Bortezomib Followed by Pembrolizumab and Cisplatin in metTNBC

Part of paid clinical trials in Dallas, Texas.

Sponsor
Baylor Research Institute
Study ID
NCT04265872
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bortezomib; pembrolizumab and cisplatin injections--bortezomib followed by pembro/cis — DRUG
    injection into a vein

Study Details

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.

Key Dates

Start date
Oct 15, 2020
Status verified
Feb 2026
Primary completion
Dec 31, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Bortezomib followed by pembro/cis
    There is only one arm.

Primary Outcome Measure

Calculate objective response rate (CR+PR) associated with bortezomib followed at disease progression with pembrolizumab and cisplatin in metastatic TNBC [ Time Frame: 18 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Baylor University Medical Center, Baylor Charles A Sammons Cancer CenterDallasTexas75246
Joyce O'Shaughnessy, MD

Find similar trials in Dallas, TX

By condition
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By specialty
OncologyBreast oncologyWomen's health
By research site
Baylor University Medical Center, Baylor Charles A Sammons Cancer Center· Dallas, TX

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