Hormone Receptor-Positive, HER2-Negative Metastatic Breast CancerNCT03786107
HER-Seq: A Blood-based Screening Study to Identify Patients With HER2 Mutations for Enrollment Into Clinical Research Studies of Neratinib
An observational study of Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer and Metastatic Cervical Cancer, run by Puma Biotechnology, Inc. at 22 sites in 7 countries.
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) . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer, Metastatic Cervical Cancer
- What is being tested?
- Almac HER-Seq Assay
- How many people
- 1,583 participants
- Where
- 22 sitesin 7 countries
- Study dates
- 14 Mar 2019to 21 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with histologically-confirmed metastatic breast or metastatic cervical cancer
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
22 sites in 7 countries.
22 sites in 7 countries
Spain9 sites
Instituto Oncológico Dr. Rosell, Hospital Universitario Quirón Dexeus
Barcelona, 08028
Hospital Universitari Vall D'Hebron
Barcelona, 08035
Hospital Clinic de Barcelona
Barcelona, 08036
Hospital Clínico San Carlos
Madrid, 28040
START Madrid, Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040
Hospital Universitario Madrid Sanchinarro
Madrid, 28050
Hospital Universitario Quirónsalud Madrid
Pozuelo de Alarcón, Madrid, 28223
Fundación Instituto Valenciano de Oncológia
Valencia, 46009
Hospital Clínico Universitario de Valencia
Valencia, 46010
Ireland5 sites
Mater Misericordiae University Hospital, Institute for Cancer Research
Dublin, D07 R2WY
Beaumont Hospital, Cancer Clinical Trials & Research Unit
Dublin, D09 V2N0
St. Vincent's University Hospital
Elm Park, Dublin, D04 T6F4
University Hospital Waterford, Department of Medical Oncology
Waterford, X91 ER8E
Cork University Hospital
Wilton, Cork, T12 DC4A
Israel4 sites
Rabin Medical Center, Davidoff Cancer Center
Petah Tikva, Central District, 49100
Sheba Medical Center
Ramat Gan, 5262100
Kaplan Medical Center
Rehovot, Central District, 76101
Sourasky Medical Center
Tel Aviv, 64239
United States1 site
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, 15213
Italy1 site
Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"
Naples, 52-80131
About this study
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.
- Conditions
- Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer, Metastatic Cervical Cancer
- Being tested
- Almac HER-Seq Assay
- Keywords
- Circulating Tumor DNA, HER2, Genomic Screening, Metastatic, Breast, Cervical, ERBB2, Mutation, CDK4/6, HR Positive
- Medical subject headings
- Uterine Cervical Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Almac HER-Seq AssayDiagnostic test
whole blood sample analysis
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Eligible for Neratinib Treatment
Identification of participants with somatic, activating HER2 mutations who might qualify for enrollment into neratinib treatment protocols
Measured: From enrollment date to identification of HER2 positive mutation, assessed up to five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2018
- Study start14 Mar 2019
- Primary completion21 Jan 2021
- Study completion21 Jan 2021
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hormone Receptor-Positive, HER2-Negative Metastatic Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,583 participants (actual)
Sponsor and investigators
- Lead sponsor
- Puma Biotechnology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Senior Vice President Clinical Science and Pharmacology, Study director, Puma Biotechnology, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03786107
- Sponsor's protocol ID
- PUMA-NER-9501
- Status last verified
- May 2021
- First submitted
- 20 Dec 2018
- Last updated
- 19 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HER-Seq: A Blood-based Screening Study to Identify Patients With HER2 Mutations for Enrollment Into Clinical Research Studies of Neratinib
- ClinicalTrials.gov ID
- NCT03786107
- Acronym / sponsor ID
- PUMA-NER-9501
- Conditions
- Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer, Metastatic Cervical Cancer
- Keywords
- Circulating Tumor DNA, HER2, Genomic Screening, Metastatic, Breast, Cervical, ERBB2, Mutation
- Study type
- Observational
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 1,583 participants (actual)
- Lead sponsor
- Puma Biotechnology, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Mar 2019 (actual)
- Primary completion
- 21 Jan 2021 (actual)
- Study completion
- 21 Jan 2021 (actual)
- First posted
- 24 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with histologically-confirmed metastatic breast or metastatic cervical cancer
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Almac HER-Seq Assaywhole blood sample analysis | Diagnostic test | – |
Primary outcome
Number of Participants Eligible for Neratinib Treatment
Time frame: 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
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2021.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Senior Vice President Clinical Science and Pharmacology study director
Puma Biotechnology, Inc.
22 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer and Metastatic Cervical Cancer, run by Puma Biotechnology, Inc. at 22 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Spain, Ireland, Israel, United States, France and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Eligible for Neratinib Treatment (time frame: From enrollment date to identification of HER2 positive mutation, assessed up to five years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2021.