Trial · NCT06900647
Bortezomib Plus Cisplatin in Recurrent or Metastatic Breast Cancer
NCT06900647, Phase 1, Recruiting, Sun Yat-sen University
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Bortezomib Plus Cisplatin in Recurrent or Metastatic Breast Cancer. Trials, record NCT06900647. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06900647
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Bortezomib Plus Cisplatin in Recurrent or Metastatic Breast Cancer
- NCT number
- NCT06900647
- Status
- Recruiting
- Phases
- Phase 1
- Enrollment
- 20 participants, estimated
- Lead sponsor
- Sun Yat-sen University
- Conditions
- Metastatic Breast Cancer, Recurrent Breast Cancer
- Interventions
- Bortezomib (B), Cisplatin (CDDP), Bortezomib (B), Bortezomib (B), Cisplatin (CDDP)
- First posted
- 2025-03-28
- Last updated
- 2025-04-02
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Primary | 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. |
| Secondary | Progression- free survival ( PFS ) | Within approximately 48 months. | PFS assessed by investigators according to RECIST version 1.1 criteria. |
| Secondary | Objective Response Rate (ORR) | Within approximately 48 months | ORR assessed by investigators according to RECIST version 1.1 criteria. |
| Secondary | Disease Control Rate (DCR) | Within approximately 48 months | DCR assessed by investigators according to RECIST version 1.1 criteria. |
| Secondary | Area Under the Curve (AUC) | 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. |
| Secondary | Maximum Plasma Concentration (Cmax) | 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. |
| Secondary | Time to Maximum Plasma Concentration (Tmax) | 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. |
| Secondary | Half-Life (T1/2) | 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%. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers17
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06900647
GET https://conductscience.org/api/trials/v1/NCT06900647/registered