Clinical Trials/NCT03588091

NCT03588091

Completed

Phase 3

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

Jiangsu HengRui Medicine Co., Ltd.17 sites in 1 country355 target enrollmentJuly 24, 2018

ConditionsHER2-positive Breast Cancer

InterventionsPyrotinib Trastuzumab Docetaxel Placebo Oral Tablet

DrugsPyrotinib Placebo Oral Tablet Trastuzumab Docetaxel

Overview

Phase: Phase 3
Intervention: Pyrotinib
Conditions: HER2-positive Breast Cancer
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Enrollment: 355
Locations: 17
Primary Endpoint: Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery evaluated by independent review committee(IRC)
Status: Completed
Last Updated: 8 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

July 24, 2018

End Date

January 31, 2024

Last Updated

8 months ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Responsible Party

Sponsor

Eligibility 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.

Arms & Interventions

arm1

Pyrotinib Plus trastuzumab and docetaxel

Intervention: Pyrotinib

arm1

Pyrotinib Plus trastuzumab and docetaxel

Intervention: Trastuzumab

arm1

Pyrotinib Plus trastuzumab and docetaxel

Intervention: Docetaxel

arm2

placebo plus trastuzumab and docetaxel

Intervention: Placebo Oral Tablet

arm2

placebo plus trastuzumab and docetaxel

Intervention: Trastuzumab

arm2

placebo plus trastuzumab and docetaxel

Intervention: Docetaxel

Outcomes

Primary Outcomes

Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery evaluated by independent review committee(IRC)

Time Frame: through study completion, an average of 1 year

Secondary Outcomes

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)