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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Neratinib

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Huanying Zhen, Master; Phone Number: +86010-8534-7209; Email: nlx-pms@pierre-fabre.com
• Study Contact Backup: Name: Shujie Pei, Master; Phone Number: +86-13648686390; Email: Shujie.pei@clinflash.com

Study Locations

• China
  • Shanghai, China
    • Medical Affair
    • Contact: Shujie Pei, Master; Phone Number: +86-13648686390; Email: Shujie.pei@clinflash.com
    • Contact: Huanying Zhen, Master; Phone Number: 010-85347209; Email: nlx-pms@pierre-fabre.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients assigned extended adjuvant treatment with neratinib for 12 months for their HER2-positive, early-stage breast cancer.

Description

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).

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Neratinib extended ajuvant treatmeng for 1 year	Drug: Neratinib; Neratinib standard dose 240 mg once daily for 1 year

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient demographics	% of patients with different demographic characteristics	Baseline
Patient characteristics	% of patients with different disease characteristics	Baseline
Time to treatment	Median time to treatment since completion of adjuvant regimen	Baseline
Prior adjuvant treatments	% of patients with different prior adjuvant treatments	Baseline
Dose adjustments	% of patients with dose adjustments	12 months of treatment
Dose intensity	Absolute and relative dose intensity	12 months of treatment
Concomitant medication	% of patients with different concomitant medications	12 months of treatment
Incidence of AESI	Incidence of all grades of adverse events of special interest (AESI)	12 months of treatment
Type of AESI	% of different type of all grades of adverse events of special interest (AESI)	12 months of treatment
Severity of AESI	% of patients with adverse events by severity	12 months of treatment
action taken for AESI	% of patients with action taken against adverse events	12 months of treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of recurrence	Time from end of neratinib treatment to first invasive recurrence	12 months of treatment； 12 months of follow-up
Recurrent site	% of different site of invasive tumor recurrence	12 months of treatment； 12 months of follow-up
Recurrent size	% of different size of invasive tumor recurrence	12 months of treatment； 12 months of follow-up
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
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

Collaborators and Investigators

• Sponsor: Pierre Fabre Medicament

Study record dates

Study Major Dates

• Study Start (Anticipated): September 30, 2022
• Primary Completion (Anticipated): December 30, 2025
• Study Completion (Anticipated): June 30, 2026

Study Registration Dates

• First Submitted: July 27, 2022
• First Submitted That Met QC Criteria: August 4, 2022
• First Posted (Actual): August 8, 2022

Study Record Updates

• Last Update Posted (Actual): August 8, 2022
• Last Update Submitted That Met QC Criteria: August 4, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: PF008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes