Health TrialsbyHealthPanel

A Study to Assess the Efficiency of Trastuzumab Deruxtecan in Russian Breast Cancer Patients

ConditionsHER2-positive Breast CancerTrastuzumab Deruxtecan
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorBlokhin's Russian Cancer Research Center

About this trial

This multi-center observational retrospective study will collect real-world clinical data from eligible patients with unresectable or metastatic HER2+ breast cancer who have received one or more cycles Trastuzumab Deruxtecan in Russian Federation

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Patients has received Trastuzumab Deruxtecan

Available medical history.

Disqualifiers

Incomplete medical history.

Pregnancy or breast-breeding

Trial design

Design model

Single group

Treatments tested in this trial

  • T-DXd 5.4 mg/kg, IVD, 1 cycle every 21 days.

    Drug

    T-DXd 5.4 mg/kg, IVD, 1 cycle every 21 days. Intravenous infusion

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Patients with unresectable or metastatic HER2+ BC who have received one or more cycles T-DXdExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

PFS

progression-free survival

Time frame
6 weeks

Secondary outcomes

1

ORR

Overall Response Rate

Time frame
6 weeks
2

CBR

Clinical benefit Rates

Time frame
6 weeks
3

OS

Overall Survival

Time frame
6 weeks
4

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

Safety

Time frame
6 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Blokhin's Russian Cancer Research Center

Lead sponsor

Source ClinicalTrials.gov
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