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Trial Title:
Treatment Patterns of Neratinib in HER2+ EBC in China
NCT ID:
NCT05491057
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Neratinib
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Neratinib
Description:
Neratinib standard dose 240 mg once daily for 1 year
Arm group label:
Neratinib extended ajuvant treatmeng for 1 year
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
Criteria for eligibility:
Study pop:
Patients assigned extended adjuvant treatment with neratinib for 12 months for their
HER2-positive, early-stage breast cancer.
Sampling method:
Non-Probability Sample
Criteria:
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).
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Medical Affair
Address:
City:
Shanghai
Country:
China
Contact:
Last name:
Huanying Zhen, Master
Phone:
010-85347209
Email:
nlx-pms@pierre-fabre.com
Contact backup:
Last name:
Shujie Pei, Master
Phone:
+86-13648686390
Email:
Shujie.pei@clinflash.com
Start date:
September 30, 2022
Completion date:
June 30, 2026
Lead sponsor:
Agency:
Pierre Fabre Medicament
Agency class:
Industry
Source:
Pierre Fabre Medicament
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05491057