HER-Seq: A Blood-based Screening Study to Identify Patients With HER2 Mutations for Enrollment Into Clinical Research Studies of Neratinib
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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.
Condition or disease
Hormone Receptor-Positive, HER2-Negative Metastatic Breast CancerMetastatic Cervical Cancer
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Participants with histologically-confirmed metastatic breast or metastatic cervical cancer
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
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