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

March 5, 2024 updated by: Liaoning Tumor Hospital & Institute

Multicenter Real-world Clinical Study of Inetetamab-based Therapy 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shenyang, China
        • Liaoning Cancer Hospital &Institue

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

HER2 Positive Advanced Breast Cancer patients who have received Inetetamab treatment in the metastatic setting.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression Free Survival(PFS)
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
objective response rate (ORR)
Time Frame: 12 months
12 months
Adverse events (AEs)
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Liaoning Tumor Hospital & Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2022

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

January 31, 2024

Study Registration Dates

First Submitted

March 5, 2024

First Submitted That Met QC Criteria

March 5, 2024

First Posted (Actual)

March 12, 2024

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LZRXN-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Our plan is to disseminate the findings of this trial via peer-reviewed articles.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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