Bortezomib Plus Cisplatin in Recurrent or Metastatic Breast Cancer

Prior treatment

• Currently receiving other anti-tumor treatments;

Other illness

• Patients with acute active hepatitis B or acute active hepatitis C;
• Any serious underlying disease, comorbidity and active infection
• History of epilepsy or epileptic-induced condition;
• Allergic to study drugs;

Age

• Patients diagnosed with other malignant tumors within 5 years, except for the following: surgically resected non-melanoma skin cancer, adequately treated cervical carcinoma in situ, surgically radically treated ductal carcinoma in situ, or malignant tumors diagnosed 2 years ago with no current evidence of disease and untreated ≤ 2 years before randomization;

Other

• Any of the following will be considered as meeting the exclusion criteria of the study:
• Patients who are pregnant or breastfeeding;
• Those with poor compliance or unable to undergo normal follow-up;
• The researcher determines other situations that may affect the conduct of the clinical study and the determination of the study results.

• Women aged 18 years and above with pathologically confirmed recurrent or metastatic advanced breast cancer ;
• The patient has tumor specimens (formalin-fixed, paraffin-embedded or fresh pre-treated recurrent tumor tissue);
• Patients who have failed standard treatment in the late stage;
• At least one measurable lesion;
• ECOG PS : 0-2 points;
• Estimated survival period ≥12 weeks;
• 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 reliable contraceptive measures, or have undergone a pregnancy test (serum or urine) within 7 days before enrollment, with a negative result, and are willing to use appropriate contraceptive methods during the trial and 8 weeks after the last administration of the trial drug.
  • 9\. The subjects voluntarily join this study, have good compliance, and cooperate with follow-up.