NCI-2023-04566

Phase III Trial of Neoadjuvant Durvalumab (NSC 778709) plus Chemotherapy versus Chemotherapy Alone for Adults with MammaPrint Ultrahigh (MP2) Hormone Receptor (HR) Positive / Human Epidermal Growth Factor Receptor (HER2) Negative Stage II-III Breast Cancer

This research study is testing whether adding an immunotherapy drug called durvalumab to standard chemotherapy before surgery helps women with stage II–III, hormone receptor-positive (HR+), HER2-negative breast cancer that’s been identified as ultrahigh risk by a genetic test called MammaPrint (MP2). MammaPrint MP2 is a test that looks at your tumor's genes and labels some cancers as ultrahigh risk—those more likely to come back. Previous research shows MP2 tumors have more immune activity, and patients may respond better when chemo is combined with immunotherapy. Durvalumab is already used in other cancers to help your immune system fight tumors.

immunotherapy: The immune system helps fight cancer by sending the body's defense (immune) system to kill the cancer cells. Immunotherapy drugs target cancer cells to prevent them from multiplying and growing.

hormone receptor-positive (HR+): It is a type of breast cancer where the cancer cells rely on hormones, such as estrogen and progesterone, to grow, but they don't have an overactive HER2 receptor.

HER2-negative breast cancer: It is a type of breast cancer where cancer cells have normal levels of the protein called HER-2. Cancer cells that are HER-2 negative grow more slowly and are less likely come back or spread to other parts of the body than cancers that have too much HER-2.

For more information about the trial, click the link below:

https://clinicaltrials.gov/ct2/show/NCT06058377

Clinical Trial Site: Sinai

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