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

Active, not recruiting

• Conditions: Breast Cancer

• Registration Number: NCT05594082
• Lead Sponsor: Fudan University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-01
• Study First Submitted: 2022-10-08
• Study First Submitted QC: 2022-10-25
• Study First Posted: 2022-10-26
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-31
• Last Update Posted: 2023-04-04
• Primary Completion: 2024-07-01
• Study Completion: 2024-07-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 150

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PFS	6 weeks	progression-free survival

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China