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

NCT06876636 | Active Not Recruiting

• 1 other identifier: KY20252004-C-1
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer Metastatic

Keywords

Zoledronic Acid; Neoadjuvant Chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 6 months

Secondary Outcomes (4)

• Objective Response Rate (ORR)

  up to 6 months

• Clinical Benefit Rate (CBR)

  up to 6 months

• Disease-Free Survival (DFS)

  up to 6 years

• Overall Survival (OS)

  up to 6 years

Study Arms (1)

Zoledronic Acid

EXPERIMENTAL

Zoledronic acid 4 mg on Day 1 every 3 weeks (q3w) plus liposomal doxorubicin 35 mg/m² on Day 1 q3w plus cyclophosphamide 600 mg/m² on Day 1 q3w, for four cycles. Concurrent immunotherapy is permitted: pembrolizumab 200 mg on Day 1 q3w or toripalimab 240 mg on Day 1 q3w. Thereafter, zoledronic acid 4 mg on Day 1 q3w plus nab-paclitaxel 260 mg/m² on Day 1 q3w for another four cycles. If immunotherapy was given during the first four cycles, it may be continued for the latter four cycles. A total of eight chemotherapy cycles are planned, with allowance for multiple drug interruptions due to adverse events.

Drug: Zoledronic Acid Combined with Neoadjuvant Chemotherapy (EC-T)

Interventions

Zoledronic Acid Combined with Neoadjuvant Chemotherapy (EC-T) DRUG

zoledronic acid + liposomal doxorubicin + cyclophosphamide followed by zoledronic acid + nab-paclitaxel Concurrent immunotherapy is permitted: pembrolizumab or toripalimab

Also known as: Zoledronic Acid

Zoledronic Acid

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients aged ≥18 years and ≤75 years who have not received prior treatment;
• ECOG score of 0 to 1;
• Her-2 (0), Her-2 (1+), Her-2 (2+) must test negative by ISH (in situ hybridization).
• Hormone receptor status: ER (Estrogen Receptor) \<1%, PR (Progesterone Receptor) \<1%;
• The functional levels of major organs must meet the following requirements (no blood transfusion within 2 weeks prior to screening, no use of white blood cell or platelet-raising drugs):
• Complete blood count： Absolute neutrophil count (ANC) ≥1.5×10\^9/L; Platelet count (PLT) ≥90×10\^9/L; Hemoglobin (Hb) ≥90 g/L;
• Blood chemistry Total bilirubin (TBIL) ≤ upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5×ULN; Alkaline phosphatase ≤2.5×ULN; Blood urea nitrogen (BUN) and creatinine (Cr) ≤1.5×ULN;
• Echocardiogram Left ventricular ejection fraction (LVEF) ≥55%; 9、12-lead ECG QTc interval corrected by Fridericia's method (QTcF) \<470 msec.
• 、For premenopausal or surgically unsterilized female patients: agree to abstain from sexual intercourse or use effective contraceptive methods during the treatment period and for at least 7 months after the last administration of study treatment.
• 、Voluntarily participate in this study, sign the informed consent form, have good compliance, and are willing to cooperate with follow-up visits

You may not qualify if:

• Stage IV (metastatic) breast cancer;
• Inflammatory breast cancer;
• A history of receiving anti-cancer treatment or radiotherapy for any malignant tumor, excluding curative treatments for in situ cervical cancer, basal cell carcinoma, or squamous cell carcinoma, etc.;
• Concurrently participating in other clinical trials involving anti-cancer therapies, including endocrine therapy, bisphosphonate therapy, or immunotherapy;
• Having undergone significant non-breast cancer related surgical procedures within 4 weeks prior to enrollment, or not having fully recovered from such procedures;
• Severe cardiac disease or conditions, including but not limited to the following:
• A confirmed history of heart failure or systolic dysfunction (LVEF \<50%);
• High-risk uncontrolled arrhythmias, such as atrial tachycardia, resting heart rate \>100 bpm, significant ventricular arrhythmias (e.g., ventricular tachycardia), or higher-grade atrioventricular block (i.e., Mobitz Type II second-degree atrioventricular block or third-degree atrioventricular block);
• Angina requiring anti-anginal medication;
• Clinically significant valvular heart disease;
• ECG showing transmural myocardial infarction;
• Poorly controlled hypertension (systolic blood pressure \>180 mmHg and/or diastolic blood pressure \>100 mmHg);
• Inability to swallow, intestinal obstruction, or other factors affecting drug intake and absorption;
• Known history of allergies to the components of the study medication: a history of immunodeficiency, including positive HIV tests, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
• Pregnant or nursing women, women of childbearing potential with a positive baseline pregnancy test, or women of reproductive age who are unwilling to use effective contraceptive measures throughout the trial period and for 7 months after the last administration of study medication;

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijing hospital

Xi'an, Shannxi, 710032, China

Location

MeSH Terms

Interventions

Neoadjuvant Therapy; Zoledronic Acid

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: March 14, 2025
• Study Start: March 10, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 29, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)