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CDK4/6 Inhibitor

Abemaciclib for Triple Negative Breast Cancer

Mayo Clinic in Rochester, Rochester, MN
Targeting 25 different conditionsAbemaciclib +1 morePhase 2RecruitingLed by Matthew P GoetzResearch Sponsored by Mayo Clinic

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 Cancer
  • Breast Cancer
  • Fibrocystic Breast Disease

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
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Carboplatin may be included in the treatment plan.
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Carboplatin might be included in the treatment plan.
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Carboplatin might be included in these treatment plans.
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It’s okay if you have non-cancerous breast disease, or DCIS or LCIS in the opposite breast.
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You can participate in the study if you have breast cancer on one side, but it must be less severe than the cancer being studied. All biopsies and tissue samples will be taken from the more severe cancer.
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Carboplatin may be included in the treatment plan.
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You are willing to have a small amount of tissue removed for research purposes.
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You agree to give tissue and blood samples for research purposes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to prior to surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to prior to surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
Secondary outcome measures
Changes in vimentin expression
Impact of length of treatment
Incidence of adverse events
Other outcome measures
Change in in frequency of JAK-2 amplifications
Change in microbiome with exposure to abemaciclib
Changes in E-Cadherin
+11 more

Side effects data

From 2018 Phase 2 trial • 132 Patients • NCT02102490
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%
Neutropenia
18%
White blood cell count decreased
15%
Alopecia
14%
Weight decreased
14%
Dry mouth
14%
Platelet count decreased
14%
Dysgeusia
13%
Dyspnoea
12%
Abdominal pain upper
12%
Back pain
12%
Dizziness
11%
Dyspepsia
11%
Oedema peripheral
11%
Pyrexia
11%
Blood creatinine increased
10%
Pain
9%
Stomatitis
9%
Aspartate aminotransferase increased
8%
Thrombocytopenia
8%
Lacrimation increased
8%
Alanine aminotransferase increased
8%
Dehydration
8%
Dry skin
8%
Pruritus
7%
Urinary tract infection
7%
Upper respiratory tract infection
7%
Flatulence
7%
Hypokalaemia
6%
Chills
6%
Musculoskeletal chest pain
6%
Musculoskeletal pain
6%
Anxiety
5%
Gastrooesophageal reflux disease
5%
Myalgia
5%
Rash
2%
Cellulitis
2%
Pleural effusion
1%
Febrile neutropenia
1%
Respiratory tract infection
1%
Haematotoxicity
1%
Sinus bradycardia
1%
Tachycardia
1%
Large intestinal obstruction
1%
Pancreatic enzyme abnormality
1%
Pancreatitis
1%
Varices oesophageal
1%
Atypical pneumonia
1%
Gastroenteritis viral
1%
Lung infection
1%
Sepsis
1%
Fall
1%
Hip fracture
1%
Electrocardiogram abnormal
1%
Liver function test abnormal
1%
Renal function test abnormal
1%
Bone pain
1%
Muscular weakness
1%
Acute kidney injury
1%
Pneumonitis
1%
Pneumothorax
1%
Pulmonary embolism
1%
Arterial thrombosis
1%
Epilepsy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Abemaciclib

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort A Group 2; Cohort B Group 4 (abemaciclib, surgery)Experimental Treatment2 Interventions
Patients receive abemaciclib PO BID on days 1-14 or days 1-21 in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care surgical resection no later than 12 weeks after the last dose of neoadjuvant chemotherapy.
Group II: Cohort A Group 1; Cohort B Group 3 (surgery)Experimental Treatment1 Intervention
Patients undergo standard of care surgical resection.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Therapeutic Conventional Surgery
2005
Completed Phase 3
~9860
Abemaciclib
2019
Completed Phase 2
~1440

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,114 Previous Clinical Trials
3,502,775 Total Patients Enrolled
83 Trials studying Breast Cancer
14,089 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,489 Previous Clinical Trials
41,266,477 Total Patients Enrolled
934 Trials studying Breast Cancer
1,540,727 Patients Enrolled for Breast Cancer
Matthew P GoetzPrincipal InvestigatorMayo Clinic in Rochester
3 Previous Clinical Trials
181 Total Patients Enrolled

Media Library

Abemaciclib (CDK4/6 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03979508 — Phase 2
Breast Cancer Research Study Groups: Cohort A Group 2; Cohort B Group 4 (abemaciclib, surgery), Cohort A Group 1; Cohort B Group 3 (surgery)
Breast Cancer Clinical Trial 2023: Abemaciclib Highlights & Side Effects. Trial Name: NCT03979508 — Phase 2
Abemaciclib (CDK4/6 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03979508 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Abemaciclib known to cause any adverse effects in patients?

"Abemaciclib's safety is supported by Phase 2 clinical data, but since there is no efficacy data, it received a score of 2."

Answered by AI

Have these findings been seen before?

"Abemaciclib was first studied in 2009 in an Eli Lilly and Company-sponsored clinical trial. After the first Phase 1 study involving 220 people, the drug received approval. 96 studies are currently ongoing in 1273 cities and 41 countries."

Answered by AI

What does Abemaciclib help patients with the most?

"Abemaciclib is most commonly used as an intervention for high risk of recurrence. It can also be used to treat multiple other conditions, like advanced hormone receptor positive, human epidermal growth factor negative breast cancer, endocrine therapy, and breast."

Answered by AI

What other scientific literature is there on Abemaciclib?

"Abemaciclib was first studied in 2009. If you would like more information about where this clinical trial is taking place, you can call 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday through Friday from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician. 63 studies have completed since the original research was conducted and 96 are currently ongoing, a large portion of which are based in Scottsdale, Arizona."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Abemaciclib in Treating Patients With Surgically Resectable, Chemotherapy Resistant, Triple Negative Breast Cancer
2020. "Abemaciclib in Treating Patients With Surgically Resectable, Chemotherapy Resistant, Triple Negative Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03979508.
All > Breast Cancer Glendale > Triple Negative Breast Cancer
~30 spots leftby Jul 2024
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