Study Comparing Dato-DXd with Chemotherapy for Patients with Advanced Triple-negative Breast Cancer Not Suitable for PD-1/PD-L1 Inhibitors

Inclusion Criteria

• Must be 18 years or older.
• Have advanced triple-negative breast cancer that cannot be surgically removed or has spread to other parts of the body.
• Cancer must be negative for estrogen, progesterone, and HER2 receptors.
• No previous chemotherapy for advanced breast cancer.
• Not eligible for PD-1/PD-L1 inhibitor therapy.
• Have at least one measurable tumor that can be tracked with scans.
• Be in good overall health with a performance status of 0 or 1.
• Eligible for one of the chemotherapy options listed in the study.
• Have had enough time since any previous treatments to ensure safety.
• Provide a tumor sample for analysis.
• Have stable brain metastases, if present, and not require treatment with steroids or anticonvulsants.
• Have adequate organ and bone marrow function.
• Have a life expectancy of at least 12 weeks.
• Agree to use effective contraception if of childbearing potential.
• Able to give informed consent and comply with study requirements.

Exclusion Criteria

• Have severe or uncontrolled medical conditions that could interfere with the study.
• Have another active cancer within the past 3 years, except for certain skin cancers or in situ cancers.
• Have unresolved side effects from previous cancer treatments.
• Have active infections or uncontrolled hepatitis B or C.
• Have uncontrolled HIV infection.
• Have significant heart disease or abnormal heart rhythms.
• Have high calcium levels in the blood.
• Have lung diseases like pneumonitis.
• Have leptomeningeal disease (cancer spread to the membranes around the brain and spinal cord).
• Have significant eye disease.
• Have active tuberculosis.
• Have had certain previous cancer treatments that are not allowed in the study.
• Be currently receiving other cancer treatments.
• Be pregnant or breastfeeding, or planning to become pregnant during the study.
• Have a history of severe allergic reactions to study drugs or similar medications.
• Be involved in planning or conducting the study.