Treatment for HER2-positive metastatic breast cancer using Inetetamab, Pyrotinib, and Oral Vinorelbine

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

This study is testing a new combination of drugs for people with HER2-positive metastatic breast cancer who haven't responded to previous treatment to see if it can help them live longer without their cancer getting worse.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 85 Years
• Sex: Female
• Sponsor: The First Affiliated Hospital with Nanjing Medical University (Academic / other)
• Drugs / interventions: trastuzumab, Inetetamab, Pyrotinib
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT05823623 on ClinicalTrials.gov

What this trial studies

This phase 2 single-arm clinical trial enrolls 30 patients with HER2-positive metastatic breast cancer who have progressed after treatment with trastuzumab. Participants will receive a combination of Inetetamab, Pyrotinib, and Oral Vinorelbine to evaluate the efficacy and safety of this treatment regimen. The primary endpoint is progression-free survival, while secondary endpoints include overall survival, overall response rate, clinical benefit rate, and safety assessments. The study aims to address resistance mechanisms to trastuzumab and improve outcomes for patients with this aggressive cancer type.

Who should consider this trial

Good fit: Ideal candidates are women aged 18 and older with confirmed HER2-positive metastatic breast cancer who have previously received trastuzumab.

Not a fit: Patients with symptomatic brain or meningeal metastasis or those allergic to the study drugs may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with HER2-positive metastatic breast cancer who have not responded to trastuzumab.

How similar studies have performed: Previous studies have shown promise in combining HER2-targeting therapies with other agents to overcome resistance, suggesting this approach may be effective.

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.

Where this trial is running

Nanjing, Jiangsu

• The First Affiliated Hospital with Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Principal investigator: Xiang Huang — The First Affiliated Hospital with Nanjing Medical University
• Study coordinator: Xiang Huang

Conditions Breast Cancer