Real-world Effectiveness and Safety Study of T-Dxd in Chinese Metastatic Breast Cancer

March 31, 2023 updated by: Biyun Wang, MD, Fudan University

Real-world Effectiveness and Safety Study of T-Dxd in Chinese Metastatic Breast Cancer.

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Fudan University Shanghai Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Chinese metastatic breast cancer patients

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Incomplete medical history.
  2. Pregnancy or breast-breeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: 6 weeks
progression-free survival
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR
Time Frame: 6 weeks
Overall Response Rate
6 weeks
CBR
Time Frame: 6 weeks
Clinical benefit Rates
6 weeks
OS
Time Frame: 6 weeks
Overall Survival
6 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: 6 weeks
Safety
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2021

Primary Completion (Anticipated)

July 1, 2024

Study Completion (Anticipated)

July 1, 2024

Study Registration Dates

First Submitted

October 8, 2022

First Submitted That Met QC Criteria

October 25, 2022

First Posted (Actual)

October 26, 2022

Study Record Updates

Last Update Posted (Actual)

April 4, 2023

Last Update Submitted That Met QC Criteria

March 31, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YOUNGBC-24

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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