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

Terminated

• Conditions: Metastatic Cervical Cancer; Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer

• Registration Number: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-20
• Study First Submitted QC: 2018-12-20
• Study First Posted: 2018-12-24
• Study Start: 2019-03-14
• Primary Completion: 2021-01-21
• Study Completion: 2021-01-21
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-17
• Last Update Posted: 2021-05-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1583

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants Eligible for Neratinib Treatment	From enrollment date to identification of HER2 positive mutation, assessed up to five years	Identification of participants with somatic, activating HER2 mutations who might qualify for enrollment into neratinib treatment protocols

Trial Locations

Locations (22)

Institute for Oncology and Radiology of Serbia; 🇷🇸 Belgrade, Serbia

Magee-Womens Hospital of UPMC; 🇺🇸 Pittsburgh, Pennsylvania, United States

Institut Curie; 🇫🇷 Saint-Cloud, France

Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"; 🇮🇹 Napoli, Italy

Beaumont Hospital, Cancer Clinical Trials & Research Unit; 🇮🇪 Dublin, Ireland

University Hospital Waterford, Department of Medical Oncology; 🇮🇪 Waterford, Ireland

Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel

Mater Misericordiae University Hospital, Institute for Cancer Research; 🇮🇪 Dublin, Ireland

Hospital Clínico San Carlos; 🇪🇸 Madrid, Spain

Hospital Universitari Vall D'Hebron; 🇪🇸 Barcelona, Spain

Hospital Clinic de Barcelona; 🇪🇸 Barcelona, Spain

Cork University Hospital; 🇮🇪 Wilton, Cork, Ireland

St. Vincent's University Hospital; 🇮🇪 Elm Park, Dublin, Ireland

Kaplan Medical Center; 🇮🇱 Reẖovot, Central, Israel

Rabin Medical Center, Davidoff Cancer Center; 🇮🇱 Petah tikva, Central, Israel

Instituto Oncológico Dr. Rosell, Hospital Universitario Quirón Dexeus; 🇪🇸 Barcelona, Spain

Fundación Instituto Valenciano de Oncológia; 🇪🇸 Valencia, Spain

Sheba Medical Center; 🇮🇱 Ramat Gan, Israel

START Madrid, Hospital Universitario Fundacion Jimenez Diaz; 🇪🇸 Madrid, Spain

Hospital Universitario Quirónsalud Madrid; 🇪🇸 Pozuelo de Alarcón, Madrid, Spain

Hospital Universitario Madrid Sanchinarro; 🇪🇸 Madrid, Spain

Hospital Clínico Universitario de Valencia; 🇪🇸 Valencia, Spain