Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2025-12-26 @ 10:36 AM
NCT ID:
NCT05939128
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05939128
Study Brief:
Protocol Section:
NCT05939128