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Recruiting Phase 1

Bortezomib Plus Cisplatin in Recurrent or Metastatic Breast Cancer

NCT06900647 · tracked via the Priya Life Science China tracker
Phase
Phase 1
Started
2025-01-01
Last updated
2025-04-02

Condition(s) studied

Metastatic Breast CancerRecurrent Breast Cancer

Investigational drug(s) / intervention(s)

Bortezomib (B) →Cisplatin (CDDP) →Bortezomib (B) →Bortezomib (B) →Cisplatin (CDDP) →

Bortezomib (B): 1.3mg/m2, IV, D1, D4, D8 and D11, every 3 weeks

Cisplatin (CDDP): 50mg/m2, IV, D1-3, every 3 weeks

Bortezomib (B): 1.5mg/m2, IV, D1, D4, D8 and D11, every 3 weeks

Bortezomib (B): 1.7mg/m2, IV, D1, D4, D8 and D11, every 3 weeks

Cisplatin (CDDP): 70mg/m2, IV, D1-3, every 3 weeks

Study 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
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Dose-limiting toxicities (DLTs) — Within 28 days after the first dose.
    The DLT assessment period is from day 1 to day 21 of the subject's first dose plus 24 hours after the second dose, that is, 22 days. Each dose group must first enroll 3 subjects. If no DLT occurs in the first cycle (within 28 days after the first dose), the dose will be increased to the next cohort; if 1 subject develops DLT, 3 subjects will be added to the cohort, and if no DLT occurs in the last 3 subjects, the dose will be increased to the next dose. If 2 or more subjects in 3 or 6 subjects in a dose group develop DLT, the dose escalation will be stopped, and the previous dose of the dose will be the MTD. DLT is defined as a treatment-related adverse event of Grade 3 or higher, based on the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
  • Maximum Tolerated Dose (MTD) — Within 28 days after the first dose.
    If 2 or more subjects in 3 or 6 subjects in a dose group develop DLT, the dose escalation will be stopped , and the previous dose of the dose will be the MTD. If the MTD is not reached in this trial, the researchers will discuss whether to continue the subsequent escalation trial.

Trial sites (1)

FacilityCityRegionStatus
Sun Yat-Sen University Cancer Center Guangzhou Guangdong Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06900647 on ClinicalTrials.gov ↗ ← All trials in China