Clinical trial NCT05939128: A Non-interventional Prospective Study of Early HER2-negative High-risk Breast Cancer and BRCA1/2 Mutations Prevalence in RussiA
Official title: A Multicentre, Single Arm, Non-interventional, Observational, Prospective Study to Assess the BRCA1/2m Prevalence, Treatment Approaches and Outcomes in HER2-negative High-risk Early Breast Cancer Patients in Russia
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2023-07-11
Enrollment: 625
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

Brief summary: (Neo)adjuvant treatment approaches and outcomes


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

Primary outcomes:
measure: The primary objective of this study is to determine the prevalence of germline and somatic BRCA1/2 mutations in high-risk early HER2-negative breast cancer
timeFrame: 3 years
Secondary outcomes:
measure: To describe treatment approaches of high-risk early HER2-negative breast cancer in routine practice in the general population, in the BRCAm and non-BRCAm population
timeFrame: 3 years
measure: To determine invasive disease-free survival for high-risk early HER2-negative breast cancer in the general population, in the BRCAm and non-BRCAm population
timeFrame: 3 years
measure: To determine 3-year OS for high-risk early HER2-negative breast cancer in the general population, in the BRCAm and non-BRCAm population
timeFrame: 3 years
measure: To determine the prevalence of HRR mutations in HER2-negative breast cancer
timeFrame: 3 years
measure: To determine invasive disease-free survival in the HRRm population (including BRCA1/2)
timeFrame: 3 years
measure: To evaluate concordance between P53 expression and BRCAm
timeFrame: 3 years
measure: To assess the quality of life in patients with various types of adjuvant systemic therapy
timeFrame: 3 years
Other outcomes:
Locations:
city: Arkhangelsk
country: Russian Federation
facility: Research Site
city: Barnaul
country: Russian Federation
facility: Research Site
city: Belgorod
country: Russian Federation
facility: Research Site
city: Chelyabinsk
country: Russian Federation
facility: Research Site
city: Grozny
country: Russian Federation
facility: Research Site
city: Irkutsk
country: Russian Federation
facility: Research Site
city: Khanty-Mansiysk
country: Russian Federation
facility: Research Site
city: Krasnodar
country: Russian Federation
facility: Research Site
city: Krasnoyarsk
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Nalchik
country: Russian Federation
facility: Research Site
city: Nyzhny Novgorod
country: Russian Federation
facility: Research Site
city: Ryazan
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Severodvinsk
country: Russian Federation
facility: Research Site
city: Sochi
country: Russian Federation
facility: Research Site
city: Ufa
country: Russian Federation
facility: Research Site
city: Vladivostok
country: Russian Federation
facility: Research Site
city: Yaroslavl
country: Russian Federation
facility: Research Site
Study officials:
References: