Study Name: S2206

Recruiting

Breast

S2206, PHASE III TRIAL OF NEOADUVANT DURVALUMAB PLUS CHEMOTHERAPY VERSUS CHEMOTHERAPY ALONE FOR ADULTS WITH MAMMAPRINT UNLTRAHIGH HORMONE RECEPTOR POSITIVE, HER2 NEGATIVE STAGE II-III BREAST CANCER

NCT#06058377

clinicaltrials.gov/show/NCT06058377

This phase III trial compares the addition of an immunotherapy drug (durvalumab) to usual chemotherapy versus usual chemotherapy alone in treating patients with MammaPrint Ultrahigh (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 Ultrahigh 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.

Male and Female – 18 years and older

• ER positive and/or PR positive and HER2 negative breast cancer
• Clinical Stage II-III
• Must not have metastatic disease
• Must not have locally recurrent breast cancer
• Patients with multifocal disease or synchronous primary tumors are eligible, however all tumors must be ER positive and/or PR positive and HER2 negative
• Mammoprint Index Score of -1.0 to -0.57
• Must not have received any prior treatment for their current breast cancer