A Study of Trastuzumab Rezetecan in Combination With Adebrelimab Versus Investigator's Choice of Therapy in Subjects With Residual Triple Negative Breast Cancer

Korábbi kezelés

• Previously received antibody coupled drug (ADC) therapy with topoisomerase inhibitors as effective payloads.
• Previously received HER2 targeted therapy.
• Active or previously recorded autoimmune or inflammatory diseases.
• Within the 6 months prior to randomization, there was a history of myocardial infarction, severe/unstable angina, symptomatic congestive heart failure, ≥ Grade 2 supraventricular or ventricular arrhythmias, and any grade of ventricular fibrillation.
• Known allergy to any investigational drug or its excipients.

Más betegség

• Stage IV metastatic breast cancer.
• Previous invasive breast cancer or ductal carcinoma in situ.
• Bilateral breast cancer.
• Any clinical evidence indicating the exist of recurrent diseases after surgery.
• History of other malignancy within the last 5 years, excluding cured skin basal cell carcinoma and cervical carcinoma in situ.
• History of immunodeficiency.
• Presence of active Hepatitis B.
• Known to have active tuberculosis infection.
• Uncontrolled infections requiring intravenous injection of antibiotics, antiviral drugs, or antifungal drugs for treatment.
• Other medical conditions that would interfere with study participation or follow-up.

Egyéb

• Participants with known or suspected interstitial pneumonia.

• Pathologically confirmed invasive triple negative breast cancer.
• Pathologic evidence of residual invasive carcinoma in the breast or axillary lymph nodes following completion of preoperative therapy.
• Previous neoadjuvant therapy must meet the requirements of the protocol.
• Has received radical surgery for breast cancer.
• ECOG PS 0~1.
• Adequate organ functions.
• Women of childbearing potential must be willing to use highly effective form of contraception.