Official Title
HER-Seq: A Blood-based Screening Study to Identify Patients With HER2 Mutations for Enrollment Into Clinical Research Studies of Neratinib
Brief Title
HER-Seq: A Blood-based Screening Study to Identify Patients With HER2 Mutations for Enrollment Into Clinical Research Studies of Neratinib
Protocol ID
NCT03786107
Lead Sponsor
Puma Biotechnology, Inc.
Brief Summary
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.
Study Period
-
Enrollment Count
1,583 participants
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Filters
Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer
Metastatic Cervical Cancer
TERMINATED
ADULT
OLDER_ADULT