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A Non-interventional Prospective Study of Early HER2-negative High-risk Breast Cancer and BRCA1/2 Mutations Prevalence in RussiA
A Non-interventional Prospective Study of Early HER2-negative High-risk Breast Cancer and BRCA1/2 Mutations Prevalence in RussiA
Active Not RecruitingN/A
Sponsor: AstraZeneca
Conditions: Breast Cancer
Countries: Russia
(Neo)adjuvant treatment approaches and outcomes
Eligibility overview
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: OBSERVATIONAL
Eligibility criteria
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
Locations (19)
- Arkhangelsk, Russia
- Barnaul, Russia
- Belgorod, Russia
- Chelyabinsk, Russia
- Grozny, Russia
- Irkutsk, Russia
- Khanty-Mansiysk, Russia
- Krasnodar, Russia
- Krasnoyarsk, Russia
- Moscow, Russia
- Nal'chik, Russia
- Nyzhny Novgorod, Russia
- Ryazan, Russia
- Saint Petersburg, Russia
- Severodvinsk, Russia
- Sochi, Russia
- Ufa, Russia
- Vladivostok, Russia
- Yaroslavl, Russia