NCT05985187

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.

A Multicenter, Randomized, Double-blind, Parallel-controlled Clinical 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.

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 412 (actual)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• HER2-positive Breast Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-10-20
• Primary completion: 2023-01-08
• Completion: 2023-12-01
• First posted: 2023-08-14
• Last updated: 2023-08-14

Locations

6 sites across 1 country: China