NCT03588091

Neoadjuvant Study of Pyrotinib in Combination With Trastuzumab in Patients With HER2 Positive Breast Cancer

A Randomized, Muticenter Double-blind Phase III Study of Neoadjuvant Pyrotinib Plus Trastuzumab and Docetaxel Compared With Placebo Plus Trastuzumab and Docetaxel in Women With HER2 Positive Early Stage or Locally Advanced Breast Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 355 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a randomised, double-blind multicenter Phase III study for evaluating the efficacy and safety of neoadjuvant pyrotinib and trastuzumab plus docetaxel versus placebo and trastuzumab plus docetaxel given as neoadjuvant treatment in HER2 positive early stage or locally advanced breast cancer.

Conditions

• HER2-positive Breast Cancer

Interventions

Type	Name	Description
DRUG	Pyrotinib	pyrotinib: 400mg orally daily;
DRUG	Placebo Oral Tablet	placebo: 400mg orally daily;
DRUG	Trastuzumab	trastuzumab:8mg/kg iv load followed by 6mg/kg iv 3-weekly for a total of 4 cycles;
DRUG	Docetaxel	docetaxel:after the biological window, 100mg/m2 for a total of 4 cycles

Timeline

• Start date: 2018-07-24
• Primary completion: 2024-01-31
• Completion: 2024-01-31
• First posted: 2018-07-17
• Last updated: 2025-08-22

Locations

17 sites across 1 country: China

Regulatory

• FDA-regulated drug study