T-DM1 Combined With CDK4/6 Inhibitor Ribociclib

Inclusion Criteria

• •Age ≥18 at the time of signing the informed consent.
• •Patient's ability to follow the study protocol as determined by the investigator.
• •A representative tumor tissue sample is required to confirm a HER2-positive diagnosis.
• •HER2 expression status and ER expression status of invasive cancer lesions were determined based on previous pathological sections or current pre-treatment biopsy materials, and the HER2 IHC assay was locally confirmed to be consistent with 3+, or IHC assay with 2+, and further FISH detection was positive before study enrollment.
• •At least one evaluable lesion was detected by CT or MRI (see protocol for additional details).
• •For metastatic or recurrent breast cancer, there is currently no opportunity for surgical radical resection.
• •Metastatic or recurrent breast cancer that has received at least first-line rescue therapy in the past must have been treated with trastuzumab and taxanes.
• •The Physical status (ECOG) score of the Eastern Tumor Collaboration group was 0 or 1.
• •Sufficient haematology and organ function to meet the definition of laboratory test results, which must be provided within 14 days before the start of study therapy.
• •Fertile women should remain abstinent (no heterosexual intercourse) or use contraceptive methods.