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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04665986

Enrollment

Registered

2020-12-14

Start date

2021-03-01

Completion date

2023-02-28

Last updated

2020-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

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.

Interventions

DRUGNavelbine

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

DRUGDocetaxel

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026