To hear about similar clinical trials, please enter your email below
Trial Title:
A Retrospective Observational Study of Patients With Early-stage HER2-positive Breast Cancer, Treated With Neratinib
NCT ID:
NCT05599334
Condition:
Breast Cancer
Adjuvant Therapy
HER2-positive Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
HER2-positive Breast Cancer
Adjuvant therapy
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Retrospective
Summary:
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.
Criteria for eligibility:
Study pop:
The study population will include all patients with early-stage HER2+ breast cancer
having received at least one dose of neratinib as an extended adjuvant therapy in the
context of the EAP in Europe between August 01, 2017 and December 31, 2020.
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Clinique Saint-Luc Bouge
Address:
City:
Bouge
Zip:
5004
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Lionel Leclere
Phone:
+3281209020
Email:
lionel.leclere@slbo.be
Contact backup:
Last name:
Pauline Delescaille
Phone:
+32 81 20 95 32
Email:
pauline.delescaille@slbo.be
Start date:
July 8, 2022
Completion date:
February 2023
Lead sponsor:
Agency:
Pierre Fabre Medicament
Agency class:
Industry
Collaborator:
Agency:
Iqvia Pty Ltd
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/NCT05599334
