Treatment Patterns of Neratinib in HER2+ EBC in China
A Multicenter, Open-label, Single-arm, Non-interventional Study to Investigate the Treatment Patterns of Nerlynx® (Neratinib) in HER2-positive Early-stage Breast Cancer in China
1 other identifier
observational
500
1 country
1
Brief Summary
This is a multicenter, open-label, single-arm, non-interventional study to investigate the treatment patterns of Neratinib in HER2-positive early-stage breast cancer in China
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2022
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 27, 2022
CompletedFirst Posted
Study publicly available on registry
August 8, 2022
CompletedStudy Start
First participant enrolled
September 30, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
ExpectedAugust 8, 2022
August 1, 2022
3.3 years
July 27, 2022
August 4, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Duration of Treatment
Median duration of extended adjuvant treatment with neratinib
12 months of treatment
Treatment holds and permanent discontinuations time
Median treatment holds and permanent discontinuations time
12 months of treatment
Secondary Outcomes (11)
Patient demographics
Baseline
Patient characteristics
Baseline
Time to treatment
Baseline
Prior adjuvant treatments
Baseline
Dose adjustments
12 months of treatment
- +6 more secondary outcomes
Other Outcomes (5)
Time of recurrence
12 months of treatment； 12 months of follow-up
Recurrent site
12 months of treatment； 12 months of follow-up
Recurrent size
12 months of treatment； 12 months of follow-up
- +2 more other outcomes
Study Arms (1)
Neratinib extended ajuvant treatmeng for 1 year
Interventions
Neratinib standard dose 240 mg once daily for 1 year
Eligibility Criteria
Patients assigned extended adjuvant treatment with neratinib for 12 months for their HER2-positive, early-stage breast cancer.
You may qualify if:
- Signed written informed consent approved by the reviewing Ethics Committee (EC).
- Adult patients (≥18 years of age, no upper limit).
- Eligible to receive neratinib for extended adjuvant treatment as per prescribing information in China, diagnosed with HER2 overexpressing/amplified early-stage breast cancer regardless of hormone receptor (HR) status and clinical/radiological assessed to be negative for recurrences or metastatic disease.
You may not qualify if:
- Presence of any contraindication with regard to the neratinib treatment.
- Current or upcoming participation in an interventional clinical trial. (Investigational treatment within four weeks of enrolment).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical Affair
Shanghai, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 27, 2022
First Posted
August 8, 2022
Study Start
September 30, 2022
Primary Completion
December 30, 2025
Study Completion (Estimated)
June 30, 2026
Last Updated
August 8, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share