The Prognostic Impact of HER2 Expression in Non-Metastatic HER2-Positive Breast Cancer Treated With Dual HER2-Targeted Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Breast Cancer, HER2/CEP17 Ratio. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Primary outcome measures
- Disease-free survival based on HER2/CEP17 ratio [Time frame: From the date of pathological diagnosis to event with follow-up duration ≥3 months (unless recurrence or death occurred within 3 month).]
Eligibility criteria
Inclusion criteria
- Age ≥18 years.
- Pathologically confirmed primary breast cancer, clinical stage I-III (AJCC 8th Edition).
- HER2-positive status confirmed by FISH testing (per ASCO/CAP guidelines) with available HER2/CEP17 ratio.
- Received at least one dose of dual-target therapy (trastuzumab combined with pertuzumab) in the adjuvant or neoadjuvant setting.
- Underwent curative-intent surgery (mastectomy or breast-conserving surgery).
Exclusion criteria
- Presence of distant metastasis (Stage IV) or contralateral breast cancer at initial diagnosis.
- Previous anti-HER2 targeted therapy prior to dual-target treatment.
- Missing key clinical data (e.g., HER2 FISH results, treatment regimen, surgery date).
- Carcinoma in situ or occult breast cancer, non-primary breast cancer, or concurrent other malignancies.
- Loss to follow-up or follow-up duration <3 months (unless recurrence or death occurred within this period).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Department of Medical Oncology — Jinan
Identifiers
NCT: NCT07376174 · SDTHEC202601024