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.

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.

Timeline

Start

2020-10-20

Primary completion

2023-01-08

Completion

2023-12

Publications

• Xu D, Wu J, Yu J, Yang Y, Wen X, Yang J, Wei H, Xu X, Li Y, Yang L, Wang L, Wang Y, Ma W, Li N. A historical controlled study of domestic trastuzumab and pertuzumab in combination with docetaxel for the neoadjuvant treatment of early HER2-positive breast cancer. Front Oncol. 2024 Feb 9;14:1281643. doi: 10.3389/fonc.2024.1281643. eCollection 2024.

Drugs

Indications