Trial Title:
HER2-low Unresectable and/or Metastatic Breast Cancer in Russia
NCT ID:
NCT05913440
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
Summary:
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 ).
Criteria for eligibility:
Study pop:
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 ).
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patients with previous HER2 positive status in the anamnesis at the diagnosis or
after the diagnosis of breast cancer.
- Presence of other malignancies within period since diagnosis until the timepoint of
data collection.
- Patients receiving trastuzumab deruxtecan currently or received in anamnesis.
- The participation in any randomised controlled trial within period since diagnosis
until end of study.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Research Site
Address:
City:
Arkhangelsk
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Balashikha
Country:
Russian Federation
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Barnaul
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Belgorod
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Chelyabinsk
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Chita
Country:
Russian Federation
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Grozny
Country:
Russian Federation
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Grozny
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Irkutsk
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Istra
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Izhevsk
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Kaluga
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Kazan
Country:
Russian Federation
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Kemerovo
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Khanty-Mansiysk
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Khimki
Country:
Russian Federation
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Kirov
Country:
Russian Federation
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Kirov
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Klin
Country:
Russian Federation
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Kolomna
Country:
Russian Federation
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Korolev
Country:
Russian Federation
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Kostroma
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Krasnodar
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Krasnoyarsk
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Makhachkala
Country:
Russian Federation
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Maykop
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Moscow
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Moscow
Country:
Russian Federation
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Nalchik
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Nizhny Novgorod
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Novokuznetsk
Country:
Russian Federation
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Novokuznetsk
Country:
Russian Federation
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Novosibirsk
Country:
Russian Federation
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Novosibirsk
Country:
Russian Federation
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Noyabrsk
Country:
Russian Federation
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Omsk
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Orenburg
Country:
Russian Federation
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Orenburg
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Perm
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Plievo
Country:
Russian Federation
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Podolsk
Country:
Russian Federation
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Pyatigorsk
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Rostov-on-Don
Country:
Russian Federation
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Ryazan
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Saint Petersburg
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Saint Petersburg
Country:
Russian Federation
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Saint Petersburg
Country:
Russian Federation
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Samara
Country:
Russian Federation
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Saransk
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Saratov
Country:
Russian Federation
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Severodvinsk
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Sochi
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Surgut
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Syktyvkar
Country:
Russian Federation
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Tomsk
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Tver
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Ufa
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Ulan-Ude
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Ulyanovsk
Country:
Russian Federation
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Vladivostok
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Vladivostok
Country:
Russian Federation
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Volgograd
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Voronezh
Country:
Russian Federation
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Yaroslavl
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Yekaterinburg
Country:
Russian Federation
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Yuzhno-Sakhalinsk
Country:
Russian Federation
Status:
Recruiting
Start date:
May 30, 2023
Completion date:
December 31, 2024
Lead sponsor:
Agency:
AstraZeneca
Agency class:
Industry
Source:
AstraZeneca
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05913440
