HER2-positive Breast CancerTraderrusNCT07281001
A Study to Assess the Efficiency of Trastuzumab Deruxtecan in Russian Breast Cancer Patients
A study testing T-DXd 5.4 mg/kg, IVD, 1 cycle every 21 days. in people with HER2-positive Breast Cancer and Trastuzumab Deruxtecan, run by Blokhin's Russian Cancer Research Center at 1 site in Russia.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- HER2-positive Breast Cancer, Trastuzumab Deruxtecan
- What is being tested?
- T-DXd 5.4 mg/kg, IVD, 1 cycle every 21 days.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteRussia
- Study dates
- Dec 2025to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Incomplete medical history.
- Pregnancy or breast-breeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
Federal State Budgetary Institution "N.N. Blokhin National Medical Research Center of Oncology" оf the Ministry of Health of the Russian Federation
Moscow, 115522
Elena А Artamonova, 4994442424, tatiana.titovadoc@gmail.com
About this study
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
Read the detailed description
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
The aim of this trial is to explore the real-world effectiveness T-Dxd and potential predictors in Russian metastatic breast cancer patients
- Being tested
- T-DXd 5.4 mg/kg, IVD, 1 cycle every 21 days.
- Keywords
- Trastuzumab Deruxtecan, HER2-positive Breast Cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Patients with unresectable or metastatic HER2+ BC who have received one or more cycles T-DXd | Experimental | Not described Receives: Drug: T-DXd 5.4 mg/kg, IVD, 1 cycle every 21 days. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
progression-free survival
Measured: 6 weeks
Secondary outcomes (4)
ORR
Overall Response Rate
Measured: 6 weeks
CBR
Clinical benefit Rates
Measured: 6 weeks
OS
Overall Survival
Measured: 6 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Safety
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study startDec 2025 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Blokhin's Russian Cancer Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elena Artamonova, Principal investigator, The Blokhin National Medical Research Center of Oncology of the Russian Ministry of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07281001
- Sponsor's protocol ID
- 29.11.2025
- Acronym
- Traderrus
- Status last verified
- Nov 2025
- First submitted
- 29 Nov 2025
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess the Efficiency of Trastuzumab Deruxtecan in Russian Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT07281001
- Acronym / sponsor ID
- Traderrus / 29.11.2025
- Keywords
- Trastuzumab Deruxtecan, HER2-positive Breast Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Blokhin's Russian Cancer Research CenterUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 15 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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
The aim of this trial is to explore the real-world effectiveness T-Dxd and potential predictors in Russian metastatic breast cancer patients
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Incomplete medical history.
- Pregnancy or breast-breeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T-DXd 5.4 mg/kg, IVD, 1 cycle every 21 days.T-DXd 5.4 mg/kg, IVD, 1 cycle every 21 days. Intravenous infusion | Drug | Patients with unresectable or metastatic HER2+ BC who have received one or more cycles T-DXd |
Primary outcome
PFS
Time frame: 6 weeks
progression-free survival
4 secondary outcomes
ORR
Time frame: 6 weeks
CBR
Time frame: 6 weeks
OS
Time frame: 6 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for HER2-positive Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Recruiting
Short-Term Reduced Dietary Protein in ER+/HER2- Breast Cancer Patients During Neoadjuvant Chemotherapy
Breast Cancer, Hormone Receptor Positive / HER2-negative Breast Cancer
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
RecruitingObservational study
Patient Relevant Outcomes Improvement Program in High Risk Hormone Receptor Positive (HR+) Breast Cancer
HR+/HER2- Early Breast Cancer
RecruitingPhase 3
Adding an Immunotherapy Drug, MEDI4736 (Durvalumab), to the Usual Chemotherapy Treatment (Paclitaxel, Cyclophosphamide, and Doxorubicin) for Stage II-III Breast Cancer
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elena Artamonova principal investigator
The Blokhin National Medical Research Center of Oncology of the Russian Ministry of Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing T-DXd 5.4 mg/kg, IVD, 1 cycle every 21 days. in people with HER2-positive Breast Cancer and Trastuzumab Deruxtecan, run by Blokhin's Russian Cancer Research Center at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elena Artamonova (+7 (499) 444-24-24, tatiana.titovadoc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.