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OpenTrials
Completed

NCT Number: NCT06305702

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

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.

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Key information

Conditions

HER2-Positive Metastatic Breast Cancer

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Liaoning Cancer Hospital &Institue

Shenyang, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Inetetamab

Drug

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

Primary outcomes

  1. Progression Free Survival(PFS)

    Time frame: 12 months

Secondary outcomes

  1. objective response rate (ORR)

    Time frame: 12 months

  2. Adverse events (AEs)

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Liaoning Cancer Hospital & Institute

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Mar 12, 2024
Registry last updated
Mar 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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