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Pharmacological Study for Breast Cancer
Study Summary
This trial is studying the side effects and effectiveness of neratinib in treating older patients with stage IV HER2-positive breast cancer.
- Breast Cancer
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2021 Phase 1 & 2 trial • 24 Patients • NCT03010358Trial Design
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Who is running the clinical trial?
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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