Bortezomib Plus Cisplatin in Recurrent or Metastatic Breast Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18+
SponsorSun Yat-sen University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Sequential
Treatments tested in this trial
Bortezomib (B)
Drug1.3mg/m2, IV, D1, D4, D8 and D11, every 3 weeks
Cisplatin (CDDP)
Drug50mg/m2, IV, D1-3, every 3 weeks
Bortezomib (B)
Drug1.5mg/m2, IV, D1, D4, D8 and D11, every 3 weeks
Bortezomib (B)
Drug1.7mg/m2, IV, D1, D4, D8 and D11, every 3 weeks
Cisplatin (CDDP)
Drug70mg/m2, IV, D1-3, every 3 weeks
Treatment groups
20 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Dose level 1Experimental treatment 2 interventions
Group B: Dose level 2Experimental treatment 2 interventions
Group C: Dose level 3Experimental treatment 2 interventions
Group D: Dose level 4Experimental treatment 2 interventions
Group E: Dose level 5Experimental treatment 2 interventions
Group F: Dose level 6Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Dose-limiting toxicities (DLTs)
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.
Time frame
Within 28 days after the first dose.2
Maximum Tolerated Dose (MTD)
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.
Time frame
Within 28 days after the first dose.Secondary outcomes
1
Progression- free survival ( PFS )
PFS assessed by investigators according to RECIST version 1.1 criteria.
Time frame
Within approximately 48 months.2
Objective Response Rate (ORR)
ORR assessed by investigators according to RECIST version 1.1 criteria.
Time frame
Within approximately 48 months3
Disease Control Rate (DCR)
DCR assessed by investigators according to RECIST version 1.1 criteria.
Time frame
Within approximately 48 months4
Area Under the Curve (AUC)
The area under the plasma concentration-time curve (AUC) will be measured to evaluate the systemic exposure of bortezomib and cisplatin. Blood samples will be collected at specified time points to calculate AUC using non-compartmental analysis.
Time frame
Blood samples for PK analysis were collected within 60 minutes before dosing, at 0.5, 2, 6, 24, 72 hours, and on days 8, 15, and 22 after the start of dosing.Sponsors and contacts
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Source ClinicalTrials.gov