OncoMatch/Clinical Trials/NCT07078604
A Cancer Vaccine (STEMVAC) in Combination With Chemotherapy for the Treatment of PD-L1 Negative Metastatic Triple-Negative Breast Cancer
Is NCT07078604 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for anatomic stage iv breast cancer ajcc v8.
Treatment: CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine · Cisplatin · Docetaxel · Doxorubicin · Eribulin · Paclitaxel · Pegylated Liposomal Doxorubicin Hydrochloride · Sargramostim · Carboplatin — This phase II trial studies how well a cancer vaccine called STEMVAC works in combination with chemotherapy in treating patients with PD-L1 negative, triple-negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic). STEMVAC is designed to target proteins that are expressed on breast cancer stem cells, and it is believed to work by boosting the immune system to recognize and destroy the invader tumor cells that are causing the disease. The allowable combination chemotherapy includes: (1) Paclitaxel is in a class of chemotherapy medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. (2) Docetaxel is in a class of chemotherapy medications called taxanes. It stops tumor cells from growing and dividing and may kill them. (3) Cisplatin is in a class of chemotherapy medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. (4) Carboplatin is in a class of chemotherapy medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. (5) Doxorubicin is in a class of chemotherapy medications called anthracyclines. Doxorubicin damages the cell's deoxyribonucleic acid (DNA) and may kill tumor cells. It also blocks a certain enzyme needed for cell division and DNA repair. (6) Liposomal doxorubicin is a form of the anticancer drug doxorubicin that is contained inside very tiny, fat-like particles. Liposomal doxorubicin may have fewer side effects and work better than other forms of the drug. (7) Eribulin is in a class of chemotherapy medications called microtubule dynamics inhibitors. It works by stopping the growth and spread of tumor cells. Giving STEMVAC in combination with chemotherapy may be an effective treatment for PD-L1 negative metastatic triple-negative breast cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Triple-Negative Breast Cancer
Biomarker criteria
Required: PD-L1 (CD274) negative for PD-L1 marker testing per standard of care antibodies/clones in breast cancer at time of eligibility (negative)
Tumor is negative for PD-L1 marker testing per standard of care antibodies/clones in breast cancer at time of eligibility
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: cancer immunotherapy
Exception: in metastatic setting
Patients should not have received any prior cancer immunotherapy in the metastatic setting
Lab requirements
Blood counts
WBC ≥ 2500/mm^3; lymphocyte count ≥ 500/mm^3; ANC ≥ 1000/μL; Hgb ≥ 9 g/dl; platelets ≥ 75,000/μL
Kidney function
Creatinine ≤ 1.5 X ULN mg/dL or creatinine clearance > 60 ml/min
Liver function
Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN), except patients with Gilbert's syndrome in whom total bilirubin must be < 3.0 mg/dL; AST/ALT ≤ 1.5 X institutional ULN
WBC ≥ 2500/mm^3; lymphocyte count ≥ 500/mm^3; ANC ≥ 1000/μL; Hgb ≥ 9 g/dl; platelets ≥ 75,000/μL; Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN), except patients with Gilbert's syndrome in whom total bilirubin must be < 3.0 mg/dL; AST/ALT ≤ 1.5 X institutional ULN; Creatinine ≤ 1.5 X ULN mg/dL or creatinine clearance > 60 ml/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Fred Hutch/University of Washington Cancer Consortium · Seattle, Washington
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