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

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.

Study Overview

• Status: Completed
• Conditions: HER2-positive Breast Cancer
• Intervention / Treatment: Drug: Pyrotinib; Drug: Trastuzumab; Drug: Docetaxel; Drug: Placebo Oral Tablet

• Study Type: Interventional
• Enrollment (Actual): 355
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • Peking University People's Hospital
    • Beijing, Beijing, China, 100071
      • The Fifth Medical Center of Chinese PLA General Hospital
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Fujian Medical University Union Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Guangdong Provincial People's Hospital
    • Guangzhou, Guangdong, China, 510010
      • Sun Yet-sen University Cancer Center
    • Guangzhou, Guangdong, China, 510289
      • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
  • Hebei
    • Shijiazhuang, Hebei, China, 050000
      • The Fourth Hospital of Hebei Medical University
  • Henan
    • Zhengzhou, Henan, China, 450000
      • The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
  • Jiangsu
    • Huaian, Jiangsu, China, 223001
      • Huai'an first people's hospital
    • Nanjing, Jiangsu, China, 210029
      • Jiangsu Province Hospital
  • Shandong
    • Jinan, Shandong, China, 250000
      • Shandong Cancer Hospital
    • Qingdao, Shandong, China, 266100
      • The Affiliated Hospital Of Qingdao University
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Fudan University Shanghai Cancer Center
  • Shanxi
    • Xian, Shanxi, China, 710004
      • The Second Affiliated Hospital of Xi'an Jiaotong University
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • The First Affiliated Hospital Zhejiang University School Of Medicine
    • Hangzhou, Zhejiang, China, 310005
      • Zhejiang Cancer Hospital
    • Hangzhou, Zhejiang, China, 310009
      • The Second Affiliated Hospital Zhejiang University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• female patients, 18 years ≤ age ≤ 75 years；
• Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1
• Histologically confirmed invasive breast cancer（early stage or locally advanced）:Primary tumour greater than 2 cm diameter
• HER2 positive (HER2+++ by IHC or FISH+)
• Known hormone receptor status.
• Cardiovascular:Baseline left ventricular ejection fraction (LVEF)≥55% measured by ECHO
• Signed informed consent form (ICF)

Exclusion Criteria:

• metastatic disease (Stage IV) or inflammatory breast cancer
• Previous or current history of malignant neoplasms, except for curatively treated:Basal and squamous cell carcinoma of the skin,Carcinoma in situ of the cervix.
• clinically relevant cardiovascular disease:Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110);
• Unable or unwilling to swallow tablets.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: arm1; Pyrotinib Plus trastuzumab and docetaxel	Drug: Pyrotinib; pyrotinib: 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
Placebo Comparator: arm2; placebo plus trastuzumab and docetaxel	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; Drug: Placebo Oral Tablet; placebo: 400mg orally daily;

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery evaluated by independent review committee(IRC)	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery evaluated by sites	Approximately 4 months from randomization following surgery or early withdrawal, whichever occurred first (Surgery was performed within 2 weeks after Cycle 4,each cycle is 21 days)
Event-free survival(EFS)	Following surgery until Year 3
Disease-free Survival (DFS)	Following surgery until Year 3
Distance Disease-free Survival (DDFS)	Following surgery until Year 3
Objective Response Rate (ORR) during neoadjuvant period	Baseline up to cycle 4 (assessed at Baseline, at the time of pre-surgery)up to approximately 12 months

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2018
• Primary Completion (Actual): January 31, 2024
• Study Completion (Actual): January 31, 2024

Study Registration Dates

• First Submitted: June 18, 2018
• First Submitted That Met QC Criteria: July 3, 2018
• First Posted (Actual): July 17, 2018

Study Record Updates

• Last Update Posted (Actual): August 22, 2025
• Last Update Submitted That Met QC Criteria: August 21, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms; Antineoplastic Agents, Immunological; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel; Trastuzumab
• Other Study ID Numbers: HR-BLTN-III-NeoBC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No