Status:
UNKNOWN
Neoadjuvant Study of Pyrotinib in Patients With HER2 Positive Breast Cancer
Lead Sponsor:
Zhejiang Cancer Hospital
Conditions:
Breast Cancer
Neoplasm, Breast
Eligibility:
FEMALE
18-80 years
Phase:
NA
Brief Summary
This is a randomized, double-blind multicenter Phase III study for evaluating the efficacy and safety of neoadjuvant pyrotinib and trastuzumab plus docetaxel and Carboplatin versus placebo and trastuz...
Detailed Description
The investigators hypothesized that the experimental group (Pyrotinib+Trastuzumab+Docetaxel+ Carboplatin) could have a higher Pathological Complete Response (pCR) rate than the control group (Placebo ...
Eligibility Criteria
Inclusion
- female patients, 18 years ≤ age ≤ 80 years；
- Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1
- Histologically confirmed invasive breast cancer（early stage or locally advanced）
- 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
- 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.
Key Trial Info
Start Date :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03756064
Start Date
August 1 2019
End Date
July 31 2021
Last Update
August 13 2019
Active Locations (1)
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1
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310000