Trial Title:
A Non-interventional Prospective Study of Early HER2-negative High-risk Breast Cancer and BRCA1/2 Mutations Prevalence in RussiA
NCT ID:
NCT05939128
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Study type:
Observational
Overall status:
Active, not recruiting
Study design:
Time perspective:
Prospective
Summary:
(Neo)adjuvant treatment approaches and outcomes
Criteria for eligibility:
Study pop:
Study population will consist of early breast cancer HER2-negative patients with high
risk of recurrence with available medical history, surgery or biopsy FFPE from primary
tumor. It is estimated that approximately 750 patients will be enrolled in approximately
25 sites
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Research Site
Address:
City:
Arkhangelsk
Country:
Russian Federation
Facility:
Name:
Research Site
Address:
City:
Barnaul
Country:
Russian Federation
Facility:
Name:
Research Site
Address:
City:
Belgorod
Country:
Russian Federation
Facility:
Name:
Research Site
Address:
City:
Chelyabinsk
Country:
Russian Federation
Facility:
Name:
Research Site
Address:
City:
Grozny
Country:
Russian Federation
Facility:
Name:
Research Site
Address:
City:
Irkutsk
Country:
Russian Federation
Facility:
Name:
Research Site
Address:
City:
Khanty-Mansiysk
Country:
Russian Federation
Facility:
Name:
Research Site
Address:
City:
Krasnodar
Country:
Russian Federation
Facility:
Name:
Research Site
Address:
City:
Krasnoyarsk
Country:
Russian Federation
Facility:
Name:
Research Site
Address:
City:
Moscow
Country:
Russian Federation
Facility:
Name:
Research Site
Address:
City:
Nalchik
Country:
Russian Federation
Facility:
Name:
Research Site
Address:
City:
Nyzhny Novgorod
Country:
Russian Federation
Facility:
Name:
Research Site
Address:
City:
Ryazan
Country:
Russian Federation
Facility:
Name:
Research Site
Address:
City:
Saint Petersburg
Country:
Russian Federation
Facility:
Name:
Research Site
Address:
City:
Severodvinsk
Country:
Russian Federation
Facility:
Name:
Research Site
Address:
City:
Sochi
Country:
Russian Federation
Facility:
Name:
Research Site
Address:
City:
Ufa
Country:
Russian Federation
Facility:
Name:
Research Site
Address:
City:
Vladivostok
Country:
Russian Federation
Facility:
Name:
Research Site
Address:
City:
Yaroslavl
Country:
Russian Federation
Start date:
June 30, 2023
Completion date:
September 30, 2027
Lead sponsor:
Agency:
AstraZeneca
Agency class:
Industry
Source:
AstraZeneca
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05939128
