RecruitingPhase IIEN original

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

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Potwierdzony rozpoznaniem raka piersi potrójnie ujemnego z przerzutami
  • Brak receptorów estrogenowych i progesteronowych (wynik poniżej progu)
  • Brak białka HER2 potwierdzone badaniem laboratoryjnym
  • Brak białka PD-L1 potwierdzone badaniem laboratoryjnym
  • Wiek co najmniej 18 lat
  • Ogólny stan zdrowia pozwalający na aktywność (ECOG 0-1)
  • Wystarczająca liczba białych krwinek, płytek krwi i hemoglobiny
  • Prawidłowe parametry wątroby i nerek

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
June 12, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (30)

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, United States

University of California Davis Comprehensive Cancer Center

Sacramento, United States

UCHealth University of Colorado Hospital

Aurora, United States

Smilow Cancer Hospital Care Center at Saint Francis

Hartford, United States

Yale University

New Haven, United States

UM Sylvester Comprehensive Cancer Center at Aventura

Aventura, United States

UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, United States

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, United States

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, United States

UM Sylvester Comprehensive Cancer Center at Kendall

Miami, United States

UM Sylvester Comprehensive Cancer Center at Plantation

Plantation, United States

Moffitt Cancer Center-International Plaza

Tampa, United States

Moffitt Cancer Center - McKinley Campus

Tampa, United States

Moffitt Cancer Center

Tampa, United States

Moffitt Cancer Center at Wesley Chapel

Wesley Chapel, United States

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, United States

Siteman Cancer Center at Saint Peters Hospital

City of Saint Peters, United States

Siteman Cancer Center at West County Hospital

Creve Coeur, United States

Washington University School of Medicine

St Louis, United States

Siteman Cancer Center-South County

St Louis, United States

Siteman Cancer Center at Christian Hospital

St Louis, United States

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Lebanon, United States

NYP/Weill Cornell Medical Center

New York, United States

Wake Forest University at Clemmons

Clemmons, United States

Wake Forest University Health Sciences

Winston-Salem, United States

Ohio State University Comprehensive Cancer Center

Columbus, United States

University of Oklahoma Health Sciences Center

Oklahoma City, United States

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, United States

University of Texas Medical Branch

Galveston, United States

VCU Massey Comprehensive Cancer Center

Richmond, United States

Trial contact

Site Public Contact

Jennifer R. Diamond

PRINCIPAL_INVESTIGATOR

Site Public Contact

Alejandra T. Perez

PRINCIPAL_INVESTIGATOR

Site Public Contact

Aixa E. Soyano

PRINCIPAL_INVESTIGATOR

Site Public Contact

Cesar A. Santa-Maria

PRINCIPAL_INVESTIGATOR

William E. Gillanders

PRINCIPAL_INVESTIGATOR

Site Public Contact

Massimo Cristofanilli

PRINCIPAL_INVESTIGATOR

Site Public Contact

Emily H. Douglas

PRINCIPAL_INVESTIGATOR

Site Public Contact

Kai C. Johnson

PRINCIPAL_INVESTIGATOR

Site Public Contact

Julia Foldi

PRINCIPAL_INVESTIGATOR

Avi B. Markowitz

PRINCIPAL_INVESTIGATOR

Masey M. Ross

PRINCIPAL_INVESTIGATOR

Contact information from ClinicalTrials.gov. Contact in English.

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.