How very high HER2 levels affect outcomes after dual HER2 therapy in early breast cancer
A Multicenter Retrospective Cohort Study Protocol on the Prognostic Impact of HER2 Expression in Non-Metastatic HER2-Positive Breast Cancer Treated With Dual HER2-Targeted Therapy
This project will see if people with very high HER2 levels (HER2/CEP17 ratio >7) do better or worse after getting trastuzumab plus pertuzumab for early-stage HER2-positive breast cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Shandong Cancer Hospital and Institute Academic / other |
| Drugs / interventions | trastuzumab, pertuzumab |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT07376174 on ClinicalTrials.gov |
What this trial studies
This is an observational cohort analysis of adults with pathologically confirmed stage I–III HER2-positive breast cancer who received at least one dose of dual HER2-targeted therapy (trastuzumab plus pertuzumab) and curative-intent surgery. Patients are grouped by HER2/CEP17 ratio (ultra-high >7 versus typical range) based on FISH testing and their clinicopathological features and outcomes are compared. The primary focus is disease-free survival and recurrence patterns after neoadjuvant or adjuvant dual-target therapy. Cases with distant metastasis at diagnosis, missing key data, prior anti-HER2 therapy before the dual regimen, or concurrent other malignancies are excluded.
Who should consider this trial
Good fit: Adults (≥18) with primary stage I–III HER2-positive breast cancer confirmed by FISH with an available HER2/CEP17 ratio who received trastuzumab plus pertuzumab and underwent curative-intent surgery are the ideal candidates.
Not a fit: Patients with stage IV disease at diagnosis, contralateral or non-primary cancers, missing HER2 FISH data, prior anti-HER2 therapy before the dual regimen, or inadequate follow-up are unlikely to be eligible or benefit from the analysis.
Why it matters
Potential benefit: If successful, the findings could help doctors better predict prognosis and tailor follow-up or treatment intensity for patients with ultra-high HER2 expression.
How similar studies have performed: Prior reports linked ultra-high HER2/CEP17 ratios (>7) to worse disease-free survival with trastuzumab alone, but there is limited clinical evidence on whether adding pertuzumab changes that risk.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥18 years. 2. Pathologically confirmed primary breast cancer, clinical stage I-III (AJCC 8th Edition). 3. HER2-positive status confirmed by FISH testing (per ASCO/CAP guidelines) with available HER2/CEP17 ratio. 4. Received at least one dose of dual-target therapy (trastuzumab combined with pertuzumab) in the adjuvant or neoadjuvant setting. 5. Underwent curative-intent surgery (mastectomy or breast-conserving surgery). Exclusion Criteria: 1. Presence of distant metastasis (Stage IV) or contralateral breast cancer at initial diagnosis. 2. Previous anti-HER2 targeted therapy prior to dual-target treatment. 3. Missing key clinical data (e.g., HER2 FISH results, treatment regimen, surgery date). 4. Carcinoma in situ or occult breast cancer, non-primary breast cancer, or concurrent other malignancies. 5. Loss to follow-up or follow-up duration \<3 months (unless recurrence or death occurred within this period).
Where this trial is running
Jinan, Shandong
- Department of Medical Oncology — Jinan, Shandong, China (Recruiting)
Study contacts
- Study coordinator: Fangchao Zheng, MD
- Email: sgzhfch@yeah.net
- Phone: 86-67627005
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.