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Checking the Benefits of a Personalized Vaccine for Breast Cancer Treatment

NCT03606967 · Recruiting
About this trial

This trial looks at how well a new personalized vaccine works when added to standard treatments for metastatic triple negative breast cancer. The main goal is to see if combining nab-paclitaxel, durvalumab, and tremelimumab with this vaccine helps patients more than just the standard treatments alone. The trial will also explore any changes in the immune system and how safe these treatments are for patients.

Locations and contact

This trial is running at 30 locations in the United States. 24 of them are currently recruiting.

United States30 locations · 24 recruiting
  • Johns Hopkins University/Sidney Kimmel Cancer CenterBaltimore, MarylandRecruiting
  • Moffitt Cancer CenterTampa, FloridaRecruiting
  • Moffitt Cancer Center - McKinley CampusTampa, FloridaRecruiting
  • Moffitt Cancer Center at Wesley ChapelWesley Chapel, FloridaRecruiting
  • Moffitt Cancer Center-International PlazaTampa, FloridaRecruiting
  • NYP/Weill Cornell Medical CenterNew York, New YorkRecruiting
  • Ohio State University Comprehensive Cancer CenterColumbus, OhioRecruiting
  • Siteman Cancer Center at Christian HospitalSt Louis, MissouriRecruiting
  • Siteman Cancer Center at Saint Peters HospitalCity of Saint Peters, MissouriRecruiting
  • Siteman Cancer Center at West County HospitalCreve Coeur, MissouriRecruiting
  • Siteman Cancer Center-South CountySt Louis, MissouriRecruiting
  • UCHealth University of Colorado HospitalAurora, ColoradoRecruiting
  • UM Sylvester Comprehensive Cancer Center at AventuraAventura, FloridaRecruiting
  • UM Sylvester Comprehensive Cancer Center at Coral GablesCoral Gables, FloridaRecruiting
  • UM Sylvester Comprehensive Cancer Center at Deerfield BeachDeerfield Beach, FloridaRecruiting
  • UM Sylvester Comprehensive Cancer Center at KendallMiami, FloridaRecruiting
  • UM Sylvester Comprehensive Cancer Center at PlantationPlantation, FloridaRecruiting
  • University of Miami Miller School of Medicine-Sylvester Cancer CenterMiami, FloridaRecruiting
  • University of Pittsburgh Cancer Institute (UPCI)Pittsburgh, PennsylvaniaRecruiting
  • University of Texas Medical BranchGalveston, TexasRecruiting
  • VCU Massey Comprehensive Cancer CenterRichmond, VirginiaRecruiting
  • Wake Forest University at ClemmonsClemmons, North CarolinaRecruiting
  • Wake Forest University Health SciencesWinston-Salem, North CarolinaRecruiting
  • Washington University School of MedicineSt Louis, MissouriRecruiting
  • Dartmouth Hitchcock Medical Center/Dartmouth Cancer CenterLebanon, New HampshireSuspended
  • Smilow Cancer Hospital Care Center at Saint FrancisHartford, ConnecticutActive Not Recruiting
  • UC Irvine Health/Chao Family Comprehensive Cancer CenterOrange, CaliforniaActive Not Recruiting
  • University of California Davis Comprehensive Cancer CenterSacramento, CaliforniaTerminated
  • University of Oklahoma Health Sciences CenterOklahoma City, OklahomaActive Not Recruiting
  • Yale UniversityNew Haven, ConnecticutActive Not Recruiting
Who to ask about joining
Site Public Contact720-848-0650
Site Public Contact954-461-2180
Site Public Contact305-243-2647
Who can join

Adults aged 18 and older can join the study. This includes men and women with confirmed metastatic triple negative breast cancer. Patients should not have had previous treatments for this type of cancer, and they need to meet specific health criteria. The trial team will check to confirm who is eligible.

What happens during the trial

Participants will be placed into one of two groups by chance. One group will receive the new vaccine along with standard treatments. The other group will receive just the standard treatments without the vaccine. Everyone will also undergo some tests, including biopsies and scans, to track progress and response to the treatment.

The trial team

The trial is sponsored by the National Cancer Institute (NCI). The principal investigator is Dr. William E. Gillanders from Yale University Cancer Center.

Important dates

The trial started on April 13, 2021, and is expected to finish by December 30, 2026. It is currently recruiting new participants.

Additional information

The trial's ID number is NCT03606967. It is a Phase 2 trial, which means the team is studying how well the treatment works and its safety. The trial is FDA-regulated and hopes to include about 70 participants.

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