A Multicenter, Retrospective, Noninterventional Study to Determine the Prevalence of HER2-low, Clinical Characteristics, Treatment Patterns, and Associated Outcomes in Patients Previously Identified With HER2 negative Locally-advanced or Metastatic Breast Cancer Who Progressed on Systemic Anticancer Therapy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 2,700
- 试验地点
- 10
- 主要终点
- Proportion of patients with IHC 1 positive or IHC 2 positive or ISH negative HER2 expression (HER2-low) and
研究概览
简要总结
The current treatment landscape of HER2-negative/HER2-low metastatic breast cancer (mBC) comprises of endocrine therapy (ET; based on hormone receptor [HR] status), cyclindependent kinase (CDK)4/6 inhibitors, mammalian target of rapamycin (mTOR) inhibitors, phosphoinositide 3-kinase (PI3K) inhibitors in combination with ET and chemotherapy for patients with HER2-negative/HER2-low and HR-negative BC. There are limited targeted treatment options post progression on primary therapy for HER2-negative/HER2-low mBC.
The development of trastuzumab deruxtecan (T-DXd), an antibody-drug-conjugate, has opened up promising avenues for the treatment of HER2-low BC exceeding the efficacies of currently available treatment options.
Approximately, 60% of HER2-negative mBCs express low levels of HER2 constituting both HR-positive and HR-negative mBCs, and may significantly benefit from T-DXd with improved clinical and survival outcomes.
This noninterventional, multicenter, retrospective study has been proposed to estimate the prevalence, clinicopathological characteristics, treatment patterns, and clinical outcomes of HER2-low locally-advanced or mBC by accurate rescoring of archived IHC stained formalin-fixed paraffin-embedded (FFPE) slides for HER2 in patients previously identified as HER2-negative from emerging markets of international regions (non-US and non-European region) with largely unknown prevalence estimates of HER2 low mBCs.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Men or women, ≥18 years of age at study entry
- •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
- •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
- •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
- •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.
排除标准
- •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
- •Patients with historical HER2 status of IHC 2+/ISH+ or 3+, or HER2 amplified.
结局指标
主要结局
Proportion of patients with IHC 1 positive or IHC 2 positive or ISH negative HER2 expression (HER2-low) and
时间窗: Single Visit
IHC greater than 0 or less than 1 positive or IHC null (no stain at all) based on historical IHC-stained FFPE slides
时间窗: Single Visit
previously identified among HER2-negative locally-advanced or mBC patients.
时间窗: Single Visit
次要结局
- 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)