NCT07376174 The Prognostic Impact of HER2 Expression in Non-Metastatic HER2-Positive Breast Cancer Treated With Dual HER2-Targeted Therapy
| NCT ID | NCT07376174 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shandong Cancer Hospital and Institute |
| Condition | Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2026-01-10 |
| Primary Completion | 2026-06-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2026-01-10 with a primary completion date of 2026-06-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07376174 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07376174 currently recruiting?
Yes, NCT07376174 is actively recruiting participants. Contact the research team at sgzhfch@yeah.net for enrollment information.
Where is the NCT07376174 trial being conducted?
This trial is being conducted at Jinan, China.
Who is sponsoring the NCT07376174 clinical trial?
NCT07376174 is sponsored by Shandong Cancer Hospital and Institute. The trial plans to enroll 300 participants.
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