Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
AstraZeneca
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | A Non-interventional Prospective Study of Early HER2-negative High-risk Breast Cancer and BRCA1/2 Mutations Prevalence in RussiA
