Study on Sacituzumab Tirumotecan Alone and with Pembrolizumab for Treating Triple-Negative Breast Cancer

Inclusion Criteria

• Have triple-negative breast cancer that has come back or spread and cannot be treated with surgery.
• Have not received treatment for the cancer that has come back or spread.
• If previously treated for early-stage breast cancer, must have finished all treatments at least 6 months before the cancer returned.
• Be eligible for treatment with one of the following options: paclitaxel, nab-paclitaxel, or gemcitabine with carboplatin.
• Any side effects from previous cancer treatments must have improved to mild levels, except for hair loss or skin changes like vitiligo.
• If you have hepatitis B, you must have been on antiviral treatment for at least 4 weeks and have no detectable virus.
• If you have had hepatitis C, the virus must be undetectable.

Exclusion Criteria

• Have breast cancer that can be treated with surgery.
• Have TNBC with a high level of a specific protein (PD-L1) in the tumor.
• Have already received treatment for the cancer that has come back or spread.
• Have moderate to severe nerve damage.
• Have severe eye conditions that affect healing.
• Have active inflammatory bowel disease needing medication or a history of it.
• Have uncontrolled heart or blood vessel disease.
• Have cancer that has only spread to the skin.
• Have cancer that has spread to organs and is causing severe symptoms.
• Have HIV with a history of certain related diseases.
• Have another cancer that is growing or needed treatment in the last 5 years.
• Have active cancer spread to the brain or spinal fluid, unless previously treated and stable.
• Have an autoimmune disease needing treatment in the last 2 years, except for hormone replacement.
• Have a history of lung inflammation needing steroids or current lung disease.
• Have active hepatitis B or C infections.
• Have had a stem cell or organ transplant.
• Have not fully recovered from major surgery or have ongoing surgical issues.