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

Prior treatment

• 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.;
• Having undergone significant non-breast cancer related surgical procedures within 4 weeks prior to enrollment, or not having fully recovered from such procedures;
• Inability to swallow, intestinal obstruction, or other factors affecting drug intake and absorption;
• 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.

Other illness

• Stage IV (metastatic) breast cancer;
• Inflammatory breast cancer;
• Concurrently participating in other clinical trials involving anti-cancer therapies, including endocrine therapy, bisphosphonate therapy, or immunotherapy;
• 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;

Lab values

• 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);

Age

• 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;

• 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