Bortezomib, Pembrolizumab, and Cisplatin for Metastatic Triple-Negative Breast Cancer

This study is testing a new treatment approach for women with metastatic triple-negative breast cancer (TNBC) that has already been treated with standard chemotherapy. The study will first give you bortezomib injections. If your cancer progresses, you will then receive pembrolizumab and cisplatin injections. Researchers believe bortezomib might make your cancer more sensitive to pembrolizumab and cisplatin. The main goal is to see how many patients have their tumors shrink or disappear (objective response rate) with this treatment, measured over 18 months. The study is looking for about 20 participants and its current status is unclear.

Study design
This is an interventional study with a planned enrollment of 20 women. It is testing a sequence of treatments: bortezomib followed by pembrolizumab and cisplatin.
What's involved
You will receive bortezomib injections until your disease progresses, then pembrolizumab and cisplatin injections for up to 6 cycles or until disease progression. Biopsies of a metastatic lesion will be taken at the start of the study and if your disease progresses on bortezomib.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome of objective response rate will be measured at 18 months.

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NCT04265872

Bortezomib Followed by Pembrolizumab and Cisplatin in metTNBC

Recruiting
EARLY_PHASE1Ages 18+InterventionalHealth services
Baylor Research Institute
~20 participants
Updated 2026-02-12 on ClinicalTrials.gov
What's tested:Bortezomib; pembrolizumab and cisplatin injections--bortezomib followed by pembro/cis

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Calculate objective response rate (CR+PR) associated with bortezomib followed at disease progression with pembrolizumab and cisplatin in metastatic TNBC
Measured over 18 months
Breast Cancer
1 sites across 1 states
Texas1
  • Joyce O'Shaughnessy, MD · PRINCIPAL_INVESTIGATOR · Texas Oncology

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  • Calculate objective response rate (CR+PR) associated with bortezomib followed at disease progression with pembrolizumab and cisplatin in metastatic TNBC18 months

    objective response rate will be calculated by defining the proportion of patients who have a complete or partial response to the study therapy, as determined by the treating physician