NCT06641544

The Efficacy and Safety of Different Combination Regimens of Inetetamab in First-line Treatment of HER2 Positive Metastatic Breast Cancer

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is to explore the efficacy and safety of the first-line treatment of HER2 positive recurrent/metastatic breast cancer with Inetetamab combined with Pertuzumab or Pyrotinib combined with chemotherapy, hoping to have better clinical benefits and provide a new treatment mode for targeted treatment.

Detailed description

In terms of the anti-HER2 mechanism, the binding sites of Inetetamab and Trastuzumab are located in the extracellular domain IV, while the binding site of Pertuzumab is located in the conserved domain II, inhibiting HER2 phosphorylation and blocking downstream signaling pathways. The binding site of Pyrotinib is located in the intracellular tyrosinase active domain, which competes with ATP to block HER2 autophosphorylation and activation. Inetetamab combined with Pertuzumab "dual target" blocks HER2 dimer formation, while Inetetamab combined with Pyrotinib "dual target" inhibition can produce synergistic enhancement of anti-HER2 effect. This study is to explore the efficacy and safety of the first-line treatment of HER2 positive recurrent/metastatic breast cancer with Inetetamab combined with Pertuzumab or Pyrotinib combined with chemotherapy, hoping to have better clinical benefits and provide a new treatment mode for targeted treatment.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Inetetamab	Group A received Inetetamab+Pertuzumab+TPC, while Group B received Inetetamab+Pyrotinib+TPC.

Timeline

• Start date: 2024-10-17
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2024-10-15
• Last updated: 2024-10-15

Locations

1 site across 1 country: China