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HER2 Negative Breast Carcinoma / Anatomic Stage III Breast Cancer AJCC V8 / Anatomic Stage Ii Breast Cancer AJCC V8 · Phase 3 Trial
ClinicalTrials.gov · August 10, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 3 randomized trial currently recruiting to evaluate whether adding the PD-L1 inhibitor durvalumab to standard chemotherapy (paclitaxel, cyclophosphamide, doxorubicin) improves breast cancer event-free survival in patients with stage II–III hormone receptor-positive, HER2-negative breast cancer selected by MammaPrint High 2 Risk genomic profiling. No results have been reported in this registry record.
Phase 3, Interventional, Randomized, Sequential, Open label, Treatment purpose. Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, HER2-Negative Breast Carcinoma, Hormone Receptor-Positive Breast Carcinoma; age from 18 Years. Intervention: Step 1 (MammaPrint testing); Step 2, Arm 2 (chemotherapy, durvalumab). Compared with: Step 2, Arm 1 (chemotherapy) — Active Comparator. n = 3,680. 545 sites: United States, Puerto Rico.
This is a Phase 3 randomized trial currently recruiting to evaluate whether adding the PD-L1 inhibitor durvalumab to standard chemotherapy (paclitaxel, cyclophosphamide, doxorubicin) improves breast cancer event-free survival in patients with stage II–III hormone receptor-positive, HER2-negative breast cancer selected by MammaPrint High 2 Risk genomic profiling. No results have been reported in this registry record.
No efficacy or safety results have been reported in this registry record; the study is actively recruiting.
This trial is not yet informative. When results become available, they will determine whether durvalumab added to standard neoadjuvant or adjuvant chemotherapy improves event-free survival in this molecularly-defined, high-risk breast cancer subgroup.
This is a Phase 3 trial registration with no results posted; the study is still recruiting and has not yet reported outcomes.
As stated by the source record.
Quoted from the source exactly as published.
This trial is not yet informative. When results become available, they will determine whether durvalumab added to standard neoadjuvant or adjuvant chemotherapy improves event-free survival in this molecularly-defined, high-risk breast cancer subgroup.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT06058377). This is a study registration, not published results. Lead sponsor: National Cancer Institute (NCI). Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 3680 participants (ESTIMATED). Conditions: Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, HER2-Negative Breast Carcinoma, Hormone Receptor-Positive Breast Carcinoma. Interventions: PROCEDURE: Biospecimen Collection; DRUG: Cyclophosphamide; DRUG: Doxorubicin; BIOLOGICAL: Durvalumab; OTHER: Genetic Testing; PROCEDURE: Mammography; DRUG: Paclitaxel; OTHER: Quality-of-Life Assessment. Primary outcome measures: Breast cancer event-free survival (BC-EFS) , Up to 10 years after completion of study treatment. Brief summary: 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.