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

NCT ID: NCT07019272

Last Updated: 2025-06-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 170 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-06-30
• Study Completion Date: 2030-10-31

Brief 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.

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

Conditions

HER2-positive Breast Cancer

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

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)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age ≥18 years, female

2. Clinical stage ≥cT3 or ≥cN1, regardless of hormone receptor (HR) status

3. HER2-positive: HER2 IHC 3+ or IHC 2+ with ISH+

4. Achieved pathological complete response (pCR) after neoadjuvant therapy

5. Completed 1 year of standard adjuvant therapy (including trastuzumab), with ≤6 months between the last adjuvant treatment and starting neratinib

6. No evidence of recurrence or metastatic disease (confirmed by clinical/imaging exams after completing standard adjuvant therapy and before starting neratinib)

7. Left ventricular ejection fraction (LVEF) ≥50%

8. ECOG performance status 0-1

Exclusion Criteria

1. Hypersensitivity to any component of the investigational drug

2. Inability to swallow oral medication

3. Participation in another interventional clinical trial within 4 weeks before enrollment, or planned participation during this study

4. Use of any investigational drug within 14 days prior to treatment initiation

5. Concurrent chemotherapy, radiotherapy, immunotherapy, or biologic therapy for breast cancer

6. Severe psychiatric disorders preventing compliance with informed consent, treatment, or follow-up procedures

7. Pregnancy, lactation, or plans for pregnancy in the near future

8. Other significant medical conditions or laboratory abnormalities that, in the investigator's judgment, make participation unsuitable

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hebei Medical University Fourth Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

2025KY006

Identifier Type: -

Identifier Source: org_study_id