This is a randomized, open, positive drug control, multi center phase III study. Through the evaluation of tpCR, bpCR, ORR, EFS, IDFS, OS , AEs and other indicators, it proves the effectiveness and safety of TQB2102 for injection versus TCbHP in the neoadjuvant treatment of HER2 positive breast cancer patients.
Voluntarily participate in this study, sign the informed consent form, and have good compliance;
Eastern Cooperative Oncology Group performance status (ECOG PS) score: 0-1; expected survival >6 months;
Histologically or cytologically confirmed HER2-positive invasive breast cancer;
Hormone receptor (HR) status confirmed;
Stage IV metastatic breast cancer or other cases judged by the investigator as unsuitable for radical surgical resection after neoadjuvant therapy;
Bilateral breast cancer or inflammatory breast cancer;
History of invasive breast cancer or ductal carcinoma in situ;
Prior anti-tumor therapy for breast cancer, including chemotherapy, endocrine therapy, targeted therapy, radiotherapy, surgery, etc.;
Parallel
TQB2102 for injection
DrugTQB2102 for injection is a HER2 dual-antibody-drug Conjugate (ADC)
Trastuzumab injection and Pertuzumab Injection and Docetaxel Injection and Carboplatin Injection
DrugTCbHP is a commonly used chemotherapy scheme for HER2 positive breast cancer. H represents Trastuzumab injection, P represents Pertuzumab Injection, T represents Docetaxel injection and C represents Carboplatin injection.
Rate of total physiological complete response (tpCR) evaluated by Independent Review Committee (IRC)
Rate of subjects with no residual invasive cancer in the primary breast lesion and negative regional lymph nodes upon microscopic examination after primary tumor resection, as assessed by IRC.
Rate of total physiological complete response (tpCR) evaluated by the investigator
Rate of subjects with no residual invasive cancer in the primary breast lesion and negative regional lymph nodes upon microscopic examination after primary tumor resection, as assessed by the investigator.
Breast pathological complete response (bpCR) evaluated by IRC and the investigator
Percentage of subjects with no residual invasive cancer in the primary breast lesion upon microscopic examination after primary tumor resection, as assessed by IRC and the investigator.
Objective response rate (ORR)
The percentage of subjects achieving complete response (CR) or partial response (PR) as assessed by the investigator based on the Response Evaluation Criteria In Solid Tumors (RECIST 1.1) .
There year Event-free survival (EFS)
Time from randomization to the first occurrence of any of the following events: ipsilateral or contralateral invasive breast cancer recurrence, regional or distant invasive breast cancer recurrence, or death from any cause.
Click on the lead sponsor to view all of their trials.
