Treatment Patterns of Neratinib in HER2+ EBC in China

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05491057
• Other study ID #: PF008
• Status: Not yet recruiting
• Start date: September 30, 2022
• Est. completion date: June 30, 2026

Study information

• Verified date: August 2022
• Source: Pierre Fabre Medicament
• Contact: Huanying Zhen, Master
• Phone: +86010-8534-7209
• Email: nlx-pms[@]pierre-fabre.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: June 30, 2026
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Neratinib
Neratinib standard dose 240 mg once daily for 1 year

Locations

Country	Name	City	State
China	Medical Affair	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Pierre Fabre Medicament

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time of recurrence	Time from end of neratinib treatment to first invasive recurrence	12 months of treatment; 12 months of follow-up
Other	Recurrent site	% of different site of invasive tumor recurrence	12 months of treatment; 12 months of follow-up
Other	Recurrent size	% of different size of invasive tumor recurrence	12 months of treatment; 12 months of follow-up
Other	QoL - EQ-5D-5L	Median score of the EQ-5D-5L during neratinib treatment. EQ-5D-5L scale as self-reported health-related quality of life.	12 months of treatment
Other	QoL - FACIT D	Median score of the FACIT D during neratinib treatment. FACIT D scale as self-reported health-related quality of life.	12 months of treatment
Primary	Duration of Treatment	Median duration of extended adjuvant treatment with neratinib	12 months of treatment
Primary	Treatment holds and permanent discontinuations time	Median treatment holds and permanent discontinuations time	12 months of treatment
Secondary	Patient demographics	% of patients with different demographic characteristics	Baseline
Secondary	Patient characteristics	% of patients with different disease characteristics	Baseline
Secondary	Time to treatment	Median time to treatment since completion of adjuvant regimen	Baseline
Secondary	Prior adjuvant treatments	% of patients with different prior adjuvant treatments	Baseline
Secondary	Dose adjustments	% of patients with dose adjustments	12 months of treatment
Secondary	Dose intensity	Absolute and relative dose intensity	12 months of treatment
Secondary	Concomitant medication	% of patients with different concomitant medications	12 months of treatment
Secondary	Incidence of AESI	Incidence of all grades of adverse events of special interest (AESI)	12 months of treatment
Secondary	Type of AESI	% of different type of all grades of adverse events of special interest (AESI)	12 months of treatment
Secondary	Severity of AESI	% of patients with adverse events by severity	12 months of treatment
Secondary	action taken for AESI	% of patients with action taken against adverse events	12 months of treatment