NCT06914661

Brief Summary

This study analyzes the use of DS8201 in the treatment of metastatic breast cancer in the real world by analysis, exploring whether there are differences in effectiveness and safety between real-world conditions and clinical trials.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

First Submitted

Initial submission to the registry

March 31, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 6, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

May 25, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2025

Completed
Last Updated

July 8, 2025

Status Verified

March 1, 2025

Enrollment Period

3 months

First QC Date

March 31, 2025

Last Update Submit

July 7, 2025

Conditions

Breast Cancer MetastaticEfficacy and Safety

Outcome Measures

Primary Outcomes (1)

  • PFS

    Time to disease progression or death from the first receipt of treatment in each line of therapy

    baseline and 1 year

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with metastatic breast cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Hospital of Jilin University

Changchun, Jilin, China

Location

Study Design

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

Study Record Dates

First Submitted

March 31, 2025

First Posted

April 6, 2025

Study Start

May 25, 2025

Primary Completion

August 30, 2025

Study Completion

October 30, 2025

Last Updated

July 8, 2025

Record last verified: 2025-03

Locations

CN(1)