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NCT06058377 · ClinicalTrials.gov record · last posted 2026-08-27

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

StatusRecruiting
PhasePhase 3
Started2023-11-27
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from the ClinicalTrials.gov record
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.

Protocol amendment history 6 changes detected by DataLookout

2026-08-19
minor
Trial sites expanded: 545 → 552 locations
2026-06-04
critical
Primary completion pushed: 2027-05-31 → 2032-05-31
2026-06-04
minor
Completion pushed: 2027-05-31 → 2032-05-31
2026-05-16
critical
Primary completion pushed: 2026-05-31 → 2027-05-31
2026-05-16
minor
Completion pushed: 2026-05-31 → 2027-05-31
2026-05-08
minor
Trial sites expanded: 533 → 536 locations
Trial Details
NCT Number NCT06058377
Lead Sponsor National Cancer Institute (NCI)
Conditions Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, HER2-Negative Breast Carcinoma, Hormone Receptor-Positive Breast Carcinoma
Enrollment 3,680 participants
Start Date 2023-11-27
Primary Completion 2032-05-31 (estimated)
Study Completion 2032-05-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-27