Study Stopped
The study was stopped early due to increased global access to genomic screening. It is no longer economical to continue with this particular single-gene screening protocol.
HER-Seq: A Blood-based Screening Study to Identify Patients With HER2 Mutations for Enrollment Into Clinical Research Studies of Neratinib
1 other identifier
observational
1,583
7 countries
22
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2019
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 20, 2018
CompletedFirst Posted
Study publicly available on registry
December 24, 2018
CompletedStudy Start
First participant enrolled
March 14, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 21, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 21, 2021
CompletedMay 19, 2021
May 1, 2021
1.9 years
December 20, 2018
May 17, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants Eligible for Neratinib Treatment
Identification of participants with somatic, activating HER2 mutations who might qualify for enrollment into neratinib treatment protocols
From enrollment date to identification of HER2 positive mutation, assessed up to five years
Interventions
whole blood sample analysis
Eligibility Criteria
Participants with histologically-confirmed metastatic breast or metastatic cervical cancer
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, 15213, United States
Institut Curie
Saint-Cloud, 92210, France
Cork University Hospital
Wilton, Cork, T12 DC4A, Ireland
St. Vincent's University Hospital
Elm Park, Dublin, D04 T6F4, Ireland
Mater Misericordiae University Hospital, Institute for Cancer Research
Dublin, D07 R2WY, Ireland
Beaumont Hospital, Cancer Clinical Trials & Research Unit
Dublin, D09 V2N0, Ireland
University Hospital Waterford, Department of Medical Oncology
Waterford, X91 ER8E, Ireland
Rabin Medical Center, Davidoff Cancer Center
Petah Tikva, Central District, 49100, Israel
Kaplan Medical Center
Rehovot, Central District, 76101, Israel
Sheba Medical Center
Ramat Gan, 5262100, Israel
Sourasky Medical Center
Tel Aviv, 64239, Israel
Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"
Napoli, 52-80131, Italy
Institute for Oncology and Radiology of Serbia
Belgrade, 11000, Serbia
Hospital Universitario Quirónsalud Madrid
Pozuelo de Alarcón, Madrid, 28223, Spain
Instituto Oncológico Dr. Rosell, Hospital Universitario Quirón Dexeus
Barcelona, 08028, Spain
Hospital Universitari Vall D'Hebron
Barcelona, 08035, Spain
Hospital Clinic de Barcelona
Barcelona, 08036, Spain
Hospital Clínico San Carlos
Madrid, 28040, Spain
START Madrid, Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040, Spain
Hospital Universitario Madrid Sanchinarro
Madrid, 28050, Spain
Fundación Instituto Valenciano de Oncológia
Valencia, 46009, Spain
Hospital Clínico Universitario de Valencia
Valencia, 46010, Spain
Biospecimen
Circulating tumor DNA from plasma will be collected from eligible participants. ERBB2 (HER2) gene exons 8 and 17-24 will be sequenced by next generation sequencing (NGS) at a central laboratory.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Senior Vice President Clinical Science and Pharmacology
Puma Biotechnology, Inc.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 20, 2018
First Posted
December 24, 2018
Study Start
March 14, 2019
Primary Completion
January 21, 2021
Study Completion
January 21, 2021
Last Updated
May 19, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Clinical study documents and clinical trial data may be requested by qualified researchers and study participants for studies that have been completed for at least 18 months, and for which the indication of the drug has been approved in the US and/or EU, as applicable. Requests will be accepted for up to 24 months after the criteria described in this section are met.
- Access Criteria
- Requestors must provide organizational contact information; a detailed research plan, including outcomes; timeline for completion of the research; qualifications of the research team; funding source; and potential conflicts of interest. Puma will not provide access to patient-level data if there is a reasonable likelihood that individual patients could be identified, or in cases where confidentiality or consent provisions prohibit transfer of data or information to third parties. Additionally, Puma will not disclose information that jeopardizes intellectual property rights or divulges confidential commercial information.
Puma Biotechnology is committed to sharing clinical trial data and information to help physicians and patients make informed treatment decisions, and to help qualified researchers advance scientific knowledge. In accordance with legal and regulatory requirements, Puma publishes study protocol information and clinical study results on clinical trial registries, including ClinicalTrials.gov and EU Clinical Trials Register. Puma also publishes information about clinical studies in peer-reviewed scientific journals and shares data in scientific meetings. Puma commits to safeguarding confidentiality and patient privacy throughout the clinical trial data and information sharing process. Any patient-level data will be anonymized to protect personally identifiable information. Qualified researchers and study participants may submit requests for other study documentation and clinical trial data to clinicaltrials@pumabiotechnology.com for consideration.