Breast Malignant Phyllodes Tumor
Conditions
Interventions
Experimental group:receive 4 mg Zoledronic acid intravenously once a month, for 2 years
Sponsors
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Eligibility
Sex/Gender
Female
Age
12 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Signed the informed consent; 2. Patients with histological diagnosed operable breast malignant phyllodes tumors without distant metastasis; 3. Has not received bisphosphonate treatment before; 4. The patient was diagnosed with breast malignant phyllodes tumors and received extensive resection or mastectomy: (extensive resection requires a surgical margin greater than or equal to 1cm, and the narrowing of the surgical margin increases the risk of local recurrence. However, if lumpectomy does not achieve a margin width greater than or equal to 1cm, it is not an absolute contraindication to mastectomy.); 5. Cardiac ultrasound indicated that the cardiac ejection fraction was in the normal range; 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; 7. Female aged between 12 and 70 years; 8. Women with negative pregnancy test and women of reproductive age accept contraception in the test; 9. Patients with good organ function and are not contraindicated with azolidronic acid and meet the following indicators: Hb >= 90 g/L; WBC >= 4.0 x 10^9/L; Platelet >= 100 x 10^9/L; Neutrophilic granulocytes >= 1.5×10^9/L; AST and ALT no more than 3 times the normal upper limit; Bilirubin no more than 1.5 times the normal upper limit; Serum creatinine than 30ml/min.
Exclusion criteria
Exclusion criteria: 1. Patients suffering from oral diseases (periodontal disease, exostosis, oral trauma, etc.); 2. Diabetes, or patients who need to use angiogenesis inhibitors and hormone therapy; 3. Complicated with other malignant tumors or have had other malignant tumors in the past 5 years, except for skin basal cell carcinoma or flat cell carcinoma that has been fully treated and controlled, and carcinoma in situ of the cervix; 4. Serious diseases combined with non-malignant tumors will affect the patient's compliance or put the patient in a dangerous state; 5. Accompanied by other anti-tumor therapies or participating in other clinical trials; 6. Patients diagnosed with metastatic breast phyllodes tumor; 7. Pregnant or breastfeeding women and women of reproductive age refuse to accept contraception; 8. Dementia, intellectual abnormality or any mental illness that interferes with the understanding of informed consent; 9. Severe liver dysfunction, child-pugh grade C, and or severe cardiac insufficiency, cardiac function grade III and above; 10. Patients with arrhythmia or taking anti-arrhythmia drugs; 11. Patients allergic to zoledronic acid and other bisphosphonates.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year disease-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| 5-year disease-free survival;3-year overall survival;5-year overall survival;incidence of adverse events of zoledronic acid; | — |
Countries
China
Contacts
Public ContactYan Nie
SunYat-Sen Memorial Hospital, SunYat-Sen University
Outcome results
None listed