OncoMatch/Clinical Trials/NCT04265872
Bortezomib Followed by Pembrolizumab and Cisplatin in metTNBC
Is NCT04265872 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Immunotherapy
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)
Demographics
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 →Frequently asked questions
Is NCT04265872 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic anti-cancer therapy, monoclonal antibody disqualifies patients from enrollment.
Does this trial require ESR1?
Yes, ESR1 negative is a required biomarker for enrollment.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages