Status:
TERMINATED
HER-Seq: A Blood-based Screening Study to Identify Patients With HER2 Mutations for Enrollment Into Clinical Research Studies of Neratinib
Lead Sponsor:
Puma Biotechnology, Inc.
Conditions:
Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer
Metastatic Cervical Cancer
Eligibility:
All Genders
18+ years
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) ....
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 14 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 21 2021
Estimated Enrollment :
1583 Patients enrolled
Trial Details
Trial ID
NCT03786107
Start Date
March 14 2019
End Date
January 21 2021
Last Update
May 19 2021
Active Locations (22)
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1
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States, 15213
2
Institut Curie
Saint-Cloud, France, 92210
3
Cork University Hospital
Wilton, Cork, Ireland, T12 DC4A
4
St. Vincent's University Hospital
Elm Park, Dublin, Ireland, D04 T6F4