Status:
UNKNOWN
Neoadjuvant Study of Navelbine in Patients With HER2 Positive Breast Cancer
Lead Sponsor:
Zhejiang Cancer Hospital
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-80 years
Phase:
PHASE3
Brief Summary
This is a randomized, double-blind multicenter Phase III study for evaluating the efficacy of neoadjuvant Navelbine plus trastuzumab and Pertuzumab versus Docetaxel plus trastuzumab and Pertuzumab giv...
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 :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04665986
Start Date
March 1 2021
End Date
February 28 2023
Last Update
December 14 2020
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