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CDK4/6 Inhibitor

Abemaciclib for Breast Cancer

Phase 2

Waitlist Available

Led By Ritesh Parajuli, MD

Research Sponsored by University of California, Irvine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is to see if a new combination of drugs can help people with hormone-positive breast cancer that has come back after treatment.

Eligible Conditions

Hormone Receptor-positive Breast Cancer
Breast Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of Participants With a Pathological Complete Response

Secondary outcome measures

Overall Response Rate

Percentage Change in Ki 67

Percentage of Grade 3-5 Adverse Events

+3 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%

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

Stomatitis

Aspartate aminotransferase increased

Dry skin

Thrombocytopenia

Pruritus

Lacrimation increased

Dehydration

Alanine aminotransferase increased

Flatulence

Urinary tract infection

Upper respiratory tract infection

Hypokalaemia

Chills

Musculoskeletal chest pain

Musculoskeletal pain

Anxiety

Rash

Gastrooesophageal reflux disease

Myalgia

Cellulitis

Pleural effusion

Atypical pneumonia

Gastroenteritis viral

Sepsis

Hip fracture

Pneumonitis

Fall

Lung infection

Pneumothorax

Febrile neutropenia

Respiratory tract infection

Haematotoxicity

Sinus bradycardia

Tachycardia

Large intestinal obstruction

Pancreatic enzyme abnormality

Pancreatitis

Varices oesophageal

Electrocardiogram abnormal

Liver function test abnormal

Renal function test abnormal

Bone pain

Muscular weakness

Acute kidney injury

Pulmonary embolism

Arterial thrombosis

Epilepsy

100%

80%

60%

40%

20%

Study treatment Arm

Abemaciclib

Trial Design

1Treatment groups

Experimental Treatment

Group I: Abemaciclib and FulvestrantExperimental Treatment2 Interventions

Abemaciclib will be administered orally at the dose of 150 mg twice daily. Fulvestrant will be administered intramuscularly at an initial loading dose of 500mg on days 1 and 15 of the first cycle and then 500 mg intramuscularly every first day of each subsequent cycle. One cycle is 28 days.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fulvestrant

FDA approved

Abemaciclib

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of California, IrvineLead Sponsor

542 Previous Clinical Trials

1,922,000 Total Patients Enrolled

13 Trials studying Breast Cancer

2,120 Patients Enrolled for Breast Cancer

Eli Lilly and CompanyIndustry Sponsor

2,615 Previous Clinical Trials

3,201,057 Total Patients Enrolled

64 Trials studying Breast Cancer

36,904 Patients Enrolled for Breast Cancer

Ritesh Parajuli, MD4.25 ReviewsPrincipal Investigator - Chao Family Comprehensive Cancer Center

University of California, Irvine

5Patient Review

Dr. Ritesh Parajuli MD is an excellent oncologist that I would highly recommend. I have been a patient of his for 3+ years and he has always been very knowledgeable, caring, and helpful. I trust him completely and believe that he will be able to help you just as he has helped me.

Frequently Asked Questions

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

What is the enrollment capacity of this medical study?

"Affirmative. The information hosted on clinicaltrials.gov testifies that this experiment is currently searching for participants, and was initially made public on July 23rd 2020 before being amended lastly in January 15th 2021. 32 patients are required to be recruited at a single site."

Answered by AI

What medical purpose is Abemaciclib usually prescribed for?

"Abemaciclib is a commonly used drug to battle pik3ca gene mutation, and it also has efficacy in addressing the spread of advanced hr + her2 - breast cancer, malignant neoplasms, and progression diseases."

Answered by AI

Is the enrollment process for this trial still open?

"Affirmative, the information hosted on clinicaltrials.gov indicates that this research trial is actively recruiting patients with 32 participants needed from 1 centre. The study was posted on July 23rd 2020 and last updated January 15th 2021."

Answered by AI

To what degree can Abemaciclib prove detrimental to individuals?

"Despite the fact that efficacy data is still lacking, there has been some evidence of safety for Abemaciclib. Our team at Power therefore assigned it a score of 2 on our 1-3 scale."

Answered by AI

Have any other research efforts explored Abemaciclib's potential?

"At the moment, 204 trials are underway to evaluate Abemaciclib's efficacy. Of those studies, 41 have advanced into Phase 3 clinical testing. Most of these live investigations are occurring in Alicante and Pamplona/Iruña; however, there exist 9763 different sites conducting related research."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Neo-Adjuvant Abemaciclib With Fulvestrant in Patients With ER/PR +HER Negative Breast Cancer

Ritesh Parajuli 2020. "Neo-Adjuvant Abemaciclib With Fulvestrant in Patients With ER/PR +HER Negative Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04305236.