Real-world Study of Inetetamab in HER2-positive Metastati... | NCT06305702

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

NCT06305702

Sponsor

Liaoning Cancer Hospital & Institute

Status

Completed

Last Update Posted

Mar 12, 2024Actual

Enrollment

500Actual

Phase

Not provided

Conditions

HER2-positive Metastatic Breast Cancer

Interventions

inetetamab

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2022Actual

Primary Completion Date

Dec 31, 2023Actual

Completion Date

Jan 31, 2024Actual

First Submitted Date

Mar 5, 2024

First Submission Date that Met QC Criteria

Mar 5, 2024

First Posted Date

Mar 12, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 5, 2024

Last Update Posted Date

Mar 12, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
inetetamab	Drug	8mg/kg iv day 1 followed by 6mg/kg iv day 1, cycled every 21 days

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression Free Survival(PFS)		12 months

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Liaoning Cancer Hospital &Institue		Shenyang			China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

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

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided