Clinical trial NCT03786107: HER-Seq: A Blood-based Screening Study to Identify Patients With HER2 Mutations for Enrollment Into Clinical Research Studies of Neratinib
Official title: HER-Seq: A Blood-based Screening Study to Identify Patients With HER2 Mutations for Enrollment Into Clinical Research Studies of Neratinib
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer
Metastatic Cervical Cancer
Keywords: Circulating Tumor DNA
HER2
Genomic Screening
Metastatic
Breast
Cervical
ERBB2
Mutation
CDK4/6
HR Positive
Lead sponsor: Puma Biotechnology, Inc.
Sponsor class: INDUSTRY
First posted: 2018-12-24
Enrollment: 1583
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with histologically-confirmed metastatic breast or metastatic cervical cancer

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.


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

Primary outcomes:
measure: Number of Participants Eligible for Neratinib Treatment
timeFrame: From enrollment date to identification of HER2 positive mutation, assessed up to five years
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Magee-Womens Hospital of UPMC
state: Pennsylvania
city: Saint-Cloud
country: France
facility: Institut Curie
city: Wilton
country: Ireland
facility: Cork University Hospital
state: Cork
city: Elm Park
country: Ireland
facility: St. Vincent's University Hospital
state: Dublin
city: Dublin
country: Ireland
facility: Mater Misericordiae University Hospital, Institute for Cancer Research
city: Dublin
country: Ireland
facility: Beaumont Hospital, Cancer Clinical Trials & Research Unit
city: Waterford
country: Ireland
facility: University Hospital Waterford, Department of Medical Oncology
city: Petah tikva
country: Israel
facility: Rabin Medical Center, Davidoff Cancer Center
state: Central
city: Reẖovot
country: Israel
facility: Kaplan Medical Center
state: Central
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"
city: Belgrade
country: Serbia
facility: Institute for Oncology and Radiology of Serbia
city: Pozuelo de Alarcón
country: Spain
facility: Hospital Universitario Quirónsalud Madrid
state: Madrid
city: Barcelona
country: Spain
facility: Instituto Oncológico Dr. Rosell, Hospital Universitario Quirón Dexeus
city: Barcelona
country: Spain
facility: Hospital Universitari Vall D'Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: START Madrid, Hospital Universitario Fundacion Jimenez Diaz
city: Madrid
country: Spain
facility: Hospital Universitario Madrid Sanchinarro
city: Valencia
country: Spain
facility: Fundación Instituto Valenciano de Oncológia
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
Study officials:
affiliation: Puma Biotechnology, Inc.
name: Senior Vice President Clinical Science and Pharmacology
role: STUDY_DIRECTOR
References: