Actively Recruiting
Bortezomib Followed by Pembrolizumab and Cisplatin in metTNBC
Led by Baylor Research Institute · Updated on 2026-02-12
20
Participants Needed
1
Research Sites
336 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Bortezomib Followed by Pembrolizumab and Cisplatin in metTNBC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients 18 years or older
- Diagnosed with metastatic triple-negative breast cancer previously treated with standard anthracycline, cyclophosphamide, and taxane chemotherapy (unless contraindicated)
- No more than 3 prior chemotherapy regimens for metastatic disease
- Have metastatic disease accessible for core needle biopsy or skin biopsy if necessary
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Adequate blood counts: ANC >1500/µL, platelets ≥100,000/µL, hemoglobin ≥9 g/dL
- Adequate liver function: AST and ALT ≤2.5 times upper limit of normal (ULN) or ≤5 times ULN if liver metastases present; total bilirubin ≤1.5 times ULN or direct bilirubin ≤ULN if total bilirubin >1.5 times ULN
- Adequate kidney function: serum creatinine ≤1.5 times ULN or creatinine clearance ≥30 mL/min
- Adequate coagulation function: INR or PT and aPTT ≤1.5 times ULN; if on anticoagulants, tests must be within therapeutic range
- History of treated brain metastases allowed if off steroids for two weeks and no progression
- Accessible for treatment and follow-up
- Able to understand the investigational nature and provide written informed consent
You will not qualify if you...
- Received a live vaccine within 30 days before starting study treatment (seasonal flu shots allowed except intranasal flu vaccine)
- Active autoimmune disease requiring systemic treatment within past 2 years
- Immunodeficiency or chronic systemic steroid therapy exceeding 10 mg prednisone daily within 7 days before treatment
- Known HIV infection
- Active hepatitis B or C infection
- History or current non-infectious pneumonitis requiring steroids
- Peripheral neuropathy grade 2 or higher
- Radiotherapy for metastatic disease completed less than 2 weeks before study start
- Active infection requiring systemic treatment
- Significant cardiovascular disease within past 6 months or severe heart failure
- Active tuberculosis
- Pregnant or breastfeeding; must use effective contraception until 3 months after last study drug
- Severe uncontrolled medical conditions affecting participation such as impaired lung function or severe liver disease
- Conditions or lab abnormalities that could interfere with study participation or results
- Systemic anti-cancer therapy including investigational agents within 4 weeks before study (except bortezomib on study)
- Any other investigational or anti-cancer treatments during study
- Any other active cancer
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Baylor University Medical Center, Baylor Charles A Sammons Cancer Center
Dallas, Texas, United States, 75246
Actively Recruiting
Research Team
P
Page Blas, MA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
1
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