Neoadjuvant Study of Navelbine in Patients With HER2 Positive Breast Cancer

Phase 3

• Conditions: Breast Cancer
• Interventions: Drug: Docetaxel; Drug: Navelbine

• Registration Number: NCT04665986
• Lead Sponsor: Zhejiang Cancer Hospital

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-12
• Study First Submitted: 2020-12-07
• Study First Submitted QC: 2020-12-07
• Last Update Submitted: 2020-12-07
• Study First Posted: 2020-12-14
• Last Update Posted: 2020-12-14
• Study Start: 2021-03-01
• Primary Completion: 2022-02-28
• Study Completion: 2023-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
THP	Docetaxel	Docetaxel, Herceptin, Pertuzumab
NHP	Navelbine	Navelbine, Herceptin, Pertuzumab

Primary Outcome Measures

Name	Time	Method
pCR	Through study completion, an average of 1 year	Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery.

Secondary Outcome Measures

Name	Time	Method
DFS	Following surgery until Year 3	Disease-free Survival
DDFS	Following surgery until Year 3	Distance Disease-free Survival
ORR	Baseline up to cycle 4 (assessed at Baseline, at the time of pre-surgery)up to approximately 12 months	Objective Response Rate