Real-world Study of Inetetamab in HER2-positive Metastatic Breast Cancer

Completed

• Conditions: HER2-positive Metastatic Breast Cancer

• Registration Number: NCT06305702
• Lead Sponsor: Liaoning Tumor Hospital & Institute

Brief Summary

A multicenter real-world study was conducted to gather clinicopathological data from patients with HER2-positive metastatic breast cancer who were treated with inetetamab between 2022 and 2023. The study aimed to estimate the progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), and adverse events (AEs) associated with inetetamab therapy.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-01
• Primary Completion: 2023-12-31
• Study Completion: 2024-01-31
• Status Verified: 2024-02
• Study First Submitted: 2024-03-05
• Study First Submitted QC: 2024-03-05
• Last Update Submitted: 2024-03-05
• Study First Posted: 2024-03-12
• Last Update Posted: 2024-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 500

Inclusion Criteria

1. An age of at least 18 years or older
2. Pathologically diagnosed with HER2-positive recurrent or metastatic breast cancer
3. Having at least one measurable lesion as defined
4. Receiving inetetamab-based therapy in the recurrent or metastatic stage
5. Having traceable medical history records

Exclusion Criteria

1. Pregnant or lactating women
2. Patients with other conditions deemed unsuitable for participating in this study by the researcher

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression Free Survival(PFS)	12 months

Secondary Outcome Measures

Name	Time	Method
objective response rate (ORR)	12 months
Adverse events (AEs)	12 months

Trial Locations

Locations (1)

Liaoning Cancer Hospital &Institue; 🇨🇳 Shenyang, China