Bortezomib Plus Cisplatin in Recurrent or Metastatic Breast Cancer
Trial Parameters
Brief Summary
This a phase 1 study to evaluate the safety and preliminary efficacy of cisplatin combined with bortezomib in patients with recurrent or metastatic breast cancer.
Eligibility Criteria
Inclusion Criteria: 1. Women aged 18 years and above with pathologically confirmed recurrent or metastatic advanced breast cancer ; 2. The patient has tumor specimens (formalin-fixed, paraffin-embedded or fresh pre-treated recurrent tumor tissue); 3. Patients who have failed standard treatment in the late stage; 4. At least one measurable lesion; 5. ECOG PS : 0-2 points; 6. Estimated survival period ≥12 weeks; 7. The function level of major organs meets the following standards: 1\) The blood routine examination standards must meet: ANC ≥1.5×109/L, PLT ≥75×109/L, Hb ≥85g/L (no blood transfusion and blood products within 14 days, no use of G-CSF and other hematopoietic stimulating factors for correction) 2) Biochemical examinations must meet the following standards: TBIL \<1.5×ULN, ALT, AST \<2.5×ULN, ALT, AST \<5×ULN for patients with liver metastasis, BUN and Cr ≤1×ULN or endogenous creatinine clearance ≥50ml/min (Cockcroft-Gault formula); 8. Women of childbearing age must have taken r