NCT04963608

Brief Summary

This non-Interventional study will describe and analyze the clinical use of Inetetamab in clinical practice in the treatment of HER2 positive advanced breast cancer in the real world.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2021

Shorter than P25 for all trials

Status
unknown

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, 2021

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

July 11, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 15, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

July 15, 2021

Status Verified

July 1, 2021

Enrollment Period

5 months

First QC Date

July 11, 2021

Last Update Submit

July 14, 2021

Conditions

HER2-positive Advanced Breast Cancer

Outcome Measures

Primary Outcomes (2)

  • Progression Free Survival(PFS)

    12 months

  • Incidences of adverse events and toxicities

    12 months

Study Arms (1)

non-interventional study

Her2 positive ABC patients who have received Inetetamab in the metastatic setting.

Drug: Inetetamab

Interventions

InetetamabDRUG

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

non-interventional study

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

HER2+ advanced breast cancer patients whose treatment decision with Inetetamab has been made by their physician and who meet the eligibility criteria will be invited to participate in the study

You may qualify if:

  • Patients with stage IV breast cancer
  • Patients with HER2 positive status
  • Patients that received Inetetamab
  • Patients that began Inetetamab therapy prior to June 30, 2021.

You may not qualify if:

  • Patients treated with an investigational anticancer agent Inetetamab

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Zhiyong yu

CONTACT

86-13355312277drzhiyongyu@aliyun.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief of breast department

Study Record Dates

First Submitted

July 11, 2021

First Posted

July 15, 2021

Study Start

July 1, 2021

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

July 15, 2021

Record last verified: 2021-07