HER2-positive Breast CancerNCT07019272
Neratinib in Extended Adjuvant Treatment for HER2+ Early Breast Cancer With pCR But High-Risk Features: A Hebei Multi-Center Real-World Study
An observational study of HER2-positive Breast Cancer, run by Hebei Medical University Fourth Hospital.
Trial summary
Neratinib is an oral, irreversible pan-HER tyrosine kinase inhibitor. Current treatment guidelines recommend neratinib as an extended adjuvant therapy for HER2-positive breast cancer patients to further reduce the risk of recurrence. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HER2-positive Breast Cancer
- What is being tested?
- Neratinib (HKI-272)
- Type of treatment
- Pill or oral medicine
- How many people
- 170 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2025to 31 Oct 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Women only
- Adult, Older adult
Study population: This study focuses on HER2-positive early breast cancer (EBC) patients who achieved pathological complete response (pCR) following neoadjuvant therapy but present with high-risk features (such as initial clinical stage cT3/T4 tumors or node-positive disease). These patients must have completed standard adjuvant therapy (including trastuzumab-based regimens) and initiated neratinib as extended adjuvant treatment within 6 months after completing their standard therapy.
Who may be able to join
- Age ≥18 years, female
- Clinical stage ≥cT3 or ≥cN1, regardless of hormone receptor (HR) status
- HER2-positive: HER2 IHC 3+ or IHC 2+ with ISH+
- Achieved pathological complete response (pCR) after neoadjuvant therapy
- Completed 1 year of standard adjuvant therapy (including trastuzumab), with ≤6 months between the last adjuvant treatment and starting neratinib
- No evidence of recurrence or metastatic disease (confirmed by clinical/imaging exams after completing standard adjuvant therapy and before starting neratinib)
- Left ventricular ejection fraction (LVEF) ≥50%
- ECOG performance status 0-1
Who cannot join
- Hypersensitivity to any component of the investigational drug
- Inability to swallow oral medication
- Participation in another interventional clinical trial within 4 weeks before enrollment, or planned participation during this study
- Use of any investigational drug within 14 days prior to treatment initiation
- Concurrent chemotherapy, radiotherapy, immunotherapy, or biologic therapy for breast cancer
- Severe psychiatric disorders preventing compliance with informed consent, treatment, or follow-up procedures
- Pregnancy, lactation, or plans for pregnancy in the near future
- Other significant medical conditions or laboratory abnormalities that, in the investigator's judgment, make participation unsuitable
About this study
Official title: Efficacy and Safety of Neratinib as Extended Adjuvant Therapy in HER2-Positive Early Breast Cancer Patients Who Achieved pCR After Neoadjuvant Therapy But Have High-Risk Factors: A Multi-Center, Real-World Study From Hebei, China
Neratinib is an oral, irreversible pan-HER tyrosine kinase inhibitor. Current treatment guidelines recommend neratinib as an extended adjuvant therapy for HER2-positive breast cancer patients to further reduce the risk of recurrence.
Even when HER2-positive breast cancer patients achieve pathological complete response (pCR) after neoadjuvant therapy, those with high-risk factors (such as large tumors [cT3/T4] or lymph node-positive disease) still face a risk of cancer returning. However, there is limited data on the effectiveness and safety of neratinib in these patients.
This study aims to provide real-world evidence on how well neratinib works in high-risk HER2-positive breast cancer patients who achieved pCR, helping to improve treatment strategies for Chinese patients.
Read the detailed description
This study is a single-arm prospective study with historical controls as external comparators
- Conditions
- HER2-positive Breast Cancer
- Being tested
- Neratinib (HKI-272)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neratinib (HKI-272)Drug
Sequential neratinib extended adjuvant therapy will be initiated within 6 months after completing standard trastuzumab-based adjuvant therapy, continuing for 1 year.
As a real-world non-interventional study, treating physicians will determine neratinib regimens per the prescribing information and current clinical practice.
Neratinib Dosing:
Standard regimen: 240 mg (6 tablets) once daily with food for 1 year；
Dose escalation (to mitigate diarrhea, per latest CSCO Breast Cancer Guidelines and FDA labeling):
Week 1: 120 mg/day (days 1-7) Week 2: 160 mg/day (days 8-14) Week 3 onward: 240 mg/day (days 15-365)
What is being measured
The primary outcome is the main question the study is designed to answer.
Invasive Disease Free Survival (IDFS)
IDFS, as defined by the STEEP System, was measured from the date of treatment to the date of first occurrence of one of the following events: ipsilateral invasive breast tumor recurrence, regional invasive breast cancer recurrence, distant recurrence, contralateral invasive breast cancer, second primary non-breast invasive cancer, death attributable to any cause.
Measured: From Day 1 of treatment until 2 years after treatment completion
Secondary outcomes (8)
Disease Free Survival (DFS)
Disease-free survival is defined as the time from baseline until the first occurrence of DCIS or an iDFS event (an iDFS event including invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, or distant recurrence and death from any).
Measured: From Day 1 of treatment until 2 years after treatment completion
Overall Survival (OS)
OS was defined as the time from baseline to death due to any cause, censored at the last date known alive.
Measured: From Day 1 of treatment until 2 years after treatment completion
Distant Disease-free Survival (DDFS)
Distant disease-free survival time is defined as the time from baseline until the first occurrence of distant recurrence or death from any cause.
Measured: From Day 1 of treatment until 2 years after treatment completion
Time to distant recurrence
defined as time from baseline to the date of the first distant recurrence or death from breast cancer
Measured: From Day 1 of treatment until the first distant tumor recurrence or metastasis
Cumulative incidence of CNS recurrence
Measured: From Day 1 of treatment until 2 years after treatment completion
Incidence of grade ≥3 diarrhea
Measured: From consent to 28 days after last dose
Incidence and severity of other adverse events (AEs)
Measured: From consent to 28 days after last dose
Treatment patterns of patients
Measured: From Day 1 of treatment until last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start30 Jun 2025 (estimated)
- Primary completion31 Jul 2029 (estimated)
- Study completion31 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive Breast CancerStudies of the same condition, open and under way.
- More trials run by Hebei Medical University Fourth HospitalThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University Fourth Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07019272
- Sponsor's protocol ID
- 2025KY006
- Status last verified
- May 2025
- First submitted
- 17 May 2025
- Last updated
- 13 Jun 2025
- 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 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Neratinib as Extended Adjuvant Therapy in HER2-Positive Early Breast Cancer Patients Who Achieved pCR After Neoadjuvant Therapy But Have High-Risk Factors: A Multi-Center, Real-World Study From Hebei, China
- ClinicalTrials.gov ID
- NCT07019272
- Acronym / sponsor ID
- 2025KY006
- Conditions
- HER2-positive Breast Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Hebei Medical University Fourth HospitalUniversity, hospital or other
- Study start
- 30 Jun 2025 (estimated)
- Primary completion
- 31 Jul 2029 (estimated)
- Study completion
- 31 Oct 2030 (estimated)
- First posted
- 13 Jun 2025 (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.
Neratinib is an oral, irreversible pan-HER tyrosine kinase inhibitor. Current treatment guidelines recommend neratinib as an extended adjuvant therapy for HER2-positive breast cancer patients to further reduce the risk of recurrence.
Even when HER2-positive breast cancer patients achieve pathological complete response (pCR) after neoadjuvant therapy, those with high-risk factors (such as large tumors [cT3/T4] or lymph node-positive disease) still face a risk of cancer returning. However, there is limited data on the effectiveness and safety of neratinib in these patients.
This study aims to provide real-world evidence on how well neratinib works in high-risk HER2-positive breast cancer patients who achieved pCR, helping to improve treatment strategies for Chinese patients.
Detailed description
This study is a single-arm prospective study with historical controls as external comparators
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- This study focuses on HER2-positive early breast cancer (EBC) patients who achieved pathological complete response (pCR) following neoadjuvant therapy but present with high-risk features (such as initial clinical stage cT3/T4 tumors or node-positive disease). These patients must have completed standard adjuvant therapy (including trastuzumab-based regimens) and initiated neratinib as extended adjuvant treatment within 6 months after completing their standard therapy.
Key inclusion criteria (8 listed)
- Age ≥18 years, female
- Clinical stage ≥cT3 or ≥cN1, regardless of hormone receptor (HR) status
- HER2-positive: HER2 IHC 3+ or IHC 2+ with ISH+
- Achieved pathological complete response (pCR) after neoadjuvant therapy
- Completed 1 year of standard adjuvant therapy (including trastuzumab), with ≤6 months between the last adjuvant treatment and starting neratinib
Key exclusion criteria (8 listed)
- Hypersensitivity to any component of the investigational drug
- Inability to swallow oral medication
- Participation in another interventional clinical trial within 4 weeks before enrollment, or planned participation during this study
- Use of any investigational drug within 14 days prior to treatment initiation
- Concurrent chemotherapy, radiotherapy, immunotherapy, or biologic therapy for breast cancer
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 |
|---|---|---|
| Neratinib (HKI-272)Sequential neratinib extended adjuvant therapy will be initiated within 6 months after completing standard trastuzumab-based adjuvant therapy, continuing for 1 year. As a real-world non-interventional study, treating physicians will determine neratinib regimens per the prescribing information and current clinical practice. Neratinib Dosing: Standard regimen: 240 mg (6 tablets) once daily with food for 1 year； Dose escalation (to mitigate diarrhea, per latest CSCO Breast Cancer Guidelines and FDA labeling): Week 1: 120 mg/day (days 1-7) Week 2: 160 mg/day (days 8-14) Week 3 onward: 240 mg/day (days 15-365) | Drug | – |
Primary outcome
Invasive Disease Free Survival (IDFS)
Time frame: From Day 1 of treatment until 2 years after treatment completion
IDFS, as defined by the STEEP System, was measured from the date of treatment to the date of first occurrence of one of the following events: ipsilateral invasive breast tumor recurrence, regional invasive breast cancer recurrence, distant recurrence, contralateral invasive breast cancer, second primary non-breast invasive cancer, death attributable to any cause.
8 secondary outcomes
Disease Free Survival (DFS)
Time frame: From Day 1 of treatment until 2 years after treatment completion
Overall Survival (OS)
Time frame: From Day 1 of treatment until 2 years after treatment completion
Distant Disease-free Survival (DDFS)
Time frame: From Day 1 of treatment until 2 years after treatment completion
Time to distant recurrence
Time frame: From Day 1 of treatment until the first distant tumor recurrence or metastasis
Cumulative incidence of CNS recurrence
Time frame: From Day 1 of treatment until 2 years after treatment completion
Incidence of grade ≥3 diarrhea
Time frame: From consent to 28 days after last dose
Incidence and severity of other adverse events (AEs)
Time frame: From consent to 28 days after last dose
Treatment patterns of patients
Time frame: From Day 1 of treatment until last dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of HER2-positive Breast Cancer, run by Hebei Medical University Fourth Hospital.
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 8 inclusion and 8 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: opening soon, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Invasive Disease Free Survival (IDFS) (time frame: From Day 1 of treatment until 2 years after treatment completion). 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 13 Jun 2025.