Breast CancerNCT05491057
Treatment Patterns of Neratinib in HER2+ EBC in China
An observational study of Breast Cancer, run by Pierre Fabre Medicament at 1 site in China.
Trial summary
This is a multicenter, open-label, single-arm, non-interventional study to investigate the treatment patterns of Neratinib in HER2-positive early-stage breast cancer in China Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Neratinib
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2022to 30 Jun 2026
- 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: Patients assigned extended adjuvant treatment with neratinib for 12 months for their HER2-positive, early-stage breast cancer.
Who may be able to join
- Signed written informed consent approved by the reviewing Ethics Committee (EC).
- Adult patients (≥18 years of age, no upper limit).
- Eligible to receive neratinib for extended adjuvant treatment as per prescribing information in China, diagnosed with HER2 overexpressing/amplified early-stage breast cancer regardless of hormone receptor (HR) status and clinical/radiological assessed to be negative for recurrences or metastatic disease.
Who cannot join
- Presence of any contraindication with regard to the neratinib treatment.
- Current or upcoming participation in an interventional clinical trial. (Investigational treatment within four weeks of enrolment).
Trial locations and contacts
1 site in 1 country.
China1 site
Medical Affair
Shanghai
Huanying Zhen, Master, 010-85347209, nlx-pms@pierre-fabre.com
Shujie Pei, Master, +86-13648686390, Shujie.pei@clinflash.com
About this study
Official title: A Multicenter, Open-label, Single-arm, Non-interventional Study to Investigate the Treatment Patterns of Nerlynx® (Neratinib) in HER2-positive Early-stage Breast Cancer in China
This is a multicenter, open-label, single-arm, non-interventional study to investigate the treatment patterns of Neratinib in HER2-positive early-stage breast cancer in China
- Conditions
- Breast Cancer
- Being tested
- Neratinib
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeratinibDrug
Neratinib standard dose 240 mg once daily for 1 year
| Study group | Role | What they receive |
|---|---|---|
| Neratinib extended ajuvant treatmeng for 1 year | Not described Receives: Drug: Neratinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Treatment
Median duration of extended adjuvant treatment with neratinib
Measured: 12 months of treatment
Treatment holds and permanent discontinuations time
Median treatment holds and permanent discontinuations time
Measured: 12 months of treatment
Secondary outcomes (11)
Patient demographics
% of patients with different demographic characteristics
Measured: Baseline
Patient characteristics
% of patients with different disease characteristics
Measured: Baseline
Time to treatment
Median time to treatment since completion of adjuvant regimen
Measured: Baseline
Prior adjuvant treatments
% of patients with different prior adjuvant treatments
Measured: Baseline
Dose adjustments
% of patients with dose adjustments
Measured: 12 months of treatment
Dose intensity
Absolute and relative dose intensity
Measured: 12 months of treatment
Concomitant medication
% of patients with different concomitant medications
Measured: 12 months of treatment
Incidence of AESI
Incidence of all grades of adverse events of special interest (AESI)
Measured: 12 months of treatment
Type of AESI
% of different type of all grades of adverse events of special interest (AESI)
Measured: 12 months of treatment
Severity of AESI
% of patients with adverse events by severity
Measured: 12 months of treatment
action taken for AESI
% of patients with action taken against adverse events
Measured: 12 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start30 Sep 2022 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Medicament
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05491057
- Sponsor's protocol ID
- PF008
- Status last verified
- Aug 2022
- First submitted
- 27 Jul 2022
- Last updated
- 8 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Single-arm, Non-interventional Study to Investigate the Treatment Patterns of Nerlynx® (Neratinib) in HER2-positive Early-stage Breast Cancer in China
- ClinicalTrials.gov ID
- NCT05491057
- Acronym / sponsor ID
- PF008
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Pierre Fabre MedicamentIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2022 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 8 Aug 2022 (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 multicenter, open-label, single-arm, non-interventional study to investigate the treatment patterns of Neratinib in HER2-positive early-stage breast cancer in China
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neratinib extended ajuvant treatmeng for 1 year | – | Drug: Neratinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients assigned extended adjuvant treatment with neratinib for 12 months for their HER2-positive, early-stage breast cancer.
Key inclusion criteria (3 listed)
- Signed written informed consent approved by the reviewing Ethics Committee (EC).
- Adult patients (≥18 years of age, no upper limit).
- Eligible to receive neratinib for extended adjuvant treatment as per prescribing information in China, diagnosed with HER2 overexpressing/amplified early-stage breast cancer regardless of hormone receptor (HR) status and clinical/radiological assessed to be negative for recurrences or metastatic disease.
Key exclusion criteria (2 listed)
- Presence of any contraindication with regard to the neratinib treatment.
- Current or upcoming participation in an interventional clinical trial. (Investigational treatment within four weeks of enrolment).
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 |
|---|---|---|
| NeratinibNeratinib standard dose 240 mg once daily for 1 year | Drug | Neratinib extended ajuvant treatmeng for 1 year |
Primary outcome
Duration of Treatment
Time frame: 12 months of treatment
Median duration of extended adjuvant treatment with neratinib
Treatment holds and permanent discontinuations time
Time frame: 12 months of treatment
Median treatment holds and permanent discontinuations time
11 secondary outcomes
Patient demographics
Time frame: Baseline
Patient characteristics
Time frame: Baseline
Time to treatment
Time frame: Baseline
Prior adjuvant treatments
Time frame: Baseline
Dose adjustments
Time frame: 12 months of treatment
Dose intensity
Time frame: 12 months of treatment
Concomitant medication
Time frame: 12 months of treatment
Incidence of AESI
Time frame: 12 months of treatment
Type of AESI
Time frame: 12 months of treatment
Severity of AESI
Time frame: 12 months of treatment
action taken for AESI
Time frame: 12 months of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2022.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Pierre Fabre Medicament at 1 site in China.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 8 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huanying Zhen, Master (+86010-8534-7209, nlx-pms@pierre-fabre.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of Treatment (time frame: 12 months of treatment). The study lists 2 primary outcomes in all. 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 8 Aug 2022.