NCT06876636

Zoledronic Acid Combined With EC-T for Triple-Negative Breast Cancer

Prospective, Open-Label, Single-Arm Clinical Study of Zoledronic Acid Combined With Neoadjuvant Chemotherapy (EC-T) in Patients With Early-Stage and Locally Advanced Triple-Negative Breast Cancer

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 99 (estimated)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Exploring the efficacy and safety of zoledronic acid combined with neoadjuvant chemotherapy (EC-T) in neoadjuvant treatment for early-stage or locally advanced triple-negative breast cancer, the trial protocol of zoledronic acid + liposomal doxorubicin + cyclophosphamide followed by zoledronic acid + nab-paclitaxel will provide a new effective therapeutic strategy for neoadjuvant treatment of triple-negative breast cancer patients and offer a novel treatment approach for triple-negative breast cancer.

Detailed description

This study is a prospective, open-label, single-arm clinical trial, planning to enroll 99 treatment-naïve patients with early-stage or locally advanced triple-negative breast cancer (clinical stage IIA-IIIC). The neoadjuvant treatment regimen consists of four cycles of chemotherapy with zoledronic acid + liposomal doxorubicin + cyclophosphamide, followed by four cycles of chemotherapy with zoledronic acid + nab-paclitaxel. The study aims to explore the efficacy and safety of zoledronic acid combined with neoadjuvant chemotherapy (EC-T) in the neoadjuvant treatment of early-stage or locally advanced triple-negative breast cancer.

Conditions

• Breast Cancer Metastatic

Interventions

Type	Name	Description
DRUG	Zoledronic Acid Combined with Neoadjuvant Chemotherapy (EC-T)	zoledronic acid + liposomal doxorubicin + cyclophosphamide followed by zoledronic acid + nab-paclitaxel Concurrent immunotherapy is permitted: pembrolizumab or toripalimab

Timeline

• Start date: 2025-03-10
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2025-03-14
• Last updated: 2025-07-29

Locations

1 site across 1 country: China