Bortezomib Plus Cisplatin in Recurrent or Metastatic Breast Cancer (BOCIS)

March 27, 2025 updated by: Shi Yanxia, Sun Yat-sen University

Phase I Study to Evaluate the Safety and Preliminary Efficacy of Bortezomib Combined With Cisplatin in Patients With Recurrent or Metastatic Breast Cancer

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • Sun yat-sen University Cancer Center
        • Principal Investigator:
          • Yanxia Shi, Doctor
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose level 1
In this dose level, all subjects will receive a dose of 1.3m/m2 bortezomib combined with a dose of 50mg/m2 cisplatin.
Drug: Bortezomib (B)
1.3mg/m2, IV, D1, D4, D8 and D11, every 3 weeks
Drug: Cisplatin (CDDP)
50mg/m2, IV, D1-3, every 3 weeks
Drug: Bortezomib (B)
1.5mg/m2, IV, D1, D4, D8 and D11, every 3 weeks
Drug: Bortezomib (B)
1.7mg/m2, IV, D1, D4, D8 and D11, every 3 weeks
Drug: Cisplatin (CDDP)
70mg/m2, IV, D1-3, every 3 weeks
Experimental: Dose level 2
In this dose level, all subjects will receive a dose of 1.5m/m2 bortezomib combined with a dose of 50mg/m2 cisplatin.
Drug: Bortezomib (B)
1.3mg/m2, IV, D1, D4, D8 and D11, every 3 weeks
Drug: Cisplatin (CDDP)
50mg/m2, IV, D1-3, every 3 weeks
Drug: Bortezomib (B)
1.5mg/m2, IV, D1, D4, D8 and D11, every 3 weeks
Drug: Bortezomib (B)
1.7mg/m2, IV, D1, D4, D8 and D11, every 3 weeks
Drug: Cisplatin (CDDP)
70mg/m2, IV, D1-3, every 3 weeks
Experimental: Dose level 3
In this dose level, all subjects will receive a dose of 1.7m/m2 bortezomib combined with a dose of 50mg/m2 cisplatin.
Drug: Bortezomib (B)
1.3mg/m2, IV, D1, D4, D8 and D11, every 3 weeks
Drug: Cisplatin (CDDP)
50mg/m2, IV, D1-3, every 3 weeks
Drug: Bortezomib (B)
1.5mg/m2, IV, D1, D4, D8 and D11, every 3 weeks
Drug: Bortezomib (B)
1.7mg/m2, IV, D1, D4, D8 and D11, every 3 weeks
Drug: Cisplatin (CDDP)
70mg/m2, IV, D1-3, every 3 weeks
Experimental: Dose level 4
In this dose level, all subjects will receive a dose of 1.3m/m2 bortezomib combined with a dose of 75mg/m2 cisplatin.
Drug: Bortezomib (B)
1.3mg/m2, IV, D1, D4, D8 and D11, every 3 weeks
Drug: Cisplatin (CDDP)
50mg/m2, IV, D1-3, every 3 weeks
Drug: Bortezomib (B)
1.5mg/m2, IV, D1, D4, D8 and D11, every 3 weeks
Drug: Bortezomib (B)
1.7mg/m2, IV, D1, D4, D8 and D11, every 3 weeks
Drug: Cisplatin (CDDP)
70mg/m2, IV, D1-3, every 3 weeks
Experimental: Dose level 5
In this dose level, all subjects will receive a dose of 1.5m/m2 bortezomib combined with a dose of 75mg/m2 cisplatin.
Drug: Bortezomib (B)
1.3mg/m2, IV, D1, D4, D8 and D11, every 3 weeks
Drug: Cisplatin (CDDP)
50mg/m2, IV, D1-3, every 3 weeks
Drug: Bortezomib (B)
1.5mg/m2, IV, D1, D4, D8 and D11, every 3 weeks
Drug: Bortezomib (B)
1.7mg/m2, IV, D1, D4, D8 and D11, every 3 weeks
Drug: Cisplatin (CDDP)
70mg/m2, IV, D1-3, every 3 weeks
Experimental: Dose level 6
In this dose level, all subjects will receive a dose of 1.7m/m2 bortezomib combined with a dose of 75mg/m2 cisplatin.
Drug: Bortezomib (B)
1.3mg/m2, IV, D1, D4, D8 and D11, every 3 weeks
Drug: Cisplatin (CDDP)
50mg/m2, IV, D1-3, every 3 weeks
Drug: Bortezomib (B)
1.5mg/m2, IV, D1, D4, D8 and D11, every 3 weeks
Drug: Bortezomib (B)
1.7mg/m2, IV, D1, D4, D8 and D11, every 3 weeks
Drug: Cisplatin (CDDP)
70mg/m2, IV, D1-3, every 3 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose-limiting toxicities (DLTs)
Time Frame: 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.
Within 28 days after the first dose.
Maximum Tolerated Dose (MTD)
Time Frame: 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.
Within 28 days after the first dose.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression- free survival ( PFS )
Time Frame: Within approximately 48 months.
PFS assessed by investigators according to RECIST version 1.1 criteria.
Within approximately 48 months.
Objective Response Rate (ORR)
Time Frame: Within approximately 48 months
ORR assessed by investigators according to RECIST version 1.1 criteria.
Within approximately 48 months
Disease Control Rate (DCR)
Time Frame: Within approximately 48 months
DCR assessed by investigators according to RECIST version 1.1 criteria.
Within approximately 48 months
Area Under the Curve (AUC)
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.
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.
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.
Time to Maximum Plasma Concentration (Tmax)
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.
The time to reach the maximum plasma concentration (Tmax) will be assessed for bortezomib and cisplatin. Tmax will be determined directly from the plasma concentration-time data.
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.
Half-Life (T1/2)
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.
The terminal elimination half-life (T1/2) of bortezomib and cisplatin will be calculated using non-compartmental analysis. T1/2 represents the time required for the plasma concentration of the drug to decrease by 50%.
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.
Maximum Plasma Concentration (Cmax)
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.
The maximum observed plasma concentration (Cmax) of bortezomib and cisplatin will be determined from the collected blood samples. Cmax reflects the peak concentration of the drug in plasma after administration.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: Yan-xia Shi, Doctor, Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2028

Study Registration Dates

First Submitted

March 16, 2025

First Submitted That Met QC Criteria

March 21, 2025

First Posted (Actual)

March 28, 2025

Study Record Updates

Last Update Posted (Actual)

April 2, 2025

Last Update Submitted That Met QC Criteria

March 27, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-FXY-300

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared due to ethical and privacy concerns.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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