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

NCT ID: NCT06305702

Last Updated: 2024-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-01

Study Completion Date

2024-01-31

Brief Summary

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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

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Conditions

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HER2-positive Metastatic Breast Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Interventions

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inetetamab

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Liaoning Cancer Hospital & Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Liaoning Cancer Hospital &Institue

Shenyang, , China

Site Status

Countries

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China

Other Identifiers

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LZRXN-001

Identifier Type: -

Identifier Source: org_study_id

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