Clinical trial NCT05913440: HER2-low Unresectable and/or Metastatic Breast Cancer in Russia
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2023-06-22
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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 ).

Brief 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 ).


Eligibility 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.

Primary outcomes:
measure: 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
timeFrame: 12 months
measure: 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
timeFrame: 12 months
Secondary outcomes:
measure: 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
timeFrame: 12 months
measure: 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).
timeFrame: 12 months
measure: 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
timeFrame: 12 months
measure: 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
timeFrame: 12 months
measure: To describe the concordance of HER2 status evaluations performed in a reference laboratory by a pathologist manually and by an artificial intelligence (AI) program.
timeFrame: 12 months
Other outcomes:
Locations:
city: Arkhangelsk
country: Russian Federation
facility: Research Site
city: Balashikha
country: Russian Federation
facility: Research Site
city: Barnaul
country: Russian Federation
facility: Research Site
city: Belgorod
country: Russian Federation
facility: Research Site
city: Chelyabinsk
country: Russian Federation
facility: Research Site
city: Chita
country: Russian Federation
facility: Research Site
city: Grozny
country: Russian Federation
facility: Research Site
city: Grozny
country: Russian Federation
facility: Research Site
city: Irkutsk
country: Russian Federation
facility: Research Site
city: Istra
country: Russian Federation
facility: Research Site
city: Izhevsk
country: Russian Federation
facility: Research Site
city: Kaluga
country: Russian Federation
facility: Research Site
city: Kazan
country: Russian Federation
facility: Research Site
city: Kemerovo
country: Russian Federation
facility: Research Site
city: Khanty-Mansiysk
country: Russian Federation
facility: Research Site
city: Khimki
country: Russian Federation
facility: Research Site
city: Kirov
country: Russian Federation
facility: Research Site
city: Kirov
country: Russian Federation
facility: Research Site
city: Klin
country: Russian Federation
facility: Research Site
city: Kolomna
country: Russian Federation
facility: Research Site
city: Korolev
country: Russian Federation
facility: Research Site
city: Kostroma
country: Russian Federation
facility: Research Site
city: Krasnodar
country: Russian Federation
facility: Research Site
city: Krasnoyarsk
country: Russian Federation
facility: Research Site
city: Makhachkala
country: Russian Federation
facility: Research Site
city: Maykop
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Nalchik
country: Russian Federation
facility: Research Site
city: Nizhny Novgorod
country: Russian Federation
facility: Research Site
city: Novokuznetsk
country: Russian Federation
facility: Research Site
city: Novokuznetsk
country: Russian Federation
facility: Research Site
city: Novosibirsk
country: Russian Federation
facility: Research Site
city: Novosibirsk
country: Russian Federation
facility: Research Site
city: Noyabrsk
country: Russian Federation
facility: Research Site
city: Omsk
country: Russian Federation
facility: Research Site
city: Orenburg
country: Russian Federation
facility: Research Site
city: Orenburg
country: Russian Federation
facility: Research Site
city: Perm
country: Russian Federation
facility: Research Site
city: Plievo
country: Russian Federation
facility: Research Site
city: Podolsk
country: Russian Federation
facility: Research Site
city: Pyatigorsk
country: Russian Federation
facility: Research Site
city: Rostov-on-Don
country: Russian Federation
facility: Research Site
city: Ryazan
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Samara
country: Russian Federation
facility: Research Site
city: Saransk
country: Russian Federation
facility: Research Site
city: Saratov
country: Russian Federation
facility: Research Site
city: Sevedorvinsk
country: Russian Federation
facility: Research Site
city: Smolensk
country: Russian Federation
facility: Research Site
city: Sochi
country: Russian Federation
facility: Research Site
city: Surgut
country: Russian Federation
facility: Research Site
city: Syktyvkar
country: Russian Federation
facility: Research Site
city: Tomsk
country: Russian Federation
facility: Research Site
city: Tver
country: Russian Federation
facility: Research Site
city: Tver
country: Russian Federation
facility: Research Site
city: Ufa
country: Russian Federation
facility: Research Site
city: Ulan-Ude
country: Russian Federation
facility: Research Site
city: Ulyanovsk
country: Russian Federation
facility: Research Site
city: Vladivostok
country: Russian Federation
facility: Research Site
city: Vladivostok
country: Russian Federation
facility: Research Site
city: Volgograd
country: Russian Federation
facility: Research Site
city: Voronezh
country: Russian Federation
facility: Research Site
city: Yaroslavl
country: Russian Federation
facility: Research Site
city: Yekaterinburg
country: Russian Federation
facility: Research Site
city: Yuzhno-Sakhalinsk
country: Russian Federation
facility: Research Site
Study officials:
References: