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

NCT05823623 | Unknown Phase 2

• 1 other identifier: 2022-SR-494
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival，PFS

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

  2 years

Secondary Outcomes (4)

• overall survival，OS

  4 years

• Objective Response Rate，ORR

  2 year

• Clinical Benefit Rate，CBR

  2 year

• adverse events

  2 years

Other Outcomes (1)

• Exploration of biomarkers

  1 year

Study Arms (1)

Inetetamab combined with Pyrotinib plus Oral Vinorelbine

EXPERIMENTAL

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.

Drug: Inetetamab; Drug: Pyrotinib; Drug: Oral Vinorelbine Tartrate

Interventions

Inetetamab DRUG

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

Inetetamab combined with Pyrotinib plus Oral Vinorelbine

Pyrotinib DRUG

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

Inetetamab combined with Pyrotinib plus Oral Vinorelbine

Oral Vinorelbine Tartrate DRUG

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

Inetetamab combined with Pyrotinib plus Oral Vinorelbine

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 210029, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 38328709 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

pyrotinib; Vinorelbine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Xiang Huang

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiang Huang

CONTACT

+8613701473675; lorelai@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: April 21, 2023
• Study Start: February 13, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2025
• Last Updated: September 14, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)