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Cyclin-Dependent Kinase Inhibitor

Abemaciclib + Niraparib for Breast Cancer

Phase 1
Waitlist Available
Led By Evie Hobbs, M.D.
Research Sponsored by OHSU Knight Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
Participants must be planned for neoadjuvant chemotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years from the last dose of study drugs
Awards & highlights

Study Summary

This trial is testing the side effects and best dose of two drugs, abemaciclib and niraparib, to treat patients with hormone receptor positive breast cancer that is negative for HER2. Abemaciclib works by blocking proteins that are needed for cell growth, and niraparib inhibits a protein that helps repair DNA mutations. The combination of these two drugs may make the tumor smaller before surgery.

Who is the study for?
This trial is for individuals with hormone receptor positive, HER2 negative breast cancer who haven't had prior cancer treatment (except endocrine therapy) and are planning surgery. They must have satisfactory lab results, agree to use contraception if applicable, not be pregnant or breastfeeding, and can't have certain heart conditions or a history of other cancers within the last 5 years.Check my eligibility
What is being tested?
The trial tests the combination of two drugs before surgery: Abemaciclib which blocks proteins needed for cell growth, and Niraparib which prevents tumor cells from repairing DNA damage. The goal is to see how well these work together to shrink tumors in patients with specific types of breast cancer.See study design
What are the potential side effects?
Potential side effects include issues related to blocking cell growth and DNA repair such as fatigue, nausea, low blood counts leading to increased infection risk or bleeding problems. There may also be liver function changes and risks associated with taking oral medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or can carry out light work.
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I am scheduled for chemotherapy before surgery.
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My cancer is positive for estrogen or progesterone receptors.
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I agree to have a biopsy for research.
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My breast cancer is in an early stage and surgery aims to cure it.
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I have breast cancer in one breast with multiple tumors.
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I haven't had cancer treatment for my breast cancer, except for hormone therapy.
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I can take pills by mouth.
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My cancer is not HER2 amplified according to recent guidelines.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years from the last dose of study drugs
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years from the last dose of study drugs for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events (AEs) and serious AEs for the proposed combination
Incidence of dose limiting toxicities (DLTs) for the proposed combination
Secondary outcome measures
Clinical benefit rate (CBR)
Heart rate
Rate of delay to breast surgery
+2 more
Other outcome measures
Incidence of myelodysplastic syndrome/acute myeloid leukemia

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
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

1Treatment groups
Experimental Treatment
Group I: Treatment (abemaciclib, niraparib)Experimental Treatment2 Interventions
Patients receive abemaciclib PO BID and niraparib PO QD. Treatment repeats every 28 days for up to 2-4 cycles in the absence of disease progression or unacceptable toxicity. Patients who complete 4 cycles undergo standard of care mastectomy or lumpectomy. Patients demonstrating progressive disease after only 2 cycles are switched to receive standard of care chemotherapy prior to undergoing mastectomy or lumpectomy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abemaciclib
2019
Completed Phase 2
~1710

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineIndustry Sponsor
4,750 Previous Clinical Trials
8,067,444 Total Patients Enrolled
32 Trials studying Breast Cancer
2,326,304 Patients Enrolled for Breast Cancer
Eli Lilly and CompanyIndustry Sponsor
2,613 Previous Clinical Trials
3,200,921 Total Patients Enrolled
64 Trials studying Breast Cancer
36,904 Patients Enrolled for Breast Cancer
Oregon Health and Science UniversityOTHER
973 Previous Clinical Trials
6,846,021 Total Patients Enrolled
5 Trials studying Breast Cancer
396 Patients Enrolled for Breast Cancer

Media Library

Abemaciclib (Cyclin-Dependent Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04481113 — Phase 1
Breast Cancer Research Study Groups: Treatment (abemaciclib, niraparib)
Breast Cancer Clinical Trial 2023: Abemaciclib Highlights & Side Effects. Trial Name: NCT04481113 — Phase 1
Abemaciclib (Cyclin-Dependent Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04481113 — Phase 1

Frequently Asked Questions

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

How many participants are enrolled in this research study?

"Affirmative. According to records found on clinicaltrials.gov, this trial is still in search of 25 individuals from 1 centre. It was first made public on June 7th 2021 and its details were revised for the last time on July 29th 2022."

Answered by AI

To what degree is Abemaciclib considered to be a secure medical treatment for patients?

"There is a limited amount of data regarding Abemaciclib's safety and efficacy, so it received the lowest score of 1."

Answered by AI

What are the desired outcomes of this clinical experiment?

"Eli Lilly and Company, the clinical trial sponsor, reports that its primary outcome is the incidence of dose-limiting toxicities (DLTs) over a period up to 90 days after receiving the final dosage. Additionally, secondary outcomes such as rate of residual cancer burden (RCB), delay in breast surgery attributed to treatment-related toxicity, and pathological complete response (pCR) will be tabulated proportionally and analyzed descriptively."

Answered by AI

Are there any precedent investigations involving Abemaciclib?

"Presently, 189 clinical trials involving Abemaciclib are in progress. 29 of these active studies have advanced to Phase 3. Although most of the research is based out of Washington D.C., 7797 locations across the country are running related studies for this drug."

Answered by AI

In what cases is Abemaciclib usually prescribed?

"Abemaciclib is a viable therapeutic option for those suffering from disease, high risk of recurrence, and primary peritoneal cancer."

Answered by AI

Is this endeavor a pioneering effort in its field?

"Since its inception in 2009, Eli Lilly and Company has conducted a total of 48 studies on Abemaciclib. Currently active trials are being held across 1482 cities in 52 different countries. The initial trial was composed of 220 patients and achieved Phase 1 drug approval status."

Answered by AI

Is the enrollment process still open for this experiment?

"Affirmative. The information hosted on clinicaltrials.gov reveals that this investigation, initially posted in June of 2021, is actively trying to recruit patients. 25 volunteers must be sourced from a single medical centre."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Abemaciclib and Niraparib Before Surgery for the Treatment of Hormone Receptor Positive HER2 Negative Breast Cancer
Alexandra Zimmer 2021. "Abemaciclib and Niraparib Before Surgery for the Treatment of Hormone Receptor Positive HER2 Negative Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04481113.
~0 spots leftby Jun 2024
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