Study on Dato-DXd With or Without Durvalumab Compared to Other Treatments for Stage I-III Triple-negative Breast Cancer After Initial Therapy (TROPION-Breast03)

Inclusion Criteria

• Must be 18 years or older.
• Have confirmed invasive triple-negative breast cancer (TNBC).
• Have cancer remaining in the breast or lymph nodes after surgery and initial therapy.
• Completed at least 6 cycles of initial therapy with specific chemotherapy drugs.
• No signs of cancer spreading to other parts of the body.
• All visible cancer in the breast and lymph nodes must have been surgically removed.
• Be in good general health with a performance status of 0 or 1.
• Provide a tumor sample from surgery for analysis.
• No additional systemic therapy after surgery.
• If needed, radiation therapy must be completed before starting the study treatment.
• If radiation therapy was given after surgery, it must be completed within 6 weeks before starting the study treatment.
• Have a heart function test showing at least 50% function.
• Eligible for one of the standard therapy options as assessed by the doctor.
• No known harmful mutations in BRCA1 or BRCA2 genes.
• Have adequate blood cell counts and organ function.

Exclusion Criteria

• Have stage IV (metastatic) triple-negative breast cancer.
• Have had another invasive breast cancer or signs of cancer returning after initial therapy and surgery.
• Have severe or uncontrolled medical conditions, including certain infections or diseases.
• Have had another cancer within the last 5 years, except for certain skin cancers or other low-risk cancers.
• Have ongoing side effects from previous cancer treatments, except for hair loss.
• Have active autoimmune or inflammatory disorders.
• Have significant eye disease.
• Have active hepatitis B or C, or uncontrolled HIV infection.
• Have active tuberculosis.
• Have heart rhythm issues or significant heart disease.
• Have lung disease or breathing problems.
• Have active liver disease.
• Have severe nerve damage.
• Have used certain immune system drugs recently.
• Have severe allergies to study drugs or similar medications.
• Are pregnant, breastfeeding, or planning to become pregnant during the study.