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NCT05594082 Clinical Trial

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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05594082
Other study ID # YOUNGBC-24
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date November 1, 2021
Est. completion date July 1, 2024

Study information
Verified date March 2023
Source Fudan University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 150
Est. completion date July 1, 2024
Est. primary completion date July 1, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Trastuzumab Deruxtecan
Trastuzumab Deruxtecan, 5.4 mg/kg ivgtt q3w

Locations
Country Name City State
China Fudan University Shanghai Cancer Center Shanghai Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary PFS progression-free survival 6 weeks
Secondary ORR Overall Response Rate 6 weeks
Secondary CBR Clinical benefit Rates 6 weeks
Secondary OS Overall Survival 6 weeks
Secondary Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 Safety 6 weeks
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