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Trial Title:
Inetetamab Combined With Pyrotinib Plus Oral Vinorelbine for the Treatment of HER2-positive Metastatic Breast Cancer
NCT ID:
NCT05823623
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Vinorelbine
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Inetetamab
Description:
Patients with HER2-positive metastatic breast cancer after progression on trastuzumab are
enrolled and receive treatment.
Arm group label:
Inetetamab combined with Pyrotinib plus Oral Vinorelbine
Intervention type:
Drug
Intervention name:
Pyrotinib
Description:
Patients with HER2-positive metastatic breast cancer after progression on trastuzumab are
enrolled and receive treatment.
Arm group label:
Inetetamab combined with Pyrotinib plus Oral Vinorelbine
Intervention type:
Drug
Intervention name:
Oral Vinorelbine Tartrate
Description:
Patients with HER2-positive metastatic breast cancer after progression on trastuzumab are
enrolled and receive treatment.
Arm group label:
Inetetamab combined with Pyrotinib plus Oral Vinorelbine
Summary:
In this phase 2 single-arm clinical trial, 30 patients with HER2-positive metastatic
breast cancer after progression on trastuzumab are enrolled and receive treatment of
Inetetamab plus Pyrotinib plus Oral Vinorelbine. The study aimed to access the efficacy
and safety of Inetetamab combined with Pyrotinib and Oral Vinorelbine in HER2-positive
metastatic breast cancer patients after progression on trastuzumab.
Detailed description:
Trastuzumab is an important agent for the treatment of patients with HER2-positive
metastatic breast cancer. However, a considerable number of patients will develop
resistance to trastuzumab treatment. Previous studies have shown that multiple mechanisms
mediate trastuzumab resistance, such as abnormal extracellular domain of the HER2
receptor, HER3 mutation and activation of bypass signaling pathway. To overcome these
resistance mechanisms, the combination of trastuzumab with HER2-targeting tyrosine kinase
inhibitor (TKI) is an effective strategy. In this phase 2 single-arm clinical trial, 30
patients with HER2-positive metastatic breast cancer after progression on trastuzumab are
enrolled and receive treatment of Inetetamab plus Pyrotinib plus Oral Vinorelbine. The
study aimed to access the efficacy and safety of Inetetamab combined with Pyrotinib and
Oral Vinorelbine in HER2-positive metastatic breast cancer patients after progression on
trastuzumab. The primary end point is Progressive-free Survival (PFS). The secondary end
points are Overall Survival (OS), Overall Response Rate (ORR), Clinical Benefit Rate
(CBR) and safety.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Female, Aged ≥ 18 years.
2. Metastatic breast cancer confirmed by pathology or imaging.
3. Pathological diagnosis of HER2 positive (definition: immunohistochemical (IHC) 3+,
or IHC 2+ with in situ hybridization (ISH) testing of amplification.
4. Previously received trastuzumab treatment.
5. At least one Measurable target lesion according to RECIST 1.1.
6. Eastern Cooperative Oncology Group (ECOG) score 0- 2.
7. Sufficient organ function: Neutrophil count (ANC) ≥ 1.5 × 10 ^ 9 / L, Platelet count
(PLT) ≥ 100 × 10 ^ 9 / L, hemoglobin (Hb) ≥90 g/L，total bilirubin (TBIL) ≤ 1.5 ×
upper limit of normal value (ULN), alanine aminotransferase (ALT / AST) ≤ 2.5 × ULN
(liver metastasis patients ≤ 5×ULN), serum creatinine ≤ 1.5 × ULN or creatinine
clearance rate (CCR) ≥ 60 ml/min, Left ventricular ejection fraction (LVEF) ≥50%.
Exclusion Criteria:
1. Allergic to the ingredients of the study drug.
2. Symptomatic brain or meningeal metastasis.
3. Gastrointestinal dysfunction or gastrointestinal diseases (including active ulcers).
4. LVEF <50%; clinical manifestations of patients with obvious arrhythmia, myocardial
ischemia, severe atrioventricular block, cardiac insufficiency, and severe valvular
disease.
5. Any other medical, social or psychological conditions which are inappropriate to
participate in this trial.
6. Pregnant or lactating women, women of childbearing age who refused to take effective
contraceptive measures during the study period.
Gender:
Female
Minimum age:
18 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital with Nanjing Medical University
Address:
City:
Nanjing
Zip:
210029
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiang Huang
Phone:
+8613701473675
Email:
lorelai@njmu.edu.cn
Start date:
February 13, 2022
Completion date:
December 2025
Lead sponsor:
Agency:
The First Affiliated Hospital with Nanjing Medical University
Agency class:
Other
Source:
The First Affiliated Hospital with Nanjing Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05823623
