Actively Recruiting
The Prognostic Impact of HER2 Expression in Non-Metastatic HER2-Positive Breast Cancer Treated With Dual HER2-Targeted Therapy
Led by Shandong Cancer Hospital and Institute · Updated on 2026-01-29
300
Participants Needed
1
Research Sites
23 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Prognostic Impact of HER2 Expression in Non-Metastatic HER2-Positive Breast Cancer Treated With Dual HER2-Targeted Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Pathologically confirmed primary breast cancer, clinical stage I to III
- HER2-positive status confirmed by FISH testing with available HER2/CEP17 ratio
- Received at least one dose of dual-target therapy (trastuzumab with pertuzumab) in adjuvant or neoadjuvant setting
- Underwent curative-intent surgery (mastectomy or breast-conserving surgery)
You will not qualify if you...
- Presence of distant metastasis (Stage IV) or contralateral breast cancer at initial diagnosis
- Previous anti-HER2 targeted therapy before dual-target treatment
- Missing key clinical data such as HER2 FISH results, treatment regimen, or surgery date
- Carcinoma in situ, occult breast cancer, non-primary breast cancer, or concurrent other malignancies
- Loss to follow-up or follow-up duration less than 3 months unless recurrence or death occurred within this period
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of Medical Oncology
Jinan, Shandong, China
Actively Recruiting
Research Team
F
Fangchao Zheng, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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