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Completed

NCT Number: NCT05599334

A Retrospective Observational Study of Patients With Early-stage HER2-positive Breast Cancer, Treated With Neratinib

The purpose of this study is to describe the demographic and clinical profiles of patients with early-stage HER2+ breast cancer treated with neratinib as an extended adjuvant therapy as part of the Early Access Program (EAP) in Europe.

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Key information

Conditions

Breast Cancer Adjuvant Therapy Breast Diseases Breast Neoplasms HER2-positive Breast Cancer Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinique Saint-Luc Bouge, Bouge, Belgium

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About this study

Eligible patients were selected among those who had received at least one dose of neratinib in the context of the early access program conducted in Europe between 01 August 2017 and 31 December 2020 (the patient identification period) and residing in one of the five target following countries: Belgium, Croatia, France, Italy and Spain, which were part of the EAP. Patients were followed up until the end of the study observation period/study entry date (05 July 2022). As this study was retrospective, the decision to prescribe neratinib was taken prior to and independent of the proposal to select a patient for this study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients will be eligible for inclusion if they fulfill all of the following criteria:
  • Age ≥ 18 years at neratinib treatment initiation
  • Having received at least one initial dose of neratinib as an extended adjuvant therapy for the treatment of early-stage HER2+ breast cancer, in the context of the EAP in Europe, and between August 01, 2017 and December 31, 2020
  • Patients (or next of kin/legal representative, if applicable) who provide written informed consent or non-opposition.

Exclusion criteria

  • N/A

Treatment and study plan

Primary outcomes

  1. Description of Age

    Time frame: At baseline

    Age will be assessed in years = neratinib initiation date - date of birth

  2. Description of Gender

    Time frame: At baseline

    Gender will be described in percentage of Male and Female among patients

  3. Description of BMI

    Time frame: At baseline

    BMI will be assessed in kg/m2

  4. Menopausal Status

    Time frame: At baseline

    Menopausal status will be described in percentage of Premenopausal, Perimenopausal, Postmenopausal, Surgical/other reason for amenorrhea

  5. Comorbidities

    Time frame: At baseline

    Comorbidities will be described in number and percentage of patients with at least one relevant comorbidity. Comorbidities were including but were not limited to: renal disease, liver disease, gastro-intestinal disorders, cardiovascular conditions, skin and subcutaneous disorders, diabetes (type I or II)

  6. HER2 Overexpression/Amplification Testing

    Time frame: At initial diagnosis

    HER2 overexpression/amplification testing will be assessed by Immunohistochemistry (IHC), Fluorescence in situ hybridization (FISH), Chromogenic in situ hybridization (CISH)

  7. Hormone Receptor Status

    Time frame: At initial diagnosis

    Hormone receptor status will be described in percentage of patients with Estrogen receptor (ER) positive, Progesterone receptor (PR) positive, ER and PR negative

  8. Primary Tumor Location

    Time frame: At initial diagnosis

    Primary tumor location will be described in percentage of patients with Left Breast cancer, Right Breast cancer

  9. Primary Tumor Histology

    Time frame: At initial diagnosis

    Primary tumor histology will be described in percentage of patients with Infiltrating ductal carcinoma, Infiltrating lobular carcinoma, Invasive carcinoma, Tubular, Other

  10. Histological Grade

    Time frame: At initial diagnosis

    Histological grade will be described in percentage of patients with G1 Well differentiated, G2 Moderately differentiated, G3 Poorly differentiated, G4 Undifferentiated

  11. Pathologic Stage (AJCC Classification) of Breast Cancer

    Time frame: At initial diagnosis

    Higher is the stage worse is the cancer.

    Stage is defined as:

    1A: tumor (T) up to 2 cm + not spread outside the breast; no lymph nodes (LN).1B: Small clusters of cancer cells (CC) (0.2-2 mm) are found in LN, or T in the breast is < 2 cm and small clusters of CC are found in LN. 2A: No T in the breast, but cancer is in 1-3 axillary LN or in LN near the breastbone or T is 2 cm or smaller + has spread to 1-3 axillary LN or LN near the breastbone, or T is > 2 cm and < 5 cm and not spread to LN.2B: T is > 2 cm and < 5 cm and has spread to 1-3 axillary LN or LN near the breastbone, or T is > 5 cm and not spread to the LN. 3A: no T in the breast or the T is any size; cancer is found in 4-9 axillary LN or LN near the breastbone, or T is larger than 5 cm and small clusters of CC found in LN. 3B: T has spread to chest wall or breast skin + may have spread to up to 9 axillary LN. 3C: Cancer has spread to ≥10 axillary LN, LN near the collarbone, or LN near breastbone

Sponsors and collaborators

Lead sponsor

Pierre Fabre Medicament

Industry

Collaborators

  • IQVIA Pty Ltd

Registry information

Official study title

A Retrospective Observational Study of Adult Patients With Early-stage HER2-positive Breast Cancer, Treated With Neratinib as Extended Adjuvant Therapy in the Context of the European Early Access Program (NEAR)

Acronym: NEAR

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 31, 2022
Registry last updated
Oct 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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