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NCT Number: NCT07019272

Neratinib in Extended Adjuvant Treatment for HER2+ Early Breast Cancer With pCR But High-Risk Features: A Hebei Multi-Center Real-World Study

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.

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Key information

Conditions

HER2-positive Breast Cancer

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

About this study

This study is a single-arm prospective study with historical controls as external comparators

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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)

Primary outcomes

  1. 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.

Secondary outcomes

  1. Disease Free Survival (DFS)

    Time frame: From Day 1 of treatment until 2 years after treatment completion

    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).

  2. Overall Survival (OS)

    Time frame: From Day 1 of treatment until 2 years after treatment completion

    OS was defined as the time from baseline to death due to any cause, censored at the last date known alive.

  3. Distant Disease-free Survival (DDFS)

    Time frame: From Day 1 of treatment until 2 years after treatment completion

    Distant disease-free survival time is defined as the time from baseline until the first occurrence of distant recurrence or death from any cause.

  4. Time to distant recurrence

    Time frame: From Day 1 of treatment until the first distant tumor recurrence or metastasis

    defined as time from baseline to the date of the first distant recurrence or death from breast cancer

  5. Cumulative incidence of CNS recurrence

    Time frame: From Day 1 of treatment until 2 years after treatment completion

  6. Incidence of grade ≥3 diarrhea

    Time frame: From consent to 28 days after last dose

  7. Incidence and severity of other adverse events (AEs)

    Time frame: From consent to 28 days after last dose

  8. Treatment patterns of patients

    Time frame: From Day 1 of treatment until last dose

Sponsors and collaborators

Lead sponsor

Hebei Medical University Fourth Hospital

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2029
Study completion
2030
First posted
Jun 13, 2025
Registry last updated
Jun 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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