Real-life Pan-HER-blockade With Neratinib | NCT04388384

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2, 2020Actual

Primary Completion Date

Sep 5, 2024Actual

Completion Date

Sep 5, 2024Actual

First Submitted Date

May 5, 2020

First Submission Date that Met QC Criteria

May 13, 2020

First Posted Date

May 14, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 1, 2025

Last Update Posted Date

Aug 6, 2025Actual

Name	Class
iOMEDICO AG	INDUSTRY
Pierre Fabre Pharma Austria	UNKNOWN
Pierre Fabre Pharma AG	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

So far, there is no data available on treatment of patients with early-stage hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2)-overexpressed/amplified breast cancer, who completed adjuvant trastuzumab-based therapy less than one year ago, in the clinical routine setting.

ELEANOR - designed as a prospective, longitudinal, non-interventional study (NIS) - will investigate real-world use of neratinib and its treatment management in patients with HR-positive, HER2-overexpressing/amplified breast cancer stage I-III having completed adjuvant trastuzumab-based therapy less than one year ago. Data from this study will contribute to a deeper understanding and characterization of the everyday use of neratinib in a broader patient population in the German and Austrian routine setting.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

304Actual

Name	Type	Description	Arm Group Labels	Other Names
Neratinib	Drug	Neratinib standard dose 240 mg once daily for 1 year		Nerlynx

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Patient Compliance	Rate of patients being compliant to therapy with neratinib. A patient is defined as being compliant, if she has taken the prescribed neratinib dose for at least 75% of the treatment days.	12 months of treatment

Secondary Outcomes

Measure	Description	Time Frame
Patient profile at baseline	% of patients with different demographic characteristics	Baseline
Disease profiles at baseline	% of patients with different disease characteristics

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Written informed consent of the patient with regard to the pseudonymized documentation;
Legally capable female patient ≥ 18 years of age (no upper limit);
Decision was taken to treat the patient with neratinib in accordance with the current SmPC and by prescription; this decision was taken prior to and independent from the inclusion into the study;
Treatment with neratinib is planned to be started;
Hormone receptor (HR) positive, Human epidermal growth factor receptor 2 (HER2) overexpressing/amplified breast cancer stage I-III;
Completion of prior trastuzumab-based therapy less than 1 year ago;
No signs of relapse before initiation of neratinib treatment.

Exclusion Criteria:

Presence of any contraindication with regard to the neratinib treatment as specified in the corresponding Summary of Product Characteristics (SmPC);
Current or upcoming participation in an interventional clinical trial;
Prisoners or persons who are compulsorily detained (involuntarily incarcerated)

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult female patients with HR-positive, HER2-overexpressing/amplified breast cancer stage I-III having completed adjuvant trastuzumab-based therapy less than one year ago and with a decision to receive extended adjuvant treatment with neratinib according to the current SmPC.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Corinne Vannier, Dr	Pierre Fabre Pharma GmbH	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Clinic		Klagenfurt	Carinthia	9020	Austria
Clinic

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases