HER2-low Unresectable and/or Metastatic Breast Cancer in Russia

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05913440
• Other study ID #: D133HR00029
• Status: Recruiting
• Start date: May 30, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2024
• Source: AstraZeneca
• Contact: AstraZeneca Clinical Study Information Center
• Phone: 1-877-240-9479
• Email: information.center[@]astrazeneca.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 ).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2450
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
Russian Federation	Research Site	Arkhangelsk
Russian Federation	Research Site	Balashikha
Russian Federation	Research Site	Barnaul
Russian Federation	Research Site	Belgorod
Russian Federation	Research Site	Chelyabinsk
Russian Federation	Research Site	Chita
Russian Federation	Research Site	Grozny
Russian Federation	Research Site	Grozny
Russian Federation	Research Site	Irkutsk
Russian Federation	Research Site	Istra
Russian Federation	Research Site	Izhevsk
Russian Federation	Research Site	Kaluga
Russian Federation	Research Site	Kazan
Russian Federation	Research Site	Kemerovo
Russian Federation	Research Site	Khanty-Mansiysk
Russian Federation	Research Site	Khimki
Russian Federation	Research Site	Kirov
Russian Federation	Research Site	Klin
Russian Federation	Research Site	Kolomna
Russian Federation	Research Site	Korolev
Russian Federation	Research Site	Kostroma
Russian Federation	Research Site	Krasnodar
Russian Federation	Research Site	Krasnoyarsk
Russian Federation	Research Site	Makhachkala
Russian Federation	Research Site	Maykop
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Nalchik
Russian Federation	Research Site	Nizhny Novgorod
Russian Federation	Research Site	Novokuznetsk
Russian Federation	Research Site	Novokuznetsk
Russian Federation	Research Site	Novosibirsk
Russian Federation	Research Site	Novosibirsk
Russian Federation	Research Site	Noyabrsk
Russian Federation	Research Site	Omsk
Russian Federation	Research Site	Orenburg
Russian Federation	Research Site	Perm
Russian Federation	Research Site	Plievo
Russian Federation	Research Site	Podolsk
Russian Federation	Research Site	Pyatigorsk
Russian Federation	Research Site	Rostov-on-Don
Russian Federation	Research Site	Ryazan
Russian Federation	Research Site	Saint Petersburg
Russian Federation	Research Site	Saint Petersburg
Russian Federation	Research Site	Saint Petersburg
Russian Federation	Research Site	Samara
Russian Federation	Research Site	Saransk
Russian Federation	Research Site	Saratov
Russian Federation	Research Site	Sevedorvinsk
Russian Federation	Research Site	Sochi
Russian Federation	Research Site	Surgut
Russian Federation	Research Site	Syktyvkar
Russian Federation	Research Site	Tomsk
Russian Federation	Research Site	Tver
Russian Federation	Research Site	Ufa
Russian Federation	Research Site	Ulan-Ude
Russian Federation	Research Site	Ulyanovsk
Russian Federation	Research Site	Vladivostok
Russian Federation	Research Site	Volgograd
Russian Federation	Research Site	Voronezh
Russian Federation	Research Site	Yaroslavl
Russian Federation	Research Site	Yekaterinburg
Russian Federation	Research Site	Yekaterinburg
Russian Federation	Research Site	Yuzhno-Sakhalinsk

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To study the overall prevalence of HER2-low among patients with HER2-negative mBC, based on reassessment of historical HER2 fixed tissue IHC stained slides assay in the Russian Federation		12 months
Primary	To study the clinical-pathological, histopathological and demographic profiles of patients of HR-positive and HR-negative HER2-low status among unresectable and/or mBC patients identified as HER2-negative HR-positive/negative	Clinical and demographic data, as well as other study variables will be presented as frequencies or percentages, or as the mean value, standard deviation, median, quantiles, minimum and maximum, depending on the type of variable (continuous or categorical) for the total sample and all subgroups (if applicable).	12 months
Secondary	To describe data on the diagnostic algorithms and therapeutic tactics in patients with HR-positive and HR-negative HER2-low unresectable and/or mBC in routine practice in the Russian Federation	Data on methods used for diagnosis will be presented as frequencies or percentages, or as the mean value, standard deviation, median, quartiles, minimum and maximum, depending on the type of variable (categorical or continuous) for the total sample and all subgroups	12 months
Secondary	To describe data on the treatment approach in patients with HR-positive and HR-negative HER2-low unresectable and/or mBC in routine practice in the Russian Federation, and the sequence of therapy administration (HR-positive and HR-negative).	Data on methods used for anticancer and concomitant treatment will be presented as frequencies or percentages, or as the mean value, standard deviation, median, quartiles, minimum and maximum, depending on the type of variable (categorical or continuous) for the total sample and all subgroups	12 months
Secondary	To assess the treatment outcomes of patients with HR-positive and HR-negative HER2-low unresectable and/or mBC in routine practice in the Russian Federation	Data on methods used for anticancer and concomitant treatment will be presented as frequencies or percentages, or as the mean value, standard deviation, median, quartiles, minimum and maximum, depending on the type of variable (categorical or continuous) for the total sample and all subgroups	12 months
Secondary	To characterize the concordance between HER2 IHC scores in local and reference laboratories after reassessment in the reference lab (IHC 0, 1+, 2+/ISH-) using the existing, and refined, criteria of ASCO/CAP definition	The frequency of concordance of IHC HER2 scores and ISH results between local and reference laboratories will be calculated along with exact 95% CIs. Cohen's Kappa statistics will be used to evaluate concordance between HER2 IHC scores in local and reference laboratories.	12 months