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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
99
zoledronic acid + liposomal doxorubicin + cyclophosphamide followed by zoledronic acid + nab-paclitaxel Concurrent immunotherapy is permitted: pembrolizumab or toripalimab
Xijing hospital
Xi'an, Shannxi, China
Pathological Complete Response (pCR) rate
pCR is defined as the absence of invasive tumor cells in the breast and axillary lymph nodes after primary tumor resection (ypT0/is ypN0) as assessed microscopically.
Time frame: up to 6 months
Objective Response Rate (ORR)
The proportion of patients evaluated as having a Complete Response (CR) or Partial Response (PR) according to RECIST version 1.1.
Time frame: up to 6 months
Clinical Benefit Rate (CBR)
The proportion of patients evaluated as having a CR, PR, or Stable Disease (SD) lasting at least 6 months according to RECIST version 1.1.
Time frame: up to 6 months
Disease-Free Survival (DFS)
The time from enrollment to the first occurrence of recurrent disease, which includes ipsilateral or contralateral recurrence of breast cancer, local or regional recurrence, distant metastasis, and death from any cause.
Time frame: up to 6 years
Overall Survival (OS)
The time from enrollment to death from any cause.
Time frame: up to 6 years
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