NCT06305702

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 5, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 12, 2024

Completed
Last Updated

March 12, 2024

Status Verified

February 1, 2024

Enrollment Period

1.5 years

First QC Date

March 5, 2024

Last Update Submit

March 5, 2024

Conditions

HER2-positive Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Progression Free Survival(PFS)

    12 months

Secondary Outcomes (2)

  • objective response rate (ORR)

    12 months

  • Adverse events (AEs)

    12 months

Interventions

inetetamabDRUG

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

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liaoning Cancer Hospital &Institue

Shenyang, China

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2024

First Posted

March 12, 2024

Study Start

July 1, 2022

Primary Completion

December 31, 2023

Study Completion

January 31, 2024

Last Updated

March 12, 2024

Record last verified: 2024-02

Locations

CN(1)