Neoadjuvant Study of Navelbine in Patients With HER2 Positive Breast Cancer


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.

Full Title of Study: “A Study to Evaluate Navelbine in Combination With Trastuzumab Plus Pertuzumab in Patients With HER2 Positive Early Stage or Locally Advanced Breast Cancer in Neoadjuvant Treatment”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: February 28, 2022


  • Drug: Navelbine
    • Navelbine 25mg/m2 on day 1 and 8, every 3 weeks
  • Drug: Docetaxel
    • Docetaxel 90mg/m2 on day 1, every 3 weeks

Arms, Groups and Cohorts

  • Experimental: NHP
    • Navelbine, Herceptin, Pertuzumab
  • Active Comparator: THP
    • Docetaxel, Herceptin, Pertuzumab

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Zhejiang Cancer Hospital
  • Provider of Information About this Clinical Study
    • Sponsor

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