Treatment Patterns of Neratinib in HER2+ EBC in China

NCT ID: NCT05491057

Last Updated: 2022-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-30

Study Completion Date

2026-06-30

Brief Summary

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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

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Neratinib extended ajuvant treatmeng for 1 year

Neratinib

Intervention Type DRUG

Neratinib standard dose 240 mg once daily for 1 year

Interventions

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Neratinib

Neratinib standard dose 240 mg once daily for 1 year

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pierre Fabre Medicament

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Medical Affair

Shanghai, , China

Site Status

Countries

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China

Central Contacts

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Huanying Zhen, Master

Role: CONTACT

+86010-8534-7209

Shujie Pei, Master

Role: CONTACT

+86-13648686390

Facility Contacts

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Huanying Zhen, Master

Role: primary

010-85347209

Shujie Pei, Master

Role: backup

+86-13648686390

Other Identifiers

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PF008

Identifier Type: -

Identifier Source: org_study_id

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