Overview

Evaluate the efficacy and safety of Disitamb Vedotin combined with pyrotinib in HER2 positive early breast cancer

Eligibility

Inclusion Criteria:

        1.18 to 75 years old (at the time of signing the informed consent form), regardless of
        gender.
        2. Subject type and disease characteristics. Histologically confirmed HER2 positive EBC
        subjects:
          1. evaluated as HER2 positive in local laboratories according to ASCOCAP guidelines.
          2. Single and multifocal tumors (greater than 1 tumor area limited to the same quadrant
             as the primary tumor) must be sampled from 1 lesion and laboratory confirmed as HER2
             positive.
          3. Multicenter tumors (multiple tumors involving more than one breast quadrant) must
             sample one lesion from each affected quadrant and be confirmed as HER2 positive by the
             central laboratory.
          4. According to ASCOCAP guidelines, tumors are either HR positive or HR negative (ER and
             PgR negative).
          5. Clinical staging at visit (based on breast X-ray or breast MRI evaluation): Stage
             II-IIIC determined by the AJCC staging system, 8th edition. (f) Lymph node involvement
             is determined by fine needle aspiration or coarse needle aspiration biopsy (if
             applicable).
             3. When randomized, ECOG physical fitness status is 0 or 1 point.
             Exclusion Criteria:
               1. Previous history of invasive breast cancer.
               2. Stage IV breast cancer according to AJCC staging system version 8.
               3. Within 3 years, there is any primary malignant tumor, except for fully resected
                  non-melanoma skin cancer or cured in situ disease.
               4. DCIS medical history, except for the subjects who only received Mastectomy
               5. According to the judgment of the researchers, there is evidence of any diseases
                  (such as severe or uncontrolled systemic diseases, including persistent or active
                  infections, uncontrolled hypertension, kidney transplantation and active bleeding
                  diseases, and severe chronic gastrointestinal diseases related to diarrhea) that
                  the researchers consider to be unfavorable for the participants to participate in
                  the study or may affect adherence to the protocol.
               6. Uncontrolled infection requiring intravenous administration of antibiotics,
                  Antiviral drug or antifungal drugs.