Recruiting

Bortezomib Plus Cisplatin in Recurrent or Metastatic Breast Cancer

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.

ClinicalTrials.gov IDNCT06900647
PhasePHASE1
Enrollment20
SponsorSun Yat-sen University
Age18 Years
SexFEMALE
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Conditions studied

Metastatic Breast Cancer, Recurrent Breast Cancer

About this study

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.

Interventions

Primary outcomes

Eligibility information

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 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. Exclusion Criteria: Any of the following will be considered as meeting the exclusion criteria of the study: 1. Patients with acute active hepatitis B or acute active hepatitis C; 2. Any serious underlying disease, comorbidity and active infection 3. Currently receiving other anti-tumor treatments; 4. History of epilepsy or epileptic-induced condition; 5. Patients who are pregnant or breastfeeding; 6. Those with poor compliance or unable to undergo normal follow-up; 7. Allergic to study drugs; 8. 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; 9. The researcher determines other situations that may affect the conduct of the clinical study and the determination of the study results.

Study locations

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.