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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

NCT05939128

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