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

• Sponsor: AstraZeneca (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05913440
• Collaborator: (none)
• Enrollment: 3,150
• Locations: 42
• Anticipated Duration (Months): 13
• Patients Per Site: 75
• Patients Per Site Per Month: 5.8

Study Details

Study Description

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 ).

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer

Study Design

• Study Type: Observational
• Anticipated Enrollment: 3150 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• 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
• Actual Study Start Date: May 30, 2023
• Anticipated Primary Completion Date: Jun 30, 2024
• Anticipated Study Completion Date: Jun 30, 2024

Outcome Measures

Primary Outcome Measures

1. 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]

2. 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 [12 months]

   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).

Secondary Outcome Measures

1. 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 [12 months]

   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

2. 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). [12 months]

   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

3. 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 [12 months]

   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

4. 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 [12 months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Arkhangelsk		Russian Federation
2	Research Site	Balashikha		Russian Federation
3	Research Site	Barnaul		Russian Federation
4	Research Site	Belgorod		Russian Federation
5	Research Site	Cheliabinsk		Russian Federation
6	Research Site	Ekaterinburg		Russian Federation
7	Research Site	Grozny		Russian Federation
8	Research Site	Istra		Russian Federation
9	Research Site	Kaluga		Russian Federation
10	Research Site	Kazan		Russian Federation
11	Research Site	Kemerovo		Russian Federation
12	Research Site	Khabarovsk		Russian Federation
13	Research Site	Khanty-Mansiysk		Russian Federation
14	Research Site	Kirov		Russian Federation
15	Research Site	Kostroma		Russian Federation
16	Research Site	Krasnodar		Russian Federation
17	Research Site	Krasnoyarsk		Russian Federation
18	Research Site	Maikop		Russian Federation
19	Research Site	Moscow		Russian Federation
20	Research Site	Nalchik		Russian Federation
21	Research Site	Nizhny Novgorod		Russian Federation
22	Research Site	Novokuznetsk		Russian Federation
23	Research Site	Novosibirsk		Russian Federation
24	Research Site	Orenburg		Russian Federation
25	Research Site	Perm		Russian Federation
26	Research Site	Rostov-on-Don		Russian Federation
27	Research Site	Ryazan		Russian Federation
28	Research Site	Saint-Peterburg		Russian Federation
29	Research Site	Samara		Russian Federation
30	Research Site	Saratov		Russian Federation
31	Research Site	Surgut		Russian Federation
32	Research Site	Syktyvkar		Russian Federation
33	Research Site	Tomsk		Russian Federation
34	Research Site	Tver		Russian Federation
35	Research Site	Ufa		Russian Federation
36	Research Site	Ulan-Ude		Russian Federation
37	Research Site	Ulianovsk		Russian Federation
38	Research Site	Vladivostok		Russian Federation
39	Research Site	Volgograd		Russian Federation
40	Research Site	Voronezh		Russian Federation
41	Research Site	Yaroslavl		Russian Federation
42	Research Site	Yuzhno-sakhalinsk		Russian Federation

Sponsors and Collaborators

• AstraZeneca

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AstraZeneca
• ClinicalTrials.gov Identifier: NCT05913440
• Other Study ID Numbers: D133HR00029
• First Posted: Jun 22, 2023
• Last Update Posted: Jun 29, 2023
• Last Verified: Jun 1, 2023

• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Jun 29, 2023