Back to resultsNeoadjuvant Study of Pyrotinib in Combination With Trastuzumab in Patients With HER2 Positive Breast Cancer
Primary Purpose
HER2-positive Breast Cancer
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Pyrotinib
Placebo Oral Tablet
Trastuzumab
Docetaxel
Sponsored by
About this trial
This is an interventional treatment trial for HER2-positive Breast Cancer
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.
Sites / Locations
- Peking University People's Hospital
- The Fifth Medical Center of Chinese PLA General Hospital
- Fujian Medical University Union Hospital
- Sun Yet-Sen University Cancer Center
- Guangdong Provincial People's Hospital
- Sun Yat-sen Memorial Hospital, Sun Yat-sen University
- The Fourth Hospital of Hebei Medical University
- The affiliated cancer hospital of Zhengzhou University & Henan Cancer Hospital
- Huai'an First People's Hospital
- JiangSu Province Hospital
- Shandong Cancer Hospital
- The Affiliated Hospital Of Qingdao University
- Fudan University Shanghai Cancer Center
- The Second Affiliated Hospital Of Xi'an Jiaotong University
- The First Affiliated Hospital Zhejiang University School of Medicine
- Zhejiang Cancer Hospital
- The Second Affiliated Hospital Zhejiang University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
arm1
arm2
Arm Description
Pyrotinib Plus trastuzumab and docetaxel
placebo plus trastuzumab and docetaxel
Outcomes
Primary Outcome Measures
Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery evaluated by independent review committee(IRC)
Secondary Outcome Measures
Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery evaluated by sites
Event-free survival(EFS)
Disease-free Survival (DFS)
Distance Disease-free Survival (DDFS)
Objective Response Rate (ORR) during neoadjuvant period
Full Information
NCT ID
NCT03588091
First Posted
June 18, 2018
Last Updated
August 3, 2021
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03588091
Brief Title
Neoadjuvant Study of Pyrotinib in Combination With Trastuzumab in Patients With HER2 Positive Breast Cancer
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 24, 2018 (Actual)
Primary Completion Date
April 30, 2021 (Actual)
Study Completion Date
June 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HER2-positive Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
355 (Actual)
8. Arms, Groups, and Interventions
Arm Title
arm1
Arm Type
Experimental
Arm Description
Pyrotinib Plus trastuzumab and docetaxel
Arm Title
arm2
Arm Type
Placebo Comparator
Arm Description
placebo plus trastuzumab and docetaxel
Intervention Type
Drug
Intervention Name(s)
Pyrotinib
Intervention Description
pyrotinib: 400mg orally daily;
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Intervention Description
placebo: 400mg orally daily;
Intervention Type
Drug
Intervention Name(s)
Trastuzumab
Intervention Description
trastuzumab:8mg/kg iv load followed by 6mg/kg iv 3-weekly for a total of 4 cycles;
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
docetaxel:after the biological window, 100mg/m2 for a total of 4 cycles
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery evaluated by sites
Time Frame
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)
Title
Event-free survival(EFS)
Time Frame
Following surgery until Year 3
Title
Disease-free Survival (DFS)
Time Frame
Following surgery until Year 3
Title
Distance Disease-free Survival (DDFS)
Time Frame
Following surgery until Year 3
Title
Objective Response Rate (ORR) during neoadjuvant period
Time Frame
Baseline up to cycle 4 (assessed at Baseline, at the time of pre-surgery)up to approximately 12 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Facility Name
The Fifth Medical Center of Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100071
Country
China
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China
Facility Name
Sun Yet-Sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510010
Country
China
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510289
Country
China
Facility Name
The Fourth Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China
Facility Name
The affiliated cancer hospital of Zhengzhou University & Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Facility Name
Huai'an First People's Hospital
City
Huaian
State/Province
Jiangsu
ZIP/Postal Code
223001
Country
China
Facility Name
JiangSu Province Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Name
Shandong Cancer Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250000
Country
China
Facility Name
The Affiliated Hospital Of Qingdao University
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266100
Country
China
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
The Second Affiliated Hospital Of Xi'an Jiaotong University
City
Xian
State/Province
Shanxi
ZIP/Postal Code
710004
Country
China
Facility Name
The First Affiliated Hospital Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310005
Country
China
Facility Name
The Second Affiliated Hospital Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
12. IPD Sharing Statement
Learn more about this trial
Neoadjuvant Study of Pyrotinib in Combination With Trastuzumab in Patients With HER2 Positive Breast Cancer
We'll reach out to this number within 24 hrs