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

NCT ID: NCT05823623

Last Updated: 2023-09-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-13
• Study Completion Date: 2025-12-31

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Inetetamab combined with Pyrotinib plus Oral Vinorelbine

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.

Group Type: EXPERIMENTAL

Inetetamab

Intervention Type: DRUG

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

Pyrotinib

Intervention Type: DRUG

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

Oral Vinorelbine Tartrate

Intervention Type: DRUG

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

Interventions

Inetetamab

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

Intervention Type: DRUG

Pyrotinib

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

Intervention Type: DRUG

Oral Vinorelbine Tartrate

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiang Huang

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital with Nanjing Medical University

Locations

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiang Huang

Role: CONTACT

lorelai@njmu.edu.cn

+8613701473675

Facility Contacts

Xiang Huang

Role: primary

lorelai@njmu.edu.cn

+8613701473675

References

Jin N, Xu Y, Wang S, Sun C, Yan X, Yang F, Liang Y, Chen W, Huang X. Inetetamab combined with pyrotinib and oral vinorelbine for patients with human epidermal growth factor receptor 2 positive advanced breast cancer: A single-arm phase 2 clinical trial. Cancer Pathog Ther. 2023 Oct 30;2(1):31-37. doi: 10.1016/j.cpt.2023.10.004. eCollection 2024 Jan.

Reference Type: DERIVED

PMID: 38328709 (View on PubMed)

Other Identifiers

2022-SR-494

Identifier Type: -

Identifier Source: org_study_id