Status:
ACTIVE_NOT_RECRUITING
Zoledronic Acid Combined With EC-T for Triple-Negative Breast Cancer
Lead Sponsor:
Xijing Hospital
Conditions:
Breast Cancer Metastatic
Eligibility:
FEMALE
18-75 years
Phase:
NA
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...
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 II...
Eligibility Criteria
Inclusion
- 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.
- 10、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.
- 11、Voluntarily participate in this study, sign the informed consent form, have good compliance, and are willing to cooperate with follow-up visits
Exclusion
- 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;
- Having severe concomitant diseases or other conditions that would interfere with planned treatment, or any other circumstances deemed by the investigator to make the patient unsuitable for participation in this study.
Key Trial Info
Start Date :
March 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT06876636
Start Date
March 10 2025
End Date
December 1 2025
Last Update
July 29 2025
Active Locations (1)
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1
Xijing hospital
Xi'an, Shannxi, China, 710032