Back to resultsInetetamab Combined With Pyrotinib Plus Oral Vinorelbine for the Treatment of HER2-positive Metastatic Breast Cancer
Primary Purpose
Breast Cancer
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Inetetamab
Pyrotinib
Oral Vinorelbine Tartrate
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria: Female, Aged ≥ 18 years. Metastatic breast cancer confirmed by pathology or imaging. Pathological diagnosis of HER2 positive (definition: immunohistochemical (IHC) 3+, or IHC 2+ with in situ hybridization (ISH) testing of amplification. Previously received trastuzumab treatment. At least one Measurable target lesion according to RECIST 1.1. Eastern Cooperative Oncology Group (ECOG) score 0- 2. 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: Allergic to the ingredients of the study drug. Symptomatic brain or meningeal metastasis. Gastrointestinal dysfunction or gastrointestinal diseases (including active ulcers). LVEF <50%; clinical manifestations of patients with obvious arrhythmia, myocardial ischemia, severe atrioventricular block, cardiac insufficiency, and severe valvular disease. Any other medical, social or psychological conditions which are inappropriate to participate in this trial. Pregnant or lactating women, women of childbearing age who refused to take effective contraceptive measures during the study period.
Sites / Locations
- The First Affiliated Hospital with Nanjing Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Inetetamab combined with Pyrotinib plus Oral Vinorelbine
Arm Description
Inetetamab: 8mg/kg for the first dose, 6mg/kg for the following doses, intravenous, every 3 weeks for one cycle. Pyrotinib: 400mg, oral, every day. Vinorelbine: 60mg/m2, oral, every week.
Outcomes
Primary Outcome Measures
Progression Free Survival，PFS
The time from the beginning of treatment to the progression or death of the patient
Secondary Outcome Measures
overall survival，OS
The time from the beginning of treatment to the death of the patient
Objective Response Rate，ORR
The percentage of participants whose best overall response, according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1, is either complete response (CR) or partial response (PR)
Clinical Benefit Rate，CBR
the percentage of participants whose best overall response, is either CR, PR or stable disease (SD) lasting for at least 24 weeks
adverse events
The probability and severity of adverse reactions related to the treatment were assessed by CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) v5.0.
Full Information
NCT ID
NCT05823623
First Posted
March 23, 2023
Last Updated
September 13, 2023
Sponsor
The First Affiliated Hospital with Nanjing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05823623
Brief Title
Inetetamab Combined With Pyrotinib Plus Oral Vinorelbine for the Treatment of HER2-positive Metastatic Breast Cancer
Official Title
A Phase II Single-arm Clinical Trial of Inetetamab Combined With Pyrotinib Plus Oral Vinorelbine for the Treatment of Patients With HER2-positive Metastatic Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 13, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital with Nanjing Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Inetetamab combined with Pyrotinib plus Oral Vinorelbine
Arm Type
Experimental
Arm Description
Inetetamab: 8mg/kg for the first dose, 6mg/kg for the following doses, intravenous, every 3 weeks for one cycle. Pyrotinib: 400mg, oral, every day. Vinorelbine: 60mg/m2, oral, every week.
Intervention Type
Drug
Intervention Name(s)
Inetetamab
Intervention Description
Patients with HER2-positive metastatic breast cancer after progression on trastuzumab are enrolled and receive treatment.
Intervention Type
Drug
Intervention Name(s)
Pyrotinib
Intervention Description
Patients with HER2-positive metastatic breast cancer after progression on trastuzumab are enrolled and receive treatment.
Intervention Type
Drug
Intervention Name(s)
Oral Vinorelbine Tartrate
Intervention Description
Patients with HER2-positive metastatic breast cancer after progression on trastuzumab are enrolled and receive treatment.
Primary Outcome Measure Information:
Title
Progression Free Survival，PFS
Description
The time from the beginning of treatment to the progression or death of the patient
Time Frame
2 years
Secondary Outcome Measure Information:
Title
overall survival，OS
Description
The time from the beginning of treatment to the death of the patient
Time Frame
4 years
Title
Objective Response Rate，ORR
Description
The percentage of participants whose best overall response, according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1, is either complete response (CR) or partial response (PR)
Time Frame
2 year
Title
Clinical Benefit Rate，CBR
Description
the percentage of participants whose best overall response, is either CR, PR or stable disease (SD) lasting for at least 24 weeks
Time Frame
2 year
Title
adverse events
Description
The probability and severity of adverse reactions related to the treatment were assessed by CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) v5.0.
Time Frame
2 years
Other Pre-specified Outcome Measures:
Title
Exploration of biomarkers
Description
To explore the potential biomarkers for the efficacy of combined therapy. The biomarkers will be tested by next-generation sequence
Time Frame
1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female, Aged ≥ 18 years.
Metastatic breast cancer confirmed by pathology or imaging.
Pathological diagnosis of HER2 positive (definition: immunohistochemical (IHC) 3+, or IHC 2+ with in situ hybridization (ISH) testing of amplification.
Previously received trastuzumab treatment.
At least one Measurable target lesion according to RECIST 1.1.
Eastern Cooperative Oncology Group (ECOG) score 0- 2.
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:
Allergic to the ingredients of the study drug.
Symptomatic brain or meningeal metastasis.
Gastrointestinal dysfunction or gastrointestinal diseases (including active ulcers).
LVEF <50%; clinical manifestations of patients with obvious arrhythmia, myocardial ischemia, severe atrioventricular block, cardiac insufficiency, and severe valvular disease.
Any other medical, social or psychological conditions which are inappropriate to participate in this trial.
Pregnant or lactating women, women of childbearing age who refused to take effective contraceptive measures during the study period.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiang Huang
Phone
+8613701473675
Email
lorelai@njmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiang Huang
Organizational Affiliation
The First Affiliated Hospital with Nanjing Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital with Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiang Huang
Phone
+8613701473675
Email
lorelai@njmu.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Inetetamab Combined With Pyrotinib Plus Oral Vinorelbine for the Treatment of HER2-positive Metastatic Breast Cancer
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