A Multicenter, Retrospective, Noninterventional Study to Determine thePrevalence of HER2-low, Clinical Characteristics, Treatment Patterns, andAssociated Outcomes in Patients Previously Identified With HER2 negativeLocally-advanced or Metastatic Breast Cancer Who Progressed on Systemic Anticancer Therapy - iRetroBC-HER2L Study

AstraZeneca Pharma India Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年8月19日

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•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
•2. Patients with historical HER2 status of IHC 2+/ISH+ or 3+, or HER2 amplified

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