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

Sponsor

Puma Biotechnology, Inc. (Industry)

Overall Status

Terminated

CT.gov ID

NCT03786107

Collaborator

(none)

1,583

Enrollment

Locations

22.3

Actual Duration (Months)

Patients Per Site

3.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer Metastatic Cervical Cancer	Diagnostic Test: Almac HER-Seq Assay

Study Design

Study Type:

Observational

Actual Enrollment :

1583 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 14, 2019

Actual Primary Completion Date :

Jan 21, 2021

Actual Study Completion Date :

Jan 21, 2021

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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
5	Mater Misericordiae University Hospital, Institute for Cancer Research	Dublin		Ireland	D07 R2WY
6	Beaumont Hospital, Cancer Clinical Trials & Research Unit	Dublin		Ireland	D09 V2N0
7	University Hospital Waterford, Department of Medical Oncology	Waterford		Ireland	X91 ER8E
8	Rabin Medical Center, Davidoff Cancer Center	Petah tikva	Central	Israel	49100
9	Kaplan Medical Center	Reẖovot	Central	Israel	76101
10	Sheba Medical Center	Ramat Gan		Israel	5262100
11	Sourasky Medical Center	Tel Aviv		Israel	64239
12	Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"	Napoli		Italy	52-80131
13	Institute for Oncology and Radiology of Serbia	Belgrade		Serbia	11000
14	Hospital Universitario Quirónsalud Madrid	Pozuelo de Alarcón	Madrid	Spain	28223
15	Instituto Oncológico Dr. Rosell, Hospital Universitario Quirón Dexeus	Barcelona		Spain	08028
16	Hospital Universitari Vall D'Hebron	Barcelona		Spain	08035
17	Hospital Clinic de Barcelona	Barcelona		Spain	08036
18	Hospital Clínico San Carlos	Madrid		Spain	28040
19	START Madrid, Hospital Universitario Fundacion Jimenez Diaz	Madrid		Spain	28040
20	Hospital Universitario Madrid Sanchinarro	Madrid		Spain	28050
21	Fundación Instituto Valenciano de Oncológia	Valencia		Spain	46009
22	Hospital Clínico Universitario de Valencia	Valencia		Spain	46010