How very high HER2 levels affect outcomes after dual HER2 therapy in early breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Department of Medical Oncology
  Jinan, Shandong, China Recruiting

Study contacts

• Study coordinator: Fangchao Zheng, MD
• Email: sgzhfch@yeah.net
• Phone: 86-67627005

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.