Inetetamab Combined With Pyrotinib Plus Oral Vinorelbine for the Treatment of HER2-positive Metastatic Breast Cancer

The First Affiliated Hospital with Nanjing Medical University30 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

InetetamabDRUG

Patients with HER2-positive metastatic breast cancer after progression on trastuzumab are enrolled and receive treatment.

PyrotinibDRUG

Patients with HER2-positive metastatic breast cancer after progression on trastuzumab are enrolled and receive treatment.

Oral Vinorelbine TartrateDRUG

Patients with HER2-positive metastatic breast cancer after progression on trastuzumab are enrolled and receive treatment.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

RECRUITING

Outcomes

Primary Outcomes

Progression Free Survival，PFS

The time from the beginning of treatment to the progression or death of the patient

Time frame: 2 years

Secondary Outcomes

overall survival，OS

The time from the beginning of treatment to the death of the patient

Time frame: 4 years

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)

Time frame: 2 year

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

Time frame: 2 year

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.

Time frame: 2 years

Central Contacts

Xiang Huang

CONTACT

+8613701473675 lorelai@njmu.edu.cn

Data from ClinicalTrials.gov

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