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Abemaciclib for Breast Cancer

OHSU Knight Cancer Institute, Portland, OR
Breast Cancer+20 More ConditionsAbemaciclib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Hormone Receptor-positive Breast Cancer
  • Breast Cancer
  • Stage 2 Breast Cancer
  • Stage IA Breast Cancer
  • Stage IIA Breast Cancer
  • Stage IB Breast Cancer
  • Stage II Breast Cancer
  • Stage IIB Breast Cancer
  • Unilateral Breast Cancer
  • Stage 1 Breast Cancer
  • Stage IIIA Breast Cancer
  • Multifocal Breast Cancer
  • Stage IIIB Breast Cancer
  • HER2-negative Breast Cancer

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1

Similar Trials

1
Niraparib
1
Abemaciclib
1
Palbociclib 125mg

Study Objectives

2 Primary · 5 Secondary · Reporting Duration: Up to 5 years from the last dose of study drugs

Month 4
Rate of pathological complete response (pCR)
Rate of residual cancer burden (RCB) 0-1
Day 28
Incidence of dose limiting toxicities (DLTs) for the proposed combination
Month 5
Clinical benefit rate (CBR)
Month 4
Rate of delay to breast surgery
Month 5
Heart rate
Year 5
Incidence of myelodysplastic syndrome/acute myeloid leukemia
Month 7
Incidence of adverse events (AEs) and serious AEs for the proposed combination

Trial Safety

Phase-Based Safety

1 of 3

Similar Trials

1
Niraparib
1
Abemaciclib
2
Palbociclib 125mg

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%Thrombocytopenia
8%Lacrimation increased
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%Musculoskeletal pain
6%Chills
6%Musculoskeletal chest pain
6%Anxiety
5%Myalgia
5%Gastrooesophageal reflux disease
5%Rash
2%Cellulitis
2%Pleural effusion
1%Large intestinal obstruction
1%Lung infection
1%Pneumothorax
1%Arterial thrombosis
1%Sinus bradycardia
1%Sepsis
1%Hip fracture
1%Respiratory tract infection
1%Renal function test abnormal
1%Liver function test abnormal
1%Fall
1%Pulmonary embolism
1%Gastroenteritis viral
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
This histogram enumerates side effects from a completed 2018 Phase 2 trial (NCT02102490) in the Abemaciclib ARM group. Side effects include: Diarrhoea with 91%, Nausea with 67%, Fatigue with 48%, Decreased appetite with 45%, Vomiting with 35%.

Awards & Highlights

Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

1 Treatment Group

Treatment (abemaciclib, niraparib)
1 of 1

Experimental Treatment

8 Total Participants · 1 Treatment Group

Primary Treatment: Abemaciclib · No Placebo Group · Phase 1

Treatment (abemaciclib, niraparib)Experimental Group · 2 Interventions: Niraparib Tosylate Monohydrate, Abemaciclib · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abemaciclib
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years from the last dose of study drugs

Who is running the clinical trial?

GlaxoSmithKlineIndustry Sponsor
4,674 Previous Clinical Trials
7,960,059 Total Patients Enrolled
32 Trials studying Breast Cancer
2,326,144 Patients Enrolled for Breast Cancer
Eli Lilly and CompanyIndustry Sponsor
2,499 Previous Clinical Trials
3,155,347 Total Patients Enrolled
63 Trials studying Breast Cancer
36,814 Patients Enrolled for Breast Cancer
Oregon Health and Science UniversityOTHER
914 Previous Clinical Trials
6,830,491 Total Patients Enrolled
5 Trials studying Breast Cancer
396 Patients Enrolled for Breast Cancer
OHSU Knight Cancer InstituteLead Sponsor
214 Previous Clinical Trials
2,089,718 Total Patients Enrolled
14 Trials studying Breast Cancer
2,317 Patients Enrolled for Breast Cancer
Alexandra Zimmer, M.D.Principal InvestigatorOHSU Knight Cancer Institute
1 Previous Clinical Trials
132 Total Patients Enrolled
Evie Hobbs, M.D.Principal InvestigatorOHSU Knight Cancer Institute
1 Previous Clinical Trials
132 Total Patients Enrolled
Zahi Mitri, MD, MSPrincipal InvestigatorOHSU Knight Cancer Institute
4 Previous Clinical Trials
137 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Your blood pressure must be normal or well-controlled with medication (systolic BP less than or equal to 140 mmHg and diastolic BP less than or equal to 90 mmHg).
Both females (even if they don't have their periods anymore) and males are included in the study.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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