Status:
UNKNOWN
Neoadjuvant Study of Pyrotinib and Trastuzumab Plus Chemotherapy in Patients With HER2 Positive Breast Cancer
Lead Sponsor:
Shandong University
Conditions:
HER2-positive Breast Cancer
Eligibility:
FEMALE
18-75 years
Phase:
NA
Brief Summary
This is a prospective, open-label,multicenter Phase II study for evaluating the efficacy and safety of neoadjuvant pyrotinib and trastuzumab plus chemotherapy as neoadjuvant treatment in HER2 positive...
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 (Trastuzu...
Eligibility Criteria
Inclusion
- 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）
- 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 :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2021
Estimated Enrollment :
268 Patients enrolled
Trial Details
Trial ID
NCT03847818
Start Date
March 1 2019
End Date
February 28 2021
Last Update
March 1 2019
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