HER-Seq: A Blood-based Screening Study to Identify Patients With HER2 Mutations for Enrollment Into Clinical Research Studies of Neratinib

Metastatic Cervical Cancer Clinical Trial

Official title:

HER-Seq: A Blood-based Screening Study to Identify Patients With HER2 Mutations for Enrollment Into Clinical Research Studies of Neratinib

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03786107
• Other study ID #: PUMA-NER-9501
• Status: Terminated
• Start date: March 14, 2019
• Est. completion date: January 21, 2021

Study information

• Verified date: May 2021
• Source: Puma Biotechnology, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1583
• Est. completion date: January 21, 2021
• Est. primary completion date: January 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer
• Metastatic Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Diagnostic Test:
• Almac HER-Seq Assay
whole blood sample analysis

Locations

Country	Name	City	State
France	Institut Curie	Saint-Cloud
Ireland	Beaumont Hospital, Cancer Clinical Trials & Research Unit	Dublin
Ireland	Mater Misericordiae University Hospital, Institute for Cancer Research	Dublin
Ireland	St. Vincent's University Hospital	Elm Park	Dublin
Ireland	University Hospital Waterford, Department of Medical Oncology	Waterford
Ireland	Cork University Hospital	Wilton	Cork
Israel	Rabin Medical Center, Davidoff Cancer Center	Petah tikva	Central
Israel	Sheba Medical Center	Ramat Gan
Israel	Kaplan Medical Center	Re?ovot	Central
Israel	Sourasky Medical Center	Tel Aviv
Italy	Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"	Napoli
Serbia	Institute for Oncology and Radiology of Serbia	Belgrade
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital Universitari Vall D'Hebron	Barcelona
Spain	Instituto Oncológico Dr. Rosell, Hospital Universitario Quirón Dexeus	Barcelona
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital Universitario Madrid Sanchinarro	Madrid
Spain	START Madrid, Hospital Universitario Fundacion Jimenez Diaz	Madrid
Spain	Hospital Universitario Quirónsalud Madrid	Pozuelo de Alarcón	Madrid
Spain	Fundación Instituto Valenciano de Oncológia	Valencia
Spain	Hospital Clínico Universitario de Valencia	Valencia
United States	Magee-Womens Hospital of UPMC	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Puma Biotechnology, Inc.

Countries where clinical trial is conducted

United States,  France,  Ireland,  Israel,  Italy,  Serbia,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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