NCT05594082

Brief Summary

The aim of this trial is to explore the real-world effectiveness and poteintial predictors in Chinese metastatic breast cancer patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

November 1, 2021

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

October 26, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

April 4, 2023

Status Verified

March 1, 2023

Enrollment Period

2.7 years

First QC Date

October 8, 2022

Last Update Submit

March 31, 2023

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • PFS

    progression-free survival

    6 weeks

Secondary Outcomes (4)

  • ORR

    6 weeks

  • CBR

    6 weeks

  • OS

    6 weeks

  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    6 weeks

Interventions

Trastuzumab DeruxtecanDRUG

Trastuzumab Deruxtecan, 5.4 mg/kg ivgtt q3w

Eligibility Criteria

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

Chinese metastatic breast cancer patients

You may qualify if:

  • Patients aged over 18 years old.
  • Metastatic breast cancer included unresectable locally advanced breast cancer, de novo stage IV breast cancer, and recurrent metastatic breast cancer.
  • Plan to receive or has received Trastuzumab Deruxtecan monotherapy
  • Available medical history.

You may not qualify if:

  • Incomplete medical history.
  • Pregnancy or breast-breeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

trastuzumab deruxtecan

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 8, 2022

First Posted

October 26, 2022

Study Start

November 1, 2021

Primary Completion

July 1, 2024

Study Completion

July 1, 2024

Last Updated

April 4, 2023

Record last verified: 2023-03

Locations

CN(1)