Your session is about to expire
← Back to Search
CDK4/6 Inhibitor
Abemaciclib for Triple Negative Breast Cancer
Phase 2
Recruiting
Led By Matthew P Goetz
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Residual lesion/enhancement seen in the breast on breast imaging performed after completion of neoadjuvant chemotherapy
Clinical T1-4, N0-3, M0 breast cancer at diagnosis by American Joint Committee on Cancer (AJCC) staging version 8
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 60 days
Awards & highlights
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.
Who is the study for?
This trial is for women aged 18 or older with triple negative breast cancer that remains after chemotherapy and can be surgically removed. Participants must not be pregnant, should have completed chemo within the last 56 days, and cannot use certain drugs affecting liver enzymes. They must also provide tissue samples, swallow pills, and have no other active cancers or serious medical conditions.Check my eligibility
What is being tested?
The study tests abemaciclib's effectiveness on patients with resectable triple negative breast cancer resistant to chemotherapy. It examines if this drug can halt cancer cell growth by inhibiting specific enzymes needed for their proliferation. The trial includes surgery as part of the treatment process.See study design
What are the potential side effects?
Abemaciclib may cause side effects such as diarrhea, fatigue, low white blood cell counts (increasing infection risk), nausea, abdominal pain, decreased appetite, vomiting and potential liver enzyme changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I still have signs of cancer in my breast after chemotherapy.
Select...
My breast cancer is in stages 1-4, may have spread to nearby lymph nodes, but not to distant parts of the body.
Select...
My breast cancer is confirmed to be triple negative.
Select...
I registered for the trial within 56 days after my last chemotherapy before surgery.
Select...
I am willing to have a biopsy for research purposes.
Select...
I am receiving specific chemotherapy before surgery.
Select...
I can take care of myself but might not be able to do heavy physical work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 60 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 60 days
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 moreSide effects data
From 2018 Phase 2 trial • 132 Patients • NCT0210249091%
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%
Platelet count decreased
14%
Dry mouth
14%
Weight decreased
14%
Dysgeusia
13%
Dyspnoea
12%
Abdominal pain upper
12%
Back pain
12%
Dizziness
11%
Pyrexia
11%
Dyspepsia
11%
Oedema peripheral
11%
Blood creatinine increased
10%
Pain
9%
Stomatitis
9%
Aspartate aminotransferase increased
8%
Dry skin
8%
Thrombocytopenia
8%
Pruritus
8%
Lacrimation increased
8%
Dehydration
8%
Alanine aminotransferase increased
7%
Flatulence
7%
Urinary tract infection
7%
Upper respiratory tract infection
7%
Hypokalaemia
6%
Chills
6%
Musculoskeletal chest pain
6%
Musculoskeletal pain
6%
Anxiety
5%
Rash
5%
Gastrooesophageal reflux disease
5%
Myalgia
2%
Cellulitis
2%
Pleural effusion
1%
Atypical pneumonia
1%
Gastroenteritis viral
1%
Sepsis
1%
Hip fracture
1%
Pneumonitis
1%
Fall
1%
Lung infection
1%
Pneumothorax
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%
Electrocardiogram abnormal
1%
Liver function test abnormal
1%
Renal function test abnormal
1%
Bone pain
1%
Muscular weakness
1%
Acute kidney injury
1%
Pulmonary embolism
1%
Arterial thrombosis
1%
Epilepsy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Abemaciclib
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
~9850
Abemaciclib
2019
Completed Phase 2
~1710
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,213 Previous Clinical Trials
3,766,811 Total Patients Enrolled
83 Trials studying Breast Cancer
13,810 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,667 Previous Clinical Trials
40,925,932 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
Matthew P GoetzPrincipal InvestigatorMayo Clinic in Rochester
3 Previous Clinical Trials
181 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a breast biopsy for this cancer.I still have signs of cancer in my breast after chemotherapy.I have not had any other cancer within the last 3 years.I have had a blood clot in my veins or lungs within the last year or I am currently on blood thinners for a clot.I am a woman aged 18 or older.My breast cancer is in stages 1-4, may have spread to nearby lymph nodes, but not to distant parts of the body.I can take pills by mouth.I have more than one breast cancer, with the largest being triple-negative and resistant to chemotherapy.My breast cancer is confirmed to be triple negative.Women who can have babies must have a negative pregnancy test within 7 days before joining the study.I do not have serious health issues that would stop me from joining this study.I am not currently on any experimental drugs for my cancer.I am willing to stop taking certain medications that affect my liver enzymes 7 days before joining.I have no medical reasons preventing me from getting a biopsy before joining.I registered for the trial within 56 days after my last chemotherapy before surgery.I have been treated with CDK 4/6 inhibitors before.I do not have any known infections.I am currently not on chemotherapy, radiotherapy, immunotherapy, or similar treatments.I am willing to have a biopsy for research purposes.My breast cancer is confirmed to be at stage IV.I haven't taken strong medication affecting liver enzymes in the last week.I still have side effects from earlier chemotherapy that are not mild.I have had radiation treatment for my breast cancer.I have a history of fainting due to heart issues, irregular heartbeats, or sudden cardiac arrest.Your lab test results need to be within certain ranges for Cohort B GROUP 4.I have had non-invasive breast conditions or cancer.I am receiving specific chemotherapy drugs with pembrolizumab before surgery.I am receiving specific chemotherapy before surgery.I can take care of myself but might not be able to do heavy physical work.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort A Group 1; Cohort B Group 3 (surgery)
- Group 2: Cohort A Group 2; Cohort B Group 4 (abemaciclib, surgery)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger