Phase II Study of Pembrolizumab and Nab-paclitaxel for HER-2 Negative Metastatic Breast Cancer

Inclusion Criteria

• Have a confirmed diagnosis of breast cancer that is either triple negative or hormone receptor-positive and HER-2 negative.
• Have received up to two previous chemotherapy treatments for metastatic breast cancer.
• Be willing to provide written consent to participate in the study.
• Be 18 years or older.
• Have measurable cancer that can be tracked during the study.
• Be willing to provide a recent tumor sample for analysis.
• Have a good performance status, meaning you are fully active or have some restrictions but can still do light work.
• Have mild or no existing nerve damage.
• Have adequate organ function based on recent lab tests.
• Women of childbearing potential must have a negative pregnancy test before starting treatment and agree to use effective birth control during the study.
• Men must agree to use a condom during sexual activity and avoid fathering a child during the study and for six months after.

Exclusion Criteria

• Currently participating in another study or have recently received an investigational treatment.
• Have an immune system deficiency or are taking medications that suppress the immune system.
• Have a history of active tuberculosis.
• Are allergic to pembrolizumab or its ingredients.
• Have received certain cancer treatments recently and have not recovered from their side effects.
• Have another active cancer that required treatment in the last five years, except for certain skin cancers or cervical cancer.
• 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 two years.
• Have a history of lung inflammation or disease.
• Have an active infection requiring treatment.
• Have any condition that might interfere with the study or your ability to participate.
• Are pregnant or breastfeeding, or planning to conceive or father a child during the study.
• Have previously received certain immune therapies.
• Have a known history of HIV or active hepatitis B or C.
• Have received a live vaccine recently.