Status:
RECRUITING
Bortezomib Plus Cisplatin in Recurrent or Metastatic Breast Cancer
Lead Sponsor:
Sun Yat-sen University
Conditions:
Metastatic Breast Cancer
Recurrent Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
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
- 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.
Exclusion
- Any of the following will be considered as meeting the exclusion criteria of the study:
- Patients with acute active hepatitis B or acute active hepatitis C;
- Any serious underlying disease, comorbidity and active infection
- Currently receiving other anti-tumor treatments;
- History of epilepsy or epileptic-induced condition;
- Patients who are pregnant or breastfeeding;
- Those with poor compliance or unable to undergo normal follow-up;
- Allergic to study drugs;
- 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;
- The researcher determines other situations that may affect the conduct of the clinical study and the determination of the study results.
Key Trial Info
Start Date :
January 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2028
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06900647
Start Date
January 1 2025
End Date
June 30 2028
Last Update
April 2 2025
Active Locations (1)
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1
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China, 510000