Neoadjuvant Study of Navelbine in Patients With HER2 Positive Breast Cancer

• Status: Not yet recruiting
• Trial end date: 2023-02-28
• Target enrollment: 0
• Participant gender: Female

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 given as neoadjuvant treatment in HER2 positive early-stage or locally advanced breast cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhejiang Cancer Hospital
• Treatments: Docetaxel; Vinorelbine

Criteria

Inclusion Criteria:

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 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.