Neoadjuvant Study of Pyrotinib in Combination With Trastuzumab in Patients With HER2 Positive Breast Cancer
NCT ID: NCT03588091
Last Updated: 2025-08-22
Study Results
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Basic Information
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COMPLETED
PHASE3
355 participants
INTERVENTIONAL
2018-07-24
2024-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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arm1
Pyrotinib Plus trastuzumab and docetaxel
Pyrotinib
pyrotinib: 400mg orally daily;
Trastuzumab
trastuzumab:8mg/kg iv load followed by 6mg/kg iv 3-weekly for a total of 4 cycles;
Docetaxel
docetaxel:after the biological window, 100mg/m2 for a total of 4 cycles
arm2
placebo plus trastuzumab and docetaxel
Placebo Oral Tablet
placebo: 400mg orally daily;
Trastuzumab
trastuzumab:8mg/kg iv load followed by 6mg/kg iv 3-weekly for a total of 4 cycles;
Docetaxel
docetaxel:after the biological window, 100mg/m2 for a total of 4 cycles
Interventions
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Pyrotinib
pyrotinib: 400mg orally daily;
Placebo Oral Tablet
placebo: 400mg orally daily;
Trastuzumab
trastuzumab:8mg/kg iv load followed by 6mg/kg iv 3-weekly for a total of 4 cycles;
Docetaxel
docetaxel:after the biological window, 100mg/m2 for a total of 4 cycles
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
FEMALE
No
Sponsors
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Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Peking University People's Hospital
Beijing, Beijing Municipality, China
The Fifth Medical Center of Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Sun Yet-Sen University Cancer Center
Guangzhou, Guangdong, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The affiliated cancer hospital of Zhengzhou University & Henan Cancer Hospital
Zhengzhou, Henan, China
Huai'an First People's Hospital
Huaian, Jiangsu, China
JiangSu Province Hospital
Nanjing, Jiangsu, China
Shandong Cancer Hospital
Jinan, Shandong, China
The Affiliated Hospital Of Qingdao University
Qingdao, Shandong, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
The Second Affiliated Hospital Of Xi'an Jiaotong University
Xian, Shanxi, China
The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Countries
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References
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Wu J, Jiang Z, Liu Z, Yang B, Yang H, Tang J, Wang K, Liu Y, Wang H, Fu P, Zhang S, Liu Q, Wang S, Huang J, Wang C, Wang S, Wang Y, Zhen L, Zhu X, Wu F, Lin X, Zou J. Neoadjuvant pyrotinib, trastuzumab, and docetaxel for HER2-positive breast cancer (PHEDRA): a double-blind, randomized phase 3 trial. BMC Med. 2022 Dec 27;20(1):498. doi: 10.1186/s12916-022-02708-3.
Other Identifiers
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HR-BLTN-III-NeoBC
Identifier Type: -
Identifier Source: org_study_id
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