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Study identifier: NCT03606967 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Testing the Addition of an Individualized Vaccine to Durvalumab and Tremelimumab and Chemotherapy in Patients With Metastatic Triple Negative Breast Cancer

Condition: Anatomic Stage IV Breast Cancer AJCC v8 · Invasive Breast Carcinoma · Metastatic Triple-Negative Breast Carcinoma  ·  Sponsor: National Cancer Institute (NCI)

PhasePhase 2
Planned participants86
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

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Contact details are listed per location below or on the registry record.

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Locations (30)

UC Irvine Health/Chao Family Comprehensive Cancer CenterOrange, California, United StatesActive Not Recruiting
University of California Davis Comprehensive Cancer CenterSacramento, California, United StatesTerminated
UCHealth University of Colorado HospitalAurora, Colorado, United StatesRecruiting
Smilow Cancer Hospital Care Center at Saint FrancisHartford, Connecticut, United StatesActive Not Recruiting
Yale UniversityNew Haven, Connecticut, United StatesActive Not Recruiting
UM Sylvester Comprehensive Cancer Center at AventuraAventura, Florida, United StatesRecruiting
UM Sylvester Comprehensive Cancer Center at Coral GablesCoral Gables, Florida, United StatesRecruiting
UM Sylvester Comprehensive Cancer Center at Deerfield BeachDeerfield Beach, Florida, United StatesRecruiting
University of Miami Miller School of Medicine-Sylvester Cancer CenterMiami, Florida, United StatesRecruiting
UM Sylvester Comprehensive Cancer Center at KendallMiami, Florida, United StatesRecruiting
UM Sylvester Comprehensive Cancer Center at PlantationPlantation, Florida, United StatesRecruiting
Moffitt Cancer Center-International PlazaTampa, Florida, United StatesRecruiting

+ 18 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT03606967