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The Prognostic Impact of HER2 Expression in Non-Metastatic HER2-Positive Breast Cancer Treated With Dual HER2-Targeted Therapy

Recruitingn/aAges 18 Years - anyFemaleShandong Cancer Hospital and Institute
NCT07376174 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Previous studies suggest that among patients receiving trastuzumab monotherapy, a HER2/CEP17 ratio \>7.0 (ultra-high expression) is associated with poorer disease-free survival (DFS). Dual-target therapy (trastuzumab + pertuzumab) has become the standard treatment for high-risk HER2-positive breast cancer; however, whether it can predict outcomes in patients with ultra-high HER2 expression remains unsupported by clinical data. To analyze the clinicopathological characteristics and prognostic relationship between the HER2 ultra-high expression group and the normal expression group in non-metastatic HER2-positive breast cancer patients who received dual-target therapy.

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📋 Eligibility rules (as published)
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).
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What it tests

  • Not listed
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Where

1 site
Department of Medical Oncology
Jinan, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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