OncoMatch/Clinical Trials/NCT04265872
Bortezomib Followed by Pembrolizumab and Cisplatin in metTNBC
Is NCT04265872 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies Bortezomib; pembrolizumab and cisplatin injections--bortezomib followed by pembro/cis for breast cancer.
Treatment: Bortezomib; pembrolizumab and cisplatin injections--bortezomib followed by pembro/cis — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 negative (<=10% tumor nuclei immunoreactivity or 'ER Low Positive' as defined by the updated ASCO/CAP guidelines 2020)
TNBC defined as ER-negative tumors with < or = 10% tumor nuclei immunoreactivity, or 'ER Low Positive' as defined by the updated ASCO/CAP guidelines 2020
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anthracycline
previously treated with standard anthracycline
Must have received: alkylating agent (cyclophosphamide)
previously treated with cyclophosphamide
Must have received: taxane
previously treated with taxane chemotherapy
Cannot have received: systemic anti-cancer therapy
Exception: bortezomib while on study
Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to study treatment (this would not include bortezomib while on study)
Cannot have received: monoclonal antibody
Monoclonal antibody agents should have a 4-week (28 day) washout period
Lab requirements
Blood counts
ANC >1500/μL; Platelet count ≥100,000/μL; Hemoglobin ≥9 g/dL or ≥5.6 mmol/L
Kidney function
Serum creatinine ≤1.5 x ULN or calculated creatinine clearance of ≥30 mL/min
Liver function
AST and ALT ≤2.5 x ULN or ≤5 x ULN in presence of liver metastases; Total bilirubin ≤1.5 x ULN OR direct bilirubin ≤ULN for patients with total bilirubin levels >1.5 × ULN
adequate hematologic function...adequate liver function...adequate renal function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Baylor University Medical Center, Baylor Charles A Sammons Cancer Center · Dallas, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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