Clinical Trial

An Exploratory Study on Individualized Neoadjuvant Treatment Regimens for Early HR+/HER2+ Breast Cancer

Not Yet Recruiting Phase 2
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Summary
HR+/HER2+ breast cancer belongs to a special type of tumor with dual-channel signal activation. However, in clinical treatment, the preferred approach is usually the inhibition of the HER2 signaling pathway. Therefore, the non-pCR rate after neoadjuvant therapy is relatively high (about 60%). To optimize the neoadjuvant treatment strategy for HR+/HER2+ breast cancer, increase the pCR rate of neoadjuvant treatment, and improve the prognosis of patients, our research group intends to conduct a prospective clinical and translational study. By observing the clinical efficacy and changes in biomarkers, individualized treatment for HR+/HER2+ breast cancer will be carried out. Patients who respond well to HER2-targeted therapy will be identified early, and for those without early relief, targeted combined dual-channel inhibition therapy with endocrine treatment will be adopted. The effectiveness and safety of the individualized neoadjuvant treatment strategy for HR+/HER2+ breast cancer patients will be evaluated. In addition, this study aims to focus on the neoadjuvant chemotherapy mechanism of HR+/HER2+ breast cancer, and combine the establishment and validation of effective disease models to provide theoretical basis and experimental support for achieving precise treatment and clinical transformation.
Trial Details
NCT Number NCT07300215
Lead Sponsor The First Affiliated Hospital of Bengbu Medical University
Conditions Breast Cancer
Enrollment 60 participants
Start Date 2025-12-20
Primary Completion 2027-11-01 (estimated)
Study Completion 2027-11-01 (estimated)
Updated on ClinicalTrials.gov 2025-12-23