OncoMatch/Clinical Trials/NCT03606967
Testing the Addition of an Individualized Vaccine to Durvalumab and Tremelimumab and Chemotherapy in Patients With Metastatic Triple Negative Breast Cancer
Is NCT03606967 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies multiple treatments for anatomic stage iv breast cancer ajcc v8.
Treatment: Carboplatin · Durvalumab · Gemcitabine Hydrochloride · Nab-paclitaxel · Personalized Synthetic Long Peptide Vaccine · Poly ICLC · Sacituzumab Govitecan · Tremelimumab — This phase II trial studies how well nab-paclitaxel, durvalumab, and tremelimumab with or without personalized synthetic long peptide vaccine (neoantigen vaccine) works in treating patients with triple negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Chemotherapy drugs, such as nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as durvalumab and tremelimumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. It is not yet known whether giving nab-paclitaxel, durvalumab, and tremelimumab with or without neoantigen vaccine will work better in treating patients with triple negative breast cancer.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Targeted therapy
Chemotherapy
Other
Cancer type
Breast Carcinoma
Triple-Negative Breast Cancer
Biomarker criteria
Required: PD-L1 (CD274) wild-type (negative)
Required: HER2 (ERBB2) wild-type (ihc 0 or 1+ or fish negative)
Required: ESR1 expression (allred score < 3 or < 1% positive staining cells)
Required: PR (PGR) expression (allred score < 3 or < 1% positive staining cells)
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic therapy for metastatic tnbc
Cannot have received: taxane-based adjuvant therapy
Exception: disease-free interval of at least 12 months after completion of taxane therapy
Cannot have received: immunotherapy for metastatic disease
Lab requirements
Blood counts
absolute neutrophil count ≥ 1,500/mcl; platelets ≥ 100,000/mcl; hemoglobin ≥ 9.0 g/dl
Kidney function
calculated creatinine clearance > 40 ml/min by cockcroft-gault or 24-hour urine collection
Liver function
serum bilirubin ≤ 1.5 x institutional upper limit of normal; ast/alt ≤ 2.5 x uln unless liver metastases are present, in which case ≤ 5 x uln
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- UC Irvine Health/Chao Family Comprehensive Cancer Center · Orange, California
- University of California Davis Comprehensive Cancer Center · Sacramento, California
- UCHealth University of Colorado Hospital · Aurora, Colorado
- Smilow Cancer Hospital Care Center at Saint Francis · Hartford, Connecticut
- Yale University · New Haven, Connecticut
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT03606967 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic therapy for metastatic tnbc, taxane-based adjuvant therapy, immunotherapy for metastatic disease disqualifies patients from enrollment.
Does this trial require CD274?
Yes, CD274 wild-type is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 wild-type is a required biomarker for enrollment.
Does this trial require ESR1?
Yes, ESR1 expression is a required biomarker for enrollment.
What disease stage is eligible?
Stage IV is required (metastatic disease required).
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 qualify