A study to see the prevalence of HER2 low, clinical characteristics, treatment patterns, and outcomes in patients with HER2 negative locally advanced or metastatic breast cancer who progressed on systemic anticancer therapy.
- Conditions
- Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
- Registration Number
- CTRI/2024/03/063553
- Lead Sponsor
- AstraZeneca Pharma India Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients with IHC 1 positive or IHC 2 positive or ISH negative HER2 expression (HER2-low) and <br/ ><br>IHC greater than 0 or less than 1 positive or IHC null (no stain at all) based on historical IHC-stained FFPE slides <br/ ><br>previously identified among HER2-negative locally-advanced or mBC patients.Timepoint: Single Visit
- Secondary Outcome Measures
Name Time Method 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. <br/ ><br>Disease outcomes (time to first subsequent treatment, time to treatment <br/ ><br>discontinuation , overall survival, real-world progression-free survival, <br/ ><br>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 <br/ ><br>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