Abemaciclib for Triple Negative Breast Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Triple Negative Breast Carcinoma+34 More
Abemaciclib - Drug
Eligibility
18+
Female
What conditions do you have?
Select

Study Summary

This trial is testing abemaciclib as a treatment for triple negative breast cancer. Abemaciclib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Eligible Conditions
  • Triple Negative Breast Carcinoma
  • Breast
  • Ductal Carcinoma
  • Anatomic Stage III Breast Cancer AJCC v8
  • Carcinoma
  • Invasive Breast Carcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Up to 60 days

Baseline up to prior to surgery
Change in microbiome with exposure to abemaciclib
Baseline up to time of surgery
Change in in frequency of JAK-2 amplifications
Up to 21 days
Proportion of patients who have a CD8/FOXP3 ratio < 1.6 in their residual tumors after neoadjuvant chemotherapy (NAC) that convert to CD8/FOXP3 ratio >= 1.6
Up to 60 days
Changes in E-Cadherin
Changes in SLUG
Changes in SNAIL
Changes in mitoses
Changes in nuclear pleomorphism
Changes in serum tyrosine kinase inhibitor (TKI)
Changes in tubule formation
Changes in tumor Ki-67
Changes in tumor-infiltrating lymphocytes
Changes in vimentin expression
Effect of abemaciclib on formalin-fixed paraffin-embedded (FFPE) tumor sections
Effect of abemaciclib on the phenotype of peripheral blood mononuclear cells (PBMC)
Effect of abemaciclib on tumor ribonucleic acid (RNA)-sequencing (seq) data
Impact of length of treatment
Incidence of adverse events

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

2 Treatment Groups

Group 1 (surgery)
1 of 2
Group 2 (abemaciclib, surgery)
1 of 2

Experimental Treatment

100 Total Participants · 2 Treatment Groups

Primary Treatment: Abemaciclib · No Placebo Group · Phase 2

Group 1 (surgery)
Procedure
Experimental Group · 1 Intervention: Therapeutic Conventional Surgery · Intervention Types: Procedure
Group 2 (abemaciclib, surgery)Experimental Group · 2 Interventions: Therapeutic Conventional Surgery, Abemaciclib · Intervention Types: Procedure, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Therapeutic Conventional Surgery
2005
Completed Phase 3
~8410
Abemaciclib
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 60 days

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,005 Previous Clinical Trials
41,301,827 Total Patients Enrolled
64 Trials studying Triple Negative Breast Carcinoma
11,027 Patients Enrolled for Triple Negative Breast Carcinoma
Mayo ClinicLead Sponsor
2,896 Previous Clinical Trials
3,699,221 Total Patients Enrolled
4 Trials studying Triple Negative Breast Carcinoma
96 Patients Enrolled for Triple Negative Breast Carcinoma
Matthew P GoetzPrincipal InvestigatorMayo Clinic in Rochester
3 Previous Clinical Trials
181 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Female Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Breast cancer patients with T1-4, N0-3, M0 tumors are eligible for this study.
Breast cancer in the other breast is allowed.
You are receiving docetaxel in combination with doxorubicin and cyclophosphamide (TAC).

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 8th, 2021

Last Reviewed: November 7th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.