Status:
COMPLETED
NIS Study Determining Prevalence of HER2-low in Metastatic Breast Cancer Patients
Lead Sponsor:
AstraZeneca
Conditions:
HER2-negative
Eligibility:
All Genders
18+ years
Brief Summary
This noninterventional, multicenter,retrospective study has been proposed to estimate the prevalence, clinicopathological characteristics,treatment patterns and clinical outcomes of human epidermal gr...
Detailed Description
Multicenter, noninterventional, retrospective study, aimed to determine the prevalence of HER2-low and HER2\>0\<1+ by rescoring of archived IHC-stained FFPE slides for HER2 in patients previously iden...
Eligibility Criteria
Inclusion
- Men or women, ≥18 years of age 2. Provision of informed consent by the patient or next of kin/legal representative (for deceased patients at study entry, unless a waiver was granted) according to local regulations 3. Must have a histological or cytological confirmed previous diagnosis as HER2-negative (IHC zero, 1+, 2+/ISH-) locally-advanced or mBC between 01 January 2019 and 31 December 2022, regardless of HR status 4. Must have progressed on any systemic anticancer therapy (eg, ET, chemotherapy, CDK4/6 inhibitor, targeted therapies other than anti-HER2, or immunotherapy) in the metastatic setting with the availability of at least 12 months of follow-up data (from the index date) in the medical records at the participating site, unless patient died within the first 12 months of diagnosis a) The HR positive patients will be considered eligible for the study if they have received ET as adjuvant therapy in the early BC setting and progressed within 24 months, this scenario will be considered as progression on systematic treatment in the advanced or metastatic setting 5. Must have historical IHC-stained FFPE tissue from locally-advanced or mBC slides for HER2 in an acceptable quality to allow for accurate rescoring of HER2 expression -
Exclusion
- Have a history of other malignancies, other than basal cell carcinoma of the skin and squamous cell carcinoma of the skin until 3 years prior to diagnosis of locally-advanced or mBC 2. Patients with historical HER2 status of IHC 2+/ISH+ or 3+, or HER2 amplified
- \-
Key Trial Info
Start Date :
April 23 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 19 2025
Estimated Enrollment :
1151 Patients enrolled
Trial Details
Trial ID
NCT06131424
Start Date
April 23 2024
End Date
May 19 2025
Last Update
September 18 2025
Active Locations (31)
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1
Research Site
Rosario, Argentina
2
Research Site
São Paulo, Brazil
3
Research Site
Santo Domingo, Dominican Republic
4
Research Site
Hong Kong, Hong Kong