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Tyrosine Kinase Inhibitor

Trastuzumab for Breast Cancer

Phase 2

Waitlist Available

Led By Jo Chien, MD

Research Sponsored by University of California, San Francisco

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 55 weeks

Awards & highlights

Study Summary

This trial studies diarrhea in patients with stage II-IIIC HER2 Positive breast cancer treated with trastuzumab and neratinib.

Eligible Conditions

Breast Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 55 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 55 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 55 weeks for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Number of Participants Who Discontinued Neratinib Early

Number of Participants With Neratinib Dose Holds

Number of Participants With Neratinib Dose-reductions

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (Neratinib)Experimental Treatment4 Interventions

Patients will receive up to 240mg neratinib to be taken continuously in 21-day cycles once a day for up to 55 weeks on study with no rest between cycles unless related to toxicity. Patients will receive Neratinib and may also be prescribed standard of care maintenance adjuvant trastuzumab (duration of maintenance trastuzumab is at the discretion of the treating physician), for up to 55 weeks. If applicable, after the completion of trastuzumab maintenance therapy (determined by treating physician), neratinib may continue as monotherapy to complete a maximum of 55 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Trastuzumab

2014

Completed Phase 4

~5190

Loperamide

2010

Completed Phase 4

~2160

Neratinib

2014

Completed Phase 2

~1970

Diphenoxylate Hydrochloride/Atropine Sulfate

2018

Completed Phase 2

~20

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Find a Location

Who is running the clinical trial?

Puma Biotechnology, Inc.Industry Sponsor

57 Previous Clinical Trials

9,931 Total Patients Enrolled

14 Trials studying Breast Cancer

4,397 Patients Enrolled for Breast Cancer

University of California, San FranciscoLead Sponsor

2,505 Previous Clinical Trials

15,237,544 Total Patients Enrolled

46 Trials studying Breast Cancer

3,828,435 Patients Enrolled for Breast Cancer

Jo Chien, MD5.02 ReviewsPrincipal Investigator - University of California, San Francisco

University of California, San Francisco

1 Previous Clinical Trials

17 Total Patients Enrolled

Frequently Asked Questions

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

What therapeutic applications does Neratinib have?

"Neratinib can be employed to quell the effects of inflammatory breast cancer (IBC), prevent intestinal stoma leakage, and even mollify laughing."

Answered by AI

Is this clinical research currently seeking volunteers?

"According to the data on clinicaltrials.gov, this medical trial is not currently searching for participants at this time; it was initially posted in October 2018 and last updated on February 14th 2022. Nevertheless, there are still 2596 other studies actively enrolling patients around the world."

Answered by AI

How many people have enrolled in this research endeavor?

"Patient recruitment for this trial has ceased - it was initially published on the 9th of October 2018, and the last edits were made to its listing on February 14th 2022. For those seeking out other studies related to breast cancer, there are 2362 active trials, while 234 clinical trials remain open for Neratinib treatments."

Answered by AI

Are there any precedents for experimental treatments involving Neratinib?

"Currently, 234 clinical trials are ongoing that research Neratinib. Of these studies, 56 have progressed to Phase 3 and are located primarily in Seattle, Washington; worldwide there a total of 14 852 sites running investigations with this medication."

Answered by AI