Phase II Study of Trilaciclib, Pembrolizumab, Gemcitabine, and Carboplatin for Advanced Triple-Negative Breast Cancer

Inclusion Criteria

• Must provide written consent to participate.
• Men or women with advanced triple-negative breast cancer that cannot be removed by surgery or has spread.
• Must be 18 years or older.
• Must be in good overall health, with a performance status score of 0 or 1.
• Cancer must be confirmed as estrogen and progesterone receptor-negative and HER2-negative.
• Must have measurable cancer according to specific criteria.
• Must have adequate organ function.
• Women of childbearing potential must have a negative pregnancy test before starting treatment and agree to use contraception.
• Must be willing to provide tumor tissue for research.
• Must have a life expectancy of at least 12 weeks.

Exclusion Criteria

• Have had more than 3 previous chemotherapy treatments for advanced triple-negative breast cancer.
• Have previously received gemcitabine and carboplatin together for metastatic cancer.
• Have active or untreated cancer in the brain or spinal cord.
• Have had recent cancer treatments or surgery that have not fully healed.
• Have an active infection requiring treatment.
• Are pregnant or breastfeeding.
• Have another cancer diagnosis within the last five years, except for certain skin or cervical cancers.
• Have taken an investigational drug recently.
• Have uncontrolled health conditions, such as heart failure or psychiatric illness.
• Have a history of stroke or cerebrovascular event within the last 6 months.
• Have allergies to any of the study drugs.
• Have a history of lung disease requiring steroids.
• Have an active autoimmune disease requiring treatment in the last 2 years.
• Have had a stem cell or organ transplant.
• Have HIV, active hepatitis B, or active hepatitis C.
• Have received a live vaccine recently or plan to during the study.