Neoadjuvant Study of Navelbine in Patients With HER2 Positive Breast Cancer
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.
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
Interventions
- 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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