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NCT06305702 Clinical Trial

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

HER2-positive Metastatic Breast Cancer Clinical Trial

Official title:
Multicenter Real-world Clinical Study of Inetetamab-based Therapy in HER2-positive Metastatic Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06305702
Other study ID # LZRXN-001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 1, 2022
Est. completion date January 31, 2024

Study information
Verified date February 2024
Source Liaoning Tumor Hospital & Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 500
Est. completion date January 31, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• inetetamab
8mg/kg iv day 1 followed by 6mg/kg iv day 1, cycled every 21 days

Locations
Country Name City State
China Liaoning Cancer Hospital &Institue Shenyang

Sponsors (1)
Lead Sponsor Collaborator
Liaoning Tumor Hospital & Institute

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Progression Free Survival(PFS) 12 months
Secondary objective response rate (ORR) 12 months
Secondary Adverse events (AEs) 12 months
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