine Therapy
1 of 1

Experimental Treatment

5637 Total Participants · 1 Treatment Group

Primary Treatment: Abemaciclib · No Placebo Group · Phase 3

150 mg Abemaciclib + Endocrine TherapyExperimental Group · 2 Interventions: Abemaciclib, Standard Adjuvant Endocrine Therapy · Intervention Types: Drug, Drug
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: baseline to death from any cause (approximately 10 years)

Who is running the clinical trial?

NSABP Foundation IncNETWORK
86 Previous Clinical Trials
131,351 Total Patients Enrolled
44 Trials studying Breast Cancer
94,893 Patients Enrolled for Breast Cancer
Eli Lilly and CompanyLead Sponsor
2,466 Previous Clinical Trials
3,129,762 Total Patients Enrolled
62 Trials studying Breast Cancer
31,081 Patients Enrolled for Breast Cancer
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
363,758 Total Patients Enrolled
20 Trials studying Breast Cancer
4,975 Patients Enrolled for Breast Cancer

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
is a predictor of poor prognosis A high Ki-67 index by central analysis of untreated breast tissue is a predictor of a poor prognosis.
is a predictor of tumor recurrence for breast cancer If a breast cancer tumor is at least 5 centimeters in size, it is likely to recur.
After their non-endocrine therapy (surgery, chemotherapy, or radiation) is complete, the participant may receive up to 12 weeks of endocrine therapy before being randomized.
A participant must be randomized within 16 months of having definitive breast cancer surgery.
All women or men aged 18 or older.
The participant has confirmed that she has early stage resected invasive breast cancer without evidence of distant metastases.
The participant must have had surgery to remove the primary breast tumor.
People participating in this study must have tumor tissue from their breast (preferred) or lymph node available for exploratory biomarker analysis before they are randomized into the study.
If you have four or more positive axillary lymph nodes, your doctor will likely recommend chemotherapy.
Third grade is defined as having 8 points or more on the Bloom Richardson grading scale.

Who else is applying?

What state do they live in?
New York100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
University Hospitals Case Medical Center100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%
References