RecruitingPhase 1NCT06900647
Bortezomib Plus Cisplatin in Recurrent or Metastatic Breast Cancer
Phase I Study to Evaluate the Safety and Preliminary Efficacy of Bortezomib Combined With Cisplatin in Patients With Recurrent or Metastatic Breast Cancer
Sponsor
Sun Yat-sen University
Enrollment
20 participants
Start Date
Jan 1, 2025
Study Type
INTERVENTIONAL
Conditions
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
Sex: FEMALEMin Age: 18 Years
Inclusion Criteria9
- 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:
- \) 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.
- \. The subjects voluntarily join this study, have good compliance, and cooperate with follow-up.
Exclusion Criteria9
- 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.
Interventions
DRUGBortezomib (B)
1.3mg/m2, IV, D1, D4, D8 and D11, every 3 weeks
DRUGCisplatin (CDDP)
50mg/m2, IV, D1-3, every 3 weeks
DRUGBortezomib (B)
1.5mg/m2, IV, D1, D4, D8 and D11, every 3 weeks
DRUGBortezomib (B)
1.7mg/m2, IV, D1, D4, D8 and D11, every 3 weeks
DRUGCisplatin (CDDP)
70mg/m2, IV, D1-3, every 3 weeks
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06900647
Related Trials
A Study of Disitamab Vedotin With Other Anticancer Drugs in Solid Tumors
NCT06157892139 locations
Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer
NCT066493311 location
Improving Survival for Metastatic Lobular Breast Cancer (PLUMB Registry)
NCT059645044 locations
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
NCT0342400545 locations
Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer
NCT0708576735 locations