NCT06551116招募中不适用
QuantifyHER: Quantitative Immunofluorescence and/or RT-qPCR for Measuring HER2 in HER2-low Metastatic Breast Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 65
- 主要终点
- Real-World Objective Response Rate
研究概览
简要总结
This study will assess whether a quantitative, HER2 assay can accurately and reliably discriminate between responders and non-responders among patients with HER2 IHCI+ metastatic breast cancer who are receiving T-Dxd.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women and men age > 18 years
- •Metastatic breast cancer, histologically- confirmed. Any estrogen receptor (ER) status is allowed. ER status will be determined by local laboratory assessment utilizing ASCO/CAP guidelines.
- •Primary and/or metastatic tumor with 1+ level of expression of HER2 by immunohistochemistry as determined by local laboratory assessment utilizing ASCO/CAP guidelines.
- •Measurable disease by cross-sectional imaging at the start of treatment. Patients with measurable bone-only disease or active brain metastases are eligible.
- •Archival tissue available for biomarker assessment. One specimen should be the most recent metastatic biopsy. If HER2 1+ status was determined on a different specimen (either primary or metastatic tissue), that specimen is also required. Samples obtained from bone metastases that were processed via decalcification methods are not eligible.
- •Intention to initiate therapy with T-DXd (Enhertu) at FDA-approved dose and schedule as next line of therapy. If T-DXd was already initiated, patients must be registered within 30 days of initiation.
- •Ability to provide informed consent
排除标准
- •Concurrent Her2-overexpressing metastatic breast cancer (as confirmed by a metastatic biopsy with IHC 3+ or IHC 2+ with FISH amplified as per standard ASCO/CAP guidelines)
结局指标
主要结局
Real-World Objective Response Rate
时间窗: from date of first dose of T-DXd to date of last dose of T-DXd for each. Up to 100 months
Association between quantitative HER2 expression (as a continuous variable) and real-world objective response rate
次要结局
- Association between combined mRNA + QIF and real-world Objective Response Rate(from date of first dose of T-DXd to date of last dose of T-DXd for each. Up to 100 months)
- Real-World Progression Free Survival(from date of first dose of T-DXd to date of last dose of T-DXd for each.Up to 100 months)
- Threshold for HER2 QIF and/or mRNA levels(from date of first dose of T-DXd to date of last dose of T-DXd for each. Up to 100 months)
- Real-World Progression Free Survival and Objective Response Rate by estrogen receptor expression(from date of first dose of T-DXd to date of last dose of T-DXd for each. Up to 100 months)
研究者
研究点 (65)
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