Study on Sacituzumab Tirumotecan Plus Pembrolizumab Versus Doctor's Choice Treatment in Triple-Negative Breast Cancer Patients Who Did Not Achieve Complete Response After Initial Therapy

Inclusion Criteria

• Diagnosed with triple-negative breast cancer (TNBC) as per the latest guidelines.
• No signs of cancer returning or spreading, as assessed by the doctor.
• Received initial treatment with pembrolizumab and chemotherapy, followed by surgery.
• All visible cancer in the breast and/or lymph nodes was surgically removed, and recovery from surgery is complete.
• Did not achieve a complete response to initial therapy at surgery.
• Able to continue receiving pembrolizumab after surgery.
• Randomization into the study must occur within 12 weeks after surgery.
• Completed any necessary radiation therapy and recovered before joining the study.
• Provided a tissue sample from surgery to check for a specific protein (TROP2).
• If capable of producing sperm, agrees to use effective birth control during the study and for a specified time after the last dose of study drugs.
• Women must not be pregnant or breastfeeding and must use effective birth control during the study and for a specified time after the last dose of study drugs.
• Any side effects from previous cancer treatments must have improved to a mild level or returned to baseline.
• HIV-positive participants must have well-controlled HIV on treatment.
• Good overall health with a performance status score of 0 or 1.
• Hepatitis B positive participants must have been on antiviral therapy and have an undetectable viral load before joining the study.

Exclusion Criteria

• Has a known BRCA gene mutation and is eligible for treatment with olaparib.
• Has severe nerve damage (Grade >2).
• Has severe eye conditions that affect healing.
• Has active inflammatory bowel disease requiring medication.
• Has uncontrolled heart or blood vessel disease.
• Previously treated with certain targeted cancer drugs.
• Received other cancer treatments after surgery, except for radiation.
• Taking certain medications that affect liver enzymes and cannot stop them for the study.
• Previously treated with certain immune therapies, except for pembrolizumab as initial therapy.
• Received other cancer treatments within 4 weeks before joining the study.
• Received radiation therapy within 3 weeks before starting the study.
• Received a live vaccine within 30 days before starting the study.
• Participated in another clinical trial within 4 weeks before joining the study.
• Has another active cancer requiring treatment within the past 5 years.
• Has an immune deficiency or is on high-dose steroids or other immune-suppressing drugs.
• Has an active autoimmune disease requiring treatment in the past 2 years.
• Has a history of lung inflammation requiring steroids.
• Has an active infection requiring treatment.
• HIV-positive participants with a history of certain cancers.
• Has active hepatitis B and C infections.
• Has had a tissue or organ transplant.