A Non-interventional Prospective Study of Early HER2-negative High-risk Breast Cancer and BRCA1/2 Mutations Prevalence in RussiA

Breast Cancer Clinical Trial

— ERA  

Official title:

A Multicentre, Single Arm, Non-interventional, Observational, Prospective Study to Assess the BRCA1/2m Prevalence, Treatment Approaches and Outcomes in HER2-negative High-risk Early Breast Cancer Patients in Russia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05939128
• Other study ID #: D133HR00030
• Status: Recruiting
• Start date: June 30, 2023
• Est. completion date: June 30, 2027

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

(Neo)adjuvant treatment approaches and outcomes

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 750
• Est. completion date: June 30, 2027
• Est. primary completion date: June 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients aged = 18 years old

-. Signed ICF, including patient's consent for genetic testing specimens from primary tumor and blood samples

• Early HER2-negative BC (stages 2 and 3)

• Compliance with at least 1 of the criteria for BRCA1/2 testing in accordance with the clinical guidelines of the Ministry of Health of the Russian Federation

• Unknown BRCAm status or negative BRCAm PCR test

• Performed surgical treatment (not more than 7 months before inclusion)

-. High risk of recurrence according to one or more criteria:

1. incomplete pathomorphological response (in case of neoadjuvant therapy)

2. CPS-EG 3 scale score 3 and more (in case of neoadjuvant therapy)

3. presence of = 4 metastatic lymph nodes in HR+ pts (in case of only adjuvant therapy)

4. =pT2 or =pN1 in TNBC pts (in case of only adjuvant therapy)

5. Any other high risk criterion according to investigators opinion

• The presence of postoperative or biopsy FFPE

Exclusion Criteria:

• Participation in another clinical study with an investigational product during the last 3 months

• Confirmation that the subject was already included in this study before

• Absence of a written informed consent form; Data erroneously collected from subjects for which written consent is not available, will not be included in or will be deleted from the study database

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
Russian Federation	Research Site	Arkhangelsk
Russian Federation	Research Site	Barnaul
Russian Federation	Research Site	Belgorod
Russian Federation	Research Site	Chelyabinsk
Russian Federation	Research Site	Ekaterinburg
Russian Federation	Research Site	Grozny
Russian Federation	Research Site	Irkutsk
Russian Federation	Research Site	Kazan
Russian Federation	Research Site	Khanty-Mansiysk
Russian Federation	Research Site	Krasnodar
Russian Federation	Research Site	Krasnoyarsk
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Nalchik
Russian Federation	Research Site	Nyzhny Novgorod
Russian Federation	Research Site	Ryazan
Russian Federation	Research Site	Saint Petersburg
Russian Federation	Research Site	Samara
Russian Federation	Research Site	Severodvinsk
Russian Federation	Research Site	Sochi
Russian Federation	Research Site	Tomsk
Russian Federation	Research Site	Ufa
Russian Federation	Research Site	Vladivostok
Russian Federation	Research Site	Yaroslavl

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary objective of this study is to determine the prevalence of germline and somatic BRCA1/2 mutations in high-risk early HER2-negative breast cancer	The prevalence of germline and somatic BRCA1/2 mutations in high-risk early HER2-negative breast cancer will be presented as a number of missing and non-missing records, median, standard deviation, 95% confidence interval for median	3 years
Secondary	To describe treatment approaches of high-risk early HER2-negative breast cancer in routine practice in the general population, in the BRCAm and non-BRCAm population	Demographics, clinical characteristics, and treatment approaches will be summarized using descriptive statistics.	3 years
Secondary	To determine invasive disease-free survival for high-risk early HER2-negative breast cancer in the general population, in the BRCAm and non-BRCAm population	The Kaplan-Meier method will be used to estimate the median (95% CI) IDFS and OS for the total sample and all subgroups. Cumulative survival curves will be created using Kaplan-Meier analysis	3 years
Secondary	To determine 3-year OS for high-risk early HER2-negative breast cancer in the general population, in the BRCAm and non-BRCAm population	The Kaplan-Meier method will be used to estimate the median (95% CI) IDFS and OS for the total sample and all subgroups. Cumulative survival curves will be created using Kaplan-Meier analysis	3 years
Secondary	To determine the prevalence of HRR mutations in HER2-negative breast cancer	Testing the archived tumour specimen and blood for BRCA1/2m and HRRm status	3 years
Secondary	To determine invasive disease-free survival in the HRRm population (including BRCA1/2)	Testing the archived tumour specimen and blood for BRCA1/2m and HRRm status	3 years
Secondary	To evaluate concordance between P53 expression and BRCAm	Testing the archived tumour specimen and blood	3 years
Secondary	To assess the quality of life in patients with various types of adjuvant systemic therapy	completed WHOQOL-BREF questionnaire will be assessed	3 years