Bortezomib Plus Cisplatin in Recurrent or Metastatic Breast Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| Sun Yat-Sen University Cancer Center | Guangzhou | Guangdong | Recruiting |
More Sun Yat-sen University trials in China
Other trials for the same condition
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