University of Washington
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. Chemotherapy drugs 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. Giving STEMVAC in combination with chemotherapy may be an effective treatment for PD-L1 negative metastatic triple-negative breast cancer.
OUTLINE: Patients receive systemic standard of care chemotherapy as determined by their attending medical oncologist. Patients receive 3 priming doses of STEMVAC with sargramostim intradermally (ID) every 21-28 days (7-13 days after each chemotherapy administration or during the off week of weekly chemotherapy), 2 booster STEMVAC/sargramostim doses at 4 and 7 months after 3rd priming dose, and then every 6 months in the absence of disease progression or unacceptable toxicity. Patients also undergo image-guided biopsy, for research purposes, on study, as well as computed tomography (CT) or pos…
Inclusion Criteria: * Patients must be at least ≥ 18 years of age * Note: Because no dosing or adverse event (AE) data are currently available on the use of STEMVAC in patients \< 18 years of age, children and adolescents are excluded from this study, but will be eligible for future pediatric trials, if applicable * Patients with Eastern Cooperative Oncology Group (ECOG) Performance Status Score of ≤ 2 * Histologically confirmed triple-negative breast cancer * Tumors with estrogen receptor (ER)-low (≤ 5%) or negative and progesterone receptor (PR)-low (≤ 5%) or negative will be included…
Given ID
Given standard of care chemotherapy
Undergo CT scans
Given ID
Undergo blood sample collection
Undergo PET scan
Undergo image-guided biopsy
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