Breast cancer
Conditions
Interventions
Experimental group:Surgery combined with radiofrequency ablation + Systemic anti-tumor therapy + bone repair therapy for breast cancer (4mg Zoleic acid vgtt q.m. / 6mg ibandronic acid vgtt q.m.)
Control group:Systemic anti-tumor therapy + bone repair therapy for breast cancer (4mg Zoleic acid vgtt q.m. / 6mg ibandronic acid vgtt q.m.)
Sponsors
Shanghai Tenth People's Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Female patients =18 years old and =75 years old; 2. ECOG score 0-1; 3. Primary infiltrating breast lesions and lymph nodes must meet the following conditions at the same time: 1) Invasive breast cancer confirmed by histology; 2) Have received radical resection of breast cancer or breast-conserving surgery: patients who have received breast-conserving surgery must be confirmed by pathological examination that there is no residual invasive cancer and ductal carcinoma in situ at the resection margin; the resection margin allows residual lobular carcinoma in situ 3) No recurrent and metastatic disease other than bone occurred after the operation; 4. Bone metastasis is diagnosed by X-ray, CT, MRI or ECT, and there are measurable lesions that meet the RECIST 1.1 standard or only bone metastases, the number of metastatic lesions is =5, and the maximum metastatic lesion diameter is =3cm; 5. If you have received neoadjuvant therapy in the past, you must complete at least 4 cycles of treatment and the medication plan must include chemotherapy; 6. Known hormone receptor status (ER and PgR); 7. The functional level of major organs must meet the following requirements (no blood transfusion, no use of excessive white blood cell or platelet-increasing drugs within 2 weeks before screening): 1) Blood routine ? Neutrophils (ANC) = 1.5×109/L; ? Platelet count (PLT) = 90×109/L; ? Hemoglobin (Hb) = 90 g/L; 2) Blood biochemistry ? Total bilirubin (TBIL)=1.5×upper limit of normal (ULN); ? Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)=1.5×ULN; ? Alkaline phosphatase=2.5×ULN; ? Urea or urea nitrogen (BUN) and creatinine (Cr)= 1.5×ULN; 3) 12-lead ECG: QT interval (QTcF) corrected by Fridericia method <470 msec. 8. Volunteer to join the study, sign an informed consent form, have good compliance and are willing to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Recurrent and metastatic disease other than bone appears after surgery; 2. Bone metastasis is diagnosed by X-ray, CT, MRI or ECT, and there are measurable lesions that meet the RECIST 1.1 standard or only bone metastases, the number of metastatic lesions>5, and the largest metastatic lesion diameter>3cm; 3. Bone metastases have symptoms of nerve root or spinal cord compression, or the posterior wall of the vertebral body is severely damaged; 4. The history of any malignant tumor other than breast cancer in the past 5 years, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or squamous cell carcinoma; 5. At the same time receive anti-tumor therapy in other clinical trials, including endocrine therapy, bisphosphonate therapy or immunotherapy; 6. Have received major surgical operations not related to breast cancer within 4 weeks before randomization, or the patient has not fully recovered from such surgical operations; 7. Many underlying diseases, severe heart disease or discomfort, intolerance of surgery, including but not limited to the following diseases: 1) History of diagnosis of heart failure or systolic dysfunction (LVEF 180 mmHg and/or diastolic blood pressure> 100 mmHg) 8. Abnormal clotting time, with bleeding tendency; 9. A history of diagnosed neurological or mental disorders, including patients with involuntary behavior or mental illness; 10. Female patients during pregnancy and lactation, female patients with fertility and a positive baseline pregnancy test; 11. Suffer from serious concomitant diseases or other comorbid diseases that will interfere with planned treatment, including infectious diseases with active infections (including but not limited to hepatitis B, active hepatitis C, active tuberculosis, active syphilis, etc.), Or the investigator believes that the patient is not suitable for any other situation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;tumor control probability;Adverse Event; | — |
Countries
China
Contacts
Public ContactLin Fang
Shanghai Tenth People's Hospital
Outcome results
None listed