NCT07300215

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: The First Affiliated Hospital of Bengbu Medical University · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	individualized neoadjuvant treatment	For HR+/HER2+ breast cancer patients treated with TCbHP, after 2 cycles of treatment, they were classified according to the therapeutic effect into the effective group and the group without early response. The effective group continued to receive TCbHP treatment for another 4 cycles, while the group without early response changed to the neoadjuvant treatment regimen of trastuzumab dual-target combined with exemestane and palbociclib for 4 cycles. Evaluation methods: Early non-response is defined as the results of the examination after the end of the 2nd cycle of treatment meeting any of the following criteria: 1. MRI, ultrasound: PD/SD of lymph nodes or primary lesion, PR but tumor regression \< 50%; 2. Histological pathological examination:Changes in immunohistochemical molecular typing;The decrease in Ki-67 compared to the baseline is less than 20%;PIK3CA mutation.

Timeline

• Start date: 2025-12-20
• Primary completion: 2027-11-01
• Completion: 2027-11-01
• First posted: 2025-12-23
• Last updated: 2025-12-23