NCT04681287

Exploratory Study of Advanced Breast Cancer in HER2 Positive Patients With Failure of Multi-line Therapy Treated by Combination of Inetetamab (Cipterbin) + PD-1 Inhibitor Combined With Utidelone.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: Henan Cancer Hospital · Other Government
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study plans to explore the efficacy and safety of chemotherapy combined with inetetamab and PD-1 inhibitors in HER2 positive advanced breast cancer who failed to receive trastuzumab and TKIs, and explore the dominant population of dual antibody combination to further guide the precise and individualized treatment of advanced HER2 positive breast cancer.

Conditions

• HER2 Positive Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	inetetamab and PD-1 inhibitor combined with chemotherapy.	1. Chemotherapy selected by doctors: albumin bound paclitaxel, vinorelbine, gemcitabine, capecitabine, and aribrin were administered according to clinical routine; 2. The first dose was 8 mg / kg, followed by 6 mg / kg, once every 3 weeks 3. PD-1 inhibitor 200mg D1 every 3 weeks as a cycle Treatment to disease progression or toxicity intolerance, or death from any cause. The efficacy was evaluated every 2 cycles and adverse events were recorded. After 4-6 cycles of treatment, if the patient is intolerable to chemotherapy for any reason, the chemotherapy can be stopped and the combination of inistumab and PD-1 can be continued.

Timeline

• Start date: 2021-04-23
• Primary completion: 2021-11-04
• Completion: 2024-12-30
• First posted: 2020-12-23
• Last updated: 2023-09-25

Locations

1 site across 1 country: China