HER-Seq: A Blood-based Screening Study to Identify Patients With HER2 Mutations for Enrollment Into Clinical Research Studies of Neratinib
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1,583
- 试验地点
- 22
- 主要终点
- Number of Participants Eligible for Neratinib Treatment
研究概览
简要总结
This is a multi-center, observational genomic screening protocol to identify participants whose tumors harbor somatic mutations in the ERBB2 (HER2) gene, as measured in circulating tumor DNA (ctDNA) . Participants with histologically confirmed, hormone receptor positive, HER-2 negative, metastatic breast cancer (MBC) or metastatic cervical cancer (MCC) are eligible for screening at 6 months intervals, or if disease progression is suspected/confirmed. Blood samples will be collected from eligible participants and ctDNA will be extracted and sequenced at a central laboratory, using a HER2-targeted next generation sequencing (NGS) test. A certified molecular test report will be issued from the central laboratory and provided to the investigators and the study sponsor. Participants who are identified with HER2 mutations by this screening protocol will subsequently have access to an appropriate neratinib treatment protocol, pending medical eligibility.
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 who are ≥18 years old at signing of informed consent
- •Eastern Cooperative Oncology Group (ECOG) status of 0 to 2
- •Provide written informed consent to participate in the study and for circulating tumor DNA screening
- •Must be able to provide blood sample(s) for HER2 mutation testing
- •Participants with imaging or histologically confirmed, HR-positive, HER2-negative MBC who are presently receiving or have received CDK4/6 inhibitor as a prior therapy in any setting, or participants with imaging or histologically confirmed metastatic cervical cancer
- •At least one measurable lesion, as defined by RECIST v1.1
排除标准
- •Participants with breast cancer with known HER2-positive or HER2-amplified tumors
- •Participants with breast cancer with HR-negative tumors
- •Participants who have received HER2-directed TKI
- •Participants with previously documented somatic KRAS activating mutation
结局指标
主要结局
Number of Participants Eligible for Neratinib Treatment
时间窗: From enrollment date to identification of HER2 positive mutation, assessed up to five years
Identification of participants with somatic, activating HER2 mutations who might qualify for enrollment into neratinib treatment protocols
次要结局
未报告次要终点