NCT05913440Completed
HER2-low Unresectable and/or Metastatic Breast Cancer in Russia
A Multicenter Observational Retrospective Study of Therapeutic Approaches and Clinical Outcomes in Real Clinical Practice in Russian Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Low Unresectable and/or Metastatic Breast Cancer
Source: ClinicalTrials.gov · Last updated 12 Mar 2026
Brief summary (registry, in English)
Planned study population consists of approximately 3,150 adult patients with HER2-negative (IHC 0, + or IHC2+/ISH-) unresectable or metastatic BC enrolled to the study in order to obtain approximately 2,000 patients with confirmed HER2 low status (IHC1+ or IHC2+/ISH ).
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 1669 (actual)
- First submitted
- 30 May 2023
- Start date
- 30 May 2023
- Primary completion date
- 14 Mar 2025
- Lead sponsor
- AstraZeneca
- Diseases
- Metastatic breast cancer
- NCT number
- NCT05913440
What you commit to
- Study type: Observational
- Participants enrolled: 1669
- From 30 May 2023 to the primary completion date, 14 Mar 2025
- 40 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with previous HER2 positive status in the anamnesis at the diagnosis or after the diagnosis of breast cancer.
- Patients receiving trastuzumab deruxtecan currently or received in anamnesis.
Other illness
- Presence of other malignancies within period since diagnosis until the timepoint of data collection.
Other
- The participation in any randomised controlled trial within period since diagnosis until end of study.
Who the study is looking for
- Patients with confirmed diagnosis of unresectable and/or metastatic BC established between the 1st July 2021 and the 1st July 2022.
- Patients have HER2-negative status (IHC0, IHC1+, IHC2+/ISH-) obtained in the local laboratory.
- -. Patients have an adequate archival tumor sample and slides suitable for reassessment HER2 status\* by the reference laboratory.
- Patients have documented hormonal status (ER, PR) IHC score.
- Age ≥ 18 years at the time of inclusion.
- Patients provided written consent allowing for data and samples to be used in the future and this study would be covered by the consent for future use in accordance with ICH GCP, GPP (Good Pharmacoepidemiology Practices) and local law prior to inclusion in the study. If the patient is deceased, a waiver may be accepted
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (40)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.