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)

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

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NCT06900647


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