This is a multicenter, randomized, double-blind, parallel-controlled Phase III study to evaluate the efficacy and safety of TQB2440 injection/Perjeta® combined with trastuzumab and docetaxel in patients with early or locally advanced ER/ PR-negative HER2-positive breast cancer. The trial is scheduled to enroll 412 participants. The sample size was estimated based on 20 treatment cycles and 6 recurrence visits.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
412
TQB2440 injection is a biosimilar of Perjeta® (Pertuzumab injection) developed by Chia Tai Tianqing Pharmaceutical Group. Trastuzumab is a recombinant DNA-derived human IgG monoclonal antibody against P185 glycoprotein regulated by HER2 gene in cell nucleus. Docetaxel is a selective L-type calcium channel blocker. Fluorouracil + epirubicin + cyclophosphamide for 3 cycles is a routine chemotherapy method after neoadjuvant surgery for breast cancer. The combination of Pertuzumab and Trastuzumab will enhance the antitumor activity and is used as the double targeted maintenance.
Perjeta® with the general name Pertuzumab injection, is a recombinant humanized monoclonal antibody targeting the extracellular second domain of human epidermal growth factor receptor 2 (HER2). Trastuzumab is a recombinant DNA-derived human IgG monoclonal antibody against P185 glycoprotein regulated by HER2 gene in cell nucleus. Docetaxel is a selective L-type calcium channel blocker. Fluorouracil + epirubicin + cyclophosphamide for 3 cycles is a routine chemotherapy method after neoadjuvant surgery for breast cancer. The combination of Pertuzumab and Trastuzumab will enhance the antitumor activity and is used as the double targeted maintenance.
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Sun Yat-sen University Cancer Prevention Center
Guangzhou, Guangdong, China
Affiliated cancer hospital of harbin medical university
Harbin, Heilongjiang, China
The First Affiliated Hospital of PLA Air Force Medical University
Xi'an, Shaanxi, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Tianjin Medical University Cancer Hospital
Tianjin, Tianjin Municipality, China
Overall pathological complete response (tpCR) rate assessed by Independent review committee (IRC).
Percentage of subjects with tumor shrinkage reached a complete response assessed by the IRC, defined as no invasive tumor cells in breast and axilla after primary tumor resection.
Time frame: Baseline up to 4 months.
tpCR rate evaluated by the investigators.
Percentage of subjects with tumor shrinkage reached a complete response assessed by the investigators, defined as no invasive tumor cells in breast and axilla after primary tumor resection.
Time frame: Baseline up to 4 months.
Breast pathological complete response (bpCR) rate evaluated by the investigators.
It is defined as no invasive tumor cells in breast examined by microscopy after primary tumor resection, as assessed by the investigators.
Time frame: Baseline up to 4 months.
bpCR assessed by IRC.
It is defined as no invasive tumor cells in breast examined by microscopy after primary tumor resection, as assessed by the IRC.
Time frame: Baseline up to 4 months.
Breast conservation rate
Proportion of patients undergoing breast preservation surgery.
Time frame: Baseline up to 5 months.
Objective remission rate (ORR)
The optimal ORR evaluated by the investigator, including cases with complete response (CR) and partial response (PR).
Time frame: Baseline up to 2 years.
Event-free survival (EFS)
EFS refers to the time interval from randomization to the first recording of the following events: Preoperative disease progression as measured by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Time frame: Baseline up to two years.
Disease free survival (DFS)
DFS refers to the interval between the first day of absence of disease and the first recording of postoperative recurrence of disease or death from any cause, whichever comes first.
Time frame: Baseline up to 2 years.
Overall Survival (OS)
OS indicates the time interval from randomization to death from any cause.
Time frame: Baseline up to 2 years.
Incidence of adverse events
It refer to all adverse medical events that occur after patients or subjects receives an investigational drug, including adverse events (AE), serious adverse events (SAE), and treatment-related adverse events (TEAEs).
Time frame: Baseline up to 2 years.
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