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

Hengrui Medicine

Status and phase: Completed; Phase 3

Conditions: HER2-positive Breast Cancer

Treatments: Drug: Pyrotinib; Drug: Placebo Oral Tablet; Drug: Trastuzumab; Drug: Docetaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT03588091

HR-BLTN-III-NeoBC

Details and patient eligibility

About

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.

Enrollment: 355 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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355 participants in 2 patient groups, including a placebo group

arm1

Experimental group

Description:

Pyrotinib Plus trastuzumab and docetaxel

Treatment:

Drug: Docetaxel

Drug: Trastuzumab

Drug: Pyrotinib

arm2

Placebo Comparator group

Description:

placebo plus trastuzumab and docetaxel

Treatment:

Drug: Docetaxel

Drug: Trastuzumab

Drug: Placebo Oral Tablet