Study on Standard Chemotherapy Plus Pembrolizumab for Breast Cancer

Inclusion Criteria

• Be willing and able to provide written consent to participate.
• Be at least 18 years old.
• Have HER2-negative breast cancer.
• Have ER and PR-negative breast cancer.
• Have advanced cancer that cannot be surgically removed or has spread, as confirmed by scans.
• Be eligible for treatment with either weekly paclitaxel or oral capecitabine as determined by the doctor.
• Be willing to provide a new or recent tumor sample for analysis.
• Have a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
• Have adequate organ function based on lab tests.
• Women of childbearing potential must have a negative pregnancy test before starting treatment and must avoid becoming pregnant during treatment. Men must avoid fathering a child during treatment.

Exclusion Criteria

• Currently participating in another study or have recently participated in a study with an investigational drug or device.
• Have an immune system deficiency or are taking medications that suppress the immune system.
• Have a history of active tuberculosis.
• Have an allergy to pembrolizumab or its ingredients.
• Have received certain cancer treatments recently and have not recovered from side effects.
• Have received the same chemotherapy regimen before in the metastatic setting or within 12 months in the adjuvant setting.
• Have had major surgery recently and have not fully recovered.
• Have another cancer that has progressed or required treatment in the last 5 years.
• Have active cancer spread to the brain or spinal cord unless stable and not requiring steroids.
• Have an active autoimmune disease requiring treatment in the past 2 years.
• Have a history of lung inflammation requiring steroids.
• Have an active infection requiring treatment.
• Have any condition that might interfere with the study or is not in the best interest of the patient to participate.
• Have psychiatric or substance abuse disorders that would interfere with the study.
• Are pregnant or breastfeeding, or planning to conceive or father a child during the study and for 120 days after the last treatment.
• Have received prior therapy with certain immune checkpoint inhibitors.
• Have a history of HIV.
• Have active Hepatitis B or C.
• Have received a live vaccine recently.