RecruitingEarly Phase 1NCT04265872

Bortezomib Followed by Pembrolizumab and Cisplatin in metTNBC

Pilot Clinical Trial of Treatment With Bortezomib to Inhibit Homologous Recombination (HR) Followed by Pembrolizumab and Cisplatin in Patients With Chemotherapy-Pretreated Metastatic Triple Negative Breast Cancer


Sponsor

Baylor Research Institute

Enrollment

20 participants

Start Date

Oct 15, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

The hypothesis of this pilot trial is that administration of bortezomib will inhibit NHEJ in metastatic TNBC leading at the time of disease progression to metastases that are HR-deficient and sensitive to pembrolizumab and cisplatin therapy. The trial will include in depth analysis of the patients' TNBC genome and phosphoproteome to evaluate HR-proficiency and deficiency, and nuclear proteins that drive NHEJ, before and upon progression with bortezomib therapy.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of three drugs — bortezomib, pembrolizumab (immunotherapy), and cisplatin (chemotherapy) — for women with metastatic triple-negative breast cancer (TNBC), which is a type of breast cancer that lacks hormone receptors and is harder to treat. **You may be eligible if:** - You are a woman aged 18 or older with metastatic triple-negative breast cancer - You have previously received standard chemotherapy (anthracycline, cyclophosphamide, and taxane-based treatment) - You have not received more than 3 prior chemotherapy regimens for metastatic disease - You have measurable disease on scans and adequate organ function **You may NOT be eligible if:** - You have received more than 3 prior chemotherapy regimens for metastatic disease - You have significant heart, kidney, or other organ problems - You are pregnant or not using effective contraception - You have active autoimmune disease that required systemic treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBortezomib; pembrolizumab and cisplatin injections--bortezomib followed by pembro/cis

injection into a vein


Locations(1)

Baylor University Medical Center, Baylor Charles A Sammons Cancer Center

Dallas, Texas, United States

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NCT04265872


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