Bortezomib Plus Cisplatin in Recurrent or Metastatic Breast Cancer

Recruiting now · Phase 1

Conditions studied: Metastatic Breast Cancer, Recurrent Breast Cancer

In brief

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.

Key facts

Study ID

NCT06900647

Run by

Sun Yat-sen University

People needed

20

Starts

2025-01-01

Expected to finish

2028-06-30

Last updated by the study team

2025-04-02

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Sun Yat-Sen University Cancer Center — Guangzhou, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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