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

Not yet recruiting

• Conditions: HER2-positive Breast Cancer

• Registration Number: NCT07019272
• Lead Sponsor: Hebei Medical University Fourth Hospital

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

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-17
• Study First Submitted QC: 2025-06-04
• Last Update Submitted: 2025-06-04
• Study First Posted: 2025-06-13
• Last Update Posted: 2025-06-13
• Study Start: 2025-06-30
• Primary Completion: 2029-07-31
• Study Completion: 2030-10-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 170

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Invasive Disease Free Survival (IDFS)	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 Outcome Measures

Name	Time	Method
Disease Free Survival (DFS)	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).
Overall Survival (OS)	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.
Distant Disease-free Survival (DDFS)	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.
Time to distant recurrence	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
Cumulative incidence of CNS recurrence	From Day 1 of treatment until 2 years after treatment completion
Incidence of grade ≥3 diarrhea	From consent to 28 days after last dose
Incidence and severity of other adverse events (AEs)	From consent to 28 days after last dose
Treatment patterns of patients	From Day 1 of treatment until last dose