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

• Status: Active, not recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Treatments: Docetaxel; Trastuzumab

Criteria

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.