Neoadjuvant Study of Navelbine in Patients With HER2 Positive Breast Cancer

Zhejiang Cancer Hospital50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Breast Cancer

Interventions

NavelbineDRUG

Navelbine 25mg/m2 on day 1 and 8, every 3 weeks

DocetaxelDRUG

Docetaxel 90mg/m2 on day 1, every 3 weeks

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

pCR

Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery.

Time frame: Through study completion, an average of 1 year

Secondary Outcomes

DFS

Disease-free Survival

Time frame: Following surgery until Year 3

DDFS

Distance Disease-free Survival

Time frame: Following surgery until Year 3

ORR

Objective Response Rate

Time frame: Baseline up to cycle 4 (assessed at Baseline, at the time of pre-surgery)up to approximately 12 months

Data from ClinicalTrials.gov

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