Personalized Evidence-based Treatment in Patients With Invasive Breast Cancer

• Conditions: Breast Cancer-specific Survival
• Interventions: Drug: neoadjuvant/adjuvant therapy

• Registration Number: NCT04798976
• Lead Sponsor: Center of Personalized Medicine, Pirogova

Brief Summary

A population-based case-cohort study of breast cancer-specific survival among all first invasive breast cancer cases

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-03
• Study Start: 2021-03-01
• Study First Submitted: 2021-03-11
• Study First Submitted QC: 2021-03-11
• Last Update Submitted: 2021-03-11
• Study First Posted: 2021-03-16
• Last Update Posted: 2021-03-16
• Primary Completion: 2021-05-01
• Study Completion: 2021-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 3000

Inclusion Criteria

All women with stage I-III disease who survived at least 12 months post-diagnosis

Exclusion Criteria

Unknown cause of death Treatment outside the region (thus precluding the treatment assessment)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CDSS (MedicBK) Analysis	neoadjuvant/adjuvant therapy	-
Core Laboratory Analysis	neoadjuvant/adjuvant therapy	-

Primary Outcome Measures

Name	Time	Method
The percentage of guideline-consistent and personalized EBM recommendations	3-year	The percentage of guideline-consistent and personalized EBM recommendations acted on by clinicians in patients with first invasive breast cancer. All discrepancies between routine and CDSS-recommended treatment resulting in frame of guideline-consistent therapy and personalized EBM therapy will be adjudicated by core laboratory.

Secondary Outcome Measures

Name	Time	Method
Breast cancer-specific survival	3-year	All deaths due to breast cancer-related causes
Quantify the performance of the CDSS (MedicBK) algorithm	3-year	Quantify the performance of the CDSS (MedicBK) algorithm for presents treatment suggestions in frame of guideline-based therapy and personalized EBM therapy: the sensitivity, specificity, NPV, and PPV
Predictors	3-year	Predictors of guideline-consistent and personalized EBM adherence

Trial Locations

Locations (1)

Evgeny Pokushalov; 🇷🇺 Novosibirsk, Russian Federation