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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05594082

Enrollment

150

Registered

2022-10-26

Start date

2021-11-01

Completion date

2024-07-01

Last updated

2023-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Brief summary

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

Interventions

DRUGTrastuzumab Deruxtecan

Trastuzumab Deruxtecan, 5.4 mg/kg ivgtt q3w

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
PFS	6 weeks	progression-free survival

Secondary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026