Clinical Study to Evaluate the Efficacy and Safety of TQB2440 Injection/Perjeta® Combined With Trastuzumab and Docetaxel in the Treatment of Patients With Early or Locally Advanced Breast Cancer.

PHASE3UnknownINTERVENTIONAL
Enrollment

412

Participants

Timeline

Start Date

October 20, 2020

Primary Completion Date

January 8, 2023

Study Completion Date

December 31, 2023

Conditions
HER2-positive Breast Cancer
Interventions
DRUG

TQB2440 injection + Trastuzumab + Docetaxel

"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."

DRUG

Perjeta + Trastuzumab + Docetaxel

"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."

Trial Locations (6)

150001

Sun Yat-sen University Cancer Prevention Center, Guangzhou

Affiliated cancer hospital of harbin medical university, Harbin

300201

Tianjin Medical University Cancer Hospital, Tianjin

400000

The First Affiliated Hospital of Chongqing Medical University, Chongqing

710000

The First Affiliated Hospital of PLA Air Force Medical University, Xi'an

The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an

All Listed Sponsors
lead

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

INDUSTRY