← Back to Search

Tyrosine Kinase Inhibitor

Pharmacological Study for Breast Cancer

Phase 2
Waitlist Available
Led By Yuan Yuan
Research Sponsored by City of Hope Medical Center
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 participants are evaluated every 12 weeks, up to 48 months
Awards & highlights

Study Summary

This trial is studying the side effects and effectiveness of neratinib in treating older patients with stage IV HER2-positive breast cancer.

Eligible Conditions
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~participants are evaluated every 12 weeks, up to 48 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and participants are evaluated every 12 weeks, up to 48 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent of Participants With Grade 2 or Higher Toxicities
Secondary outcome measures
Cancer-specific Geriatric Assessment Score
Count of Participants With Grade 3 or Higher Gastrointestinal (GI) Toxicities Such as Diarrhea, Nausea and Vomiting
Median Overall Survival (OS)
+5 more

Side effects data

From 2021 Phase 1 & 2 trial • 24 Patients • NCT03010358
65%
Infusion related reaction
59%
Neutrophil count decreased
41%
Upper respiratory infection
29%
Aspartate aminotransferase increased
29%
Platelet count decreased
24%
Alanine aminotransferase increased
18%
Sinusitis
18%
Urinary tract infection
12%
Tooth infection
6%
Bronchial infection
6%
Acute Coronary Syndrome
6%
Febrile neutropenia
6%
Sepsis
6%
Infections and infestations - Other, specify
6%
Nail infection
6%
Rhinitis infective
6%
Tumor lysis syndrome
6%
Infusion Related Reaction
6%
Wound infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 2 and MTD (800 mg Entospletinib Daily)
Phase 1, Dose 1 (400 mg Entospletinib Daily)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (neratinib)Experimental Treatment4 Interventions
Patients receive neratinib 240mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Neratinib
2014
Completed Phase 2
~1970

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
565 Previous Clinical Trials
1,921,435 Total Patients Enrolled
43 Trials studying Breast Cancer
6,649 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,247 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
Yuan YuanPrincipal InvestigatorCity of Hope Comprehensive Cancer Center
6 Previous Clinical Trials
143 Total Patients Enrolled

Frequently Asked Questions

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

Are there similar drugs that have been previously studied in a clinical setting?

"There are 20 ongoing clinical trials researching Pharmacological Study. 0 of these research projects have reached Phase 3 and most originate from Richmond, Virginia. However, there are a total 130 locations running studies for Pharmacological Study across the globe."

Answered by AI

Are there any patients presently signed up for this clinical trial?

"Unfortunately, this clinical trial is not currently enrolling new patients. However, there are 2373 trials for carcinoma and 20 Pharmacological Studies that are presently searching for participants."

Answered by AI

How many hospitals are participating in this research project?

"Currently, there are 7 operational sites for this study with more to open in the future. The locations include Duarte, Mission Hills and Rancho Cucamonga. If you enroll in the program, you will be assigned to a location nearest you in order to reduce travel time requirements."

Answered by AI

What are the researchers aiming to discover through this trial?

"The primary outcome of this study is the incidence of grade 2 or higher toxicities, which will be measured over 28 days per cycle up to 1 year. Secondary objectives include volume of distribution (estimated using population PK methods), overall response rate (measured by Response Evaluation Criteria in Solid Tumors [RECIST]), and IL-6, CRP, and D-dimer analysis. Generalized linear models and graphical methods will be used to explore factors as identified by serum biomarkers that may be predictive of toxicity dose reductions, dose holds or hospitalizations."

Answered by AI

How many people are currently participating in this clinical trial?

"Unfortunately, this study is not presently looking for new participants. The original posting date was December 2nd, 2016 and the most recent update occurred on August 31st, 2022. However, there are 20 other trials in the same field that are currently enrolling patients."

Answered by AI

Has the federal government given this medication a thumbs-up?

"While there is data supporting the safety of this pharmacological study, it only exists in Phase 2 trials. This means that, while promising, there is no clinical evidence yet to support its efficacy."

Answered by AI
~3 spots leftby Apr 2025