NCT07281001

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 15, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

December 15, 2025

Status Verified

November 1, 2025

Enrollment Period

5 months

First QC Date

November 29, 2025

Last Update Submit

December 11, 2025

Conditions

HER2-positive Breast CancerTrastuzumab Deruxtecan

Keywords

Trastuzumab DeruxtecanHER2-positive Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • PFS

    progression-free survival

    6 weeks

Secondary Outcomes (4)

  • ORR

    6 weeks

  • CBR

    6 weeks

  • OS

    6 weeks

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

    6 weeks

Study Arms (1)

Patients with unresectable or metastatic HER2+ BC who have received one or more cycles T-DXd

EXPERIMENTAL
Drug: T-DXd 5.4 mg/kg, IVD, 1 cycle every 21 days.

Interventions

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

Patients with unresectable or metastatic HER2+ BC who have received one or more cycles T-DXd

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Incomplete medical history.
  • Pregnancy or breast-breeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal State Budgetary Institution "N.N. Blokhin National Medical Research Center of Oncology" оf the Ministry of Health of the Russian Federation

Moscow, 115522, Russia

RECRUITING

MeSH Terms

Interventions

Isovaleryl-CoA Dehydrogenase

Intervention Hierarchy (Ancestors)

Oxidoreductases Acting on CH-CH Group DonorsOxidoreductasesEnzymesEnzymes and Coenzymes

Study Officials

  • Elena Artamonova

    The Blokhin National Medical Research Center of Oncology of the Russian Ministry of Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elena Artamonova

CONTACT

+7 (499) 444-24-24tatiana.titovadoc@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2025

First Posted

December 15, 2025

Study Start

December 1, 2025

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

December 15, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)