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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
544
TQB2102 for injection is a HER2 dual-antibody-drug Conjugate (ADC)
TCbHP 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.
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, China
NOT_YET_RECRUITINGAnhui Provincial Cancer Hospital
Hefei, Anhui, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Wannan Medical University
Wuhu, Anhui, China
NOT_YET_RECRUITINGPeking Union Medical College Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGRate 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.
Time frame: Up to 26 months after study start
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.
Time frame: Up to 24 months after study start
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.
Time frame: Up to 26 months after study start
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) .
Time frame: Up to 22 months after study start
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.
Time frame: Up to 50 months after study start
There year Invasive Disease-free survival (IDFS)
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.
Time frame: Up to 50 months after study start
Overall Survival (OS)
Time from randomization to death due to any cause.
Time frame: Up to 50 months after study start
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), and indicators of abnormal laboratory tests
To evaluate the safety of TQB2102 for Injection compared to TCbHP in the neoadjuvant treatment of HER2 positive early breast cancer, including: the incidence and severity of adverse events (AEs), abnormal laboratory test values, and serious adverse events (SAEs).
Time frame: From the date of signing the informed consent to 40 days after the last dosing or radical mastectomy for breast cancer or a new anti-tumor treatment, whichever comes first.
Incidence of Anti-drug antibody (ADA) and neutralizing antibodies (NAb)
Incidence of ADA and Nab
Time frame: Up to 22 months after study start
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
NOT_YET_RECRUITINGThe Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
NOT_YET_RECRUITINGThe Cancer Hospital Affiliated to Chongqing University, Chongqing Cancer Hospital, Chongqing Cancer Research Institute, and Chongqing Cancer Center
Chongqing, Chongqing Municipality, China
NOT_YET_RECRUITINGThe First Hospital Affiliated to Army Medical University
Chongqing, Chongqing Municipality, China
NOT_YET_RECRUITINGQuanzhou First Hospital
Quanzhou, Fujian, China
NOT_YET_RECRUITING...and 68 more locations