Study on Nivolumab and Chemotherapy Before Surgery for Localized Triple-negative Breast Cancer

Inclusion Criteria

• Diagnosed with a specific type of breast cancer called triple-negative breast cancer, confirmed by lab tests.
• Cancer must be at stage II or III and suitable for chemotherapy before surgery.
• Tumor size must be at least 2 cm in one dimension, or have confirmed lymph node involvement.
• No previous treatment for this cancer.
• Aged 18 or older.
• Generally healthy with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
• Normal blood and organ function based on specific lab tests.
• Women of childbearing potential must have a negative pregnancy test and agree to use contraception during and for five months after treatment.
• Must not be breastfeeding.
• Willing to provide tumor samples before and during treatment.
• Able to understand and sign a consent form and comply with study requirements.

Exclusion Criteria

• Previous treatment with immunotherapy for cancer.
• Cancer that has spread to other parts of the body.
• Cancer in the other breast.
• History of other cancers unless treated and disease-free for at least one year.
• Currently taking other experimental drugs.
• Allergic reactions to similar drugs used in the study.
• Active infections requiring treatment within seven days before starting the study.
• Previous bone marrow or organ transplants.
• Autoimmune diseases, unless well-controlled.
• Lung diseases like pneumonitis or fibrosis.
• Uncontrolled heart disease.
• Chronic hepatitis B or C, or active tuberculosis.
• Major surgery within 28 days before starting the study, except for planned breast cancer surgery.
• Any medical condition that could interfere with the study.
• Use of certain immunosuppressive medications within two weeks before starting the study.
• Blood clotting disorders or bleeding issues.
• Ascites requiring medical management.
• HIV-positive patients must be on stable treatment, with no need for additional infection prevention medications, and have a CD4 count above 250 and undetectable viral load.