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
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
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
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: ProcedureGroup 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 - 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.
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Conditions
Cancer Related
Treatments