Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: NIL: NIL
Sponsors
AstraZeneca Pharma India Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Men or women, =18 years of age at study entry 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 criteria
Exclusion criteria: 1. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with IHC 1 positive or IHC 2 positive or ISH negative HER2 expression (HER2-low) and IHC greater than 0 or less than 1 positive or IHC null (no stain at all) based on historical IHC-stained FFPE slides previously identified among HER2-negative locally-advanced or mBC patients.Timepoint: Single Visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Distribution of patients demographic, clinicopathological characteristics, treatment patterns & duration in each LOT in locally-advanced or mBC disease at baseline, from the diagnosis of locally-advanced or mBC, concordance of HER2 IHC scores between historical & rescoring by local & or independent central laboratory post training, & HER2 low expression in HR-positive & HR-negative subgroups. Disease outcomes (time to first subsequent treatment, time to treatment discontinuation , overall survival, real-world progression-free survival, real-world objective response rate) will be assessed for overall study population & HER-2 subsets (HER2 low-IHC1 positive or IHC2 positive or ISH negative, HER2 IHC greater than 0 less than 1 positive, HER2 null, & HER2 zero-HER2 IHC greater than 0 less than 1 positive & HER2 null).The TFST, TTD, rwPFS & rwORR will also be assessed by each LOT.Timepoint: Single visit | — |
Countries
Argentina, Brazil, Chile, Dominican Republic, Hong Kong, India, Indonesia, Malaysia, Mexico, Panama, Philippines, Singapore, Thailand, Turkey, Viet Nam
Contacts
Public ContactJinu Johnson
AstraZeneca Pharma India Ltd
Outcome results
None listed