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.

NCT05985187 Phase 3 UNKNOWN

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.

Details

Lead sponsor	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Phase	Phase 3
Status	UNKNOWN
Enrolment	412
Start date	2020-10-20
Completion	2023-12

Conditions

• HER2-positive Breast Cancer

Interventions

• TQB2440 injection + Trastuzumab + Docetaxel
• Perjeta + Trastuzumab + Docetaxel

Primary outcomes

• Overall pathological complete response (tpCR) rate assessed by Independent review committee (IRC). — Baseline up to 4 months.
  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.

Countries

China