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Study identifier: NCT06058377 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Adding an Immunotherapy Drug, MEDI4736 (Durvalumab), to the Usual Chemotherapy Treatment (Paclitaxel, Cyclophosphamide, and Doxorubicin) for Stage II-III Breast Cancer

Condition: Anatomic Stage II Breast Cancer AJCC v8 · Anatomic Stage III Breast Cancer AJCC v8 · HER2-Negative Breast Carcinoma  ·  Sponsor: National Cancer Institute (NCI)

PhasePhase 3
Planned participants3680
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

This phase III trial compares the addition of an immunotherapy drug (durvalumab) to usual chemotherapy versus usual chemotherapy alone in treating patients with MammaPrint High 2 Risk (MP2) stage II-III hormone receptor positive, HER2 negative breast cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as paclitaxel, doxorubicin, and cyclophosphamide 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. There is some evidence from previous clinical trials that people who have a MammaPrint High 2 Risk result may be more likely to respond to chemotherapy and immunotherapy. Adding durvalumab to usual chemotherapy may be able to prevent the cancer from returning for patients with MP2 stage II-III hormone receptor positive, HER2 negative breast cancer.

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

Talk to the study team

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

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Locations (543)

University of Alabama at Birmingham Cancer CenterBirmingham, Alabama, United StatesRecruiting
Katmai Oncology GroupAnchorage, Alaska, United StatesRecruiting
University of Arizona Cancer Center-Orange Grove CampusTucson, Arizona, United StatesRecruiting
Banner University Medical Center - TucsonTucson, Arizona, United StatesRecruiting
University of Arizona Cancer Center-North CampusTucson, Arizona, United StatesRecruiting
Mercy Hospital Fort SmithFort Smith, Arkansas, United StatesRecruiting
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - JonesboroJonesboro, Arkansas, United StatesRecruiting
University of Arkansas for Medical SciencesLittle Rock, Arkansas, United StatesRecruiting
Sutter Auburn Faith HospitalAuburn, California, United StatesRecruiting
AIS Cancer Center at San Joaquin Community HospitalBakersfield, California, United StatesRecruiting
Alta Bates Summit Medical Center-Herrick CampusBerkeley, California, United StatesRecruiting
Tower Cancer Research FoundationBeverly Hills, California, United StatesRecruiting

+ 531 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06058377