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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Disease-free survival based on HER2/CEP17 ratio
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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).
Arms & Interventions
HER2 FISH ultra
HER2/CEP17 FISH ratio in HER2-positive non-metastatic breast cancer
HER2 FISH normal
HER2/CEP17 FISH ratio in HER2-positive non-metastatic breast cancer
Outcomes
Primary Outcomes
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).
Defined as the period from the date of pathological diagnosis until the date of the first relapse, appearance of non-breast primary cancer, death with no signs or symptoms of recurrence or metast, or the last recorded follow-up ,whichever came first.
Secondary Outcomes
No secondary outcomes reported
Investigators
Fangchao Zheng, MD
Clinical associate professor
Shandong Cancer Hospital and Institute