Neoadjuvant Study of Navelbine in Patients With HER2 Positive Breast Cancer
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
1 other identifier
interventional
50
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 breast-cancer
Started Mar 2021
Shorter than P25 for phase_3 breast-cancer
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 7, 2020
CompletedFirst Posted
Study publicly available on registry
December 14, 2020
CompletedStudy Start
First participant enrolled
March 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2023
CompletedDecember 14, 2020
December 1, 2020
12 months
December 7, 2020
December 7, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
pCR
Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery.
Through study completion, an average of 1 year
Secondary Outcomes (3)
DFS
Following surgery until Year 3
DDFS
Following surgery until Year 3
ORR
Baseline up to cycle 4 (assessed at Baseline, at the time of pre-surgery)up to approximately 12 months
Study Arms (2)
NHP
EXPERIMENTALNavelbine, Herceptin, Pertuzumab
THP
ACTIVE COMPARATORDocetaxel, Herceptin, Pertuzumab
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 7, 2020
First Posted
December 14, 2020
Study Start
March 1, 2021
Primary Completion
February 28, 2022
Study Completion
February 28, 2023
Last Updated
December 14, 2020
Record last verified: 2020-12