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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06305702
Enrollment
500
Registered
2024-03-12
Start date
2022-07-01
Completion date
2024-01-31
Last updated
2024-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HER2-positive Metastatic Breast Cancer

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.

Interventions

8mg/kg iv day 1 followed by 6mg/kg iv day 1, cycled every 21 days

Sponsors

Liaoning Cancer Hospital & Institute
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Progression Free Survival(PFS)12 months

Secondary

MeasureTime frame
objective response rate (ORR)12 months
Adverse events (AEs)12 months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026