This study compares two approaches of upfront chemotherapy in breast cancer.
A Decision Support System (DSS) is an information system that supports business, medical, educational or organisational decision-making activities. DSSs fuse human knowledge and technology to support and improve decision-making. The area of precision oncology that supports the treatment of breast cancer has not only seen an increase in the availability of different treatment choices but also genomic tools to support the decision-making process. CDSSs have been available for use in clinical oncology practice for over a decade. However, there has been some criticism around the utility of CDSS in personalised medicine decision-making of breast cancer, with these systems often viewed as aids better suited to support the 'average' patient's requirements rather than personalised treatment for the individual patient. The purpose of the current study is to evaluate an innovative CDSS (MedicBK) platform based on the comparison of multiple treatments simultaneously in making care decisions taking into account the individual characteristics of patients, i.e., based on personalized evidence-based medicine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,200
CDSS (MedicBK) captures the patient-specific data required to determine appropriate care decisions from the EMR and then presents relevant data alongside treatment suggestions to clinicians. MedicBK uses algorithms for presenting treatment suggestions framed by guideline-based therapy and personalized personalized evidence-based therapy. MedicBK consists of three main blocks: database, network meta-analysis, and heterogeneity of treatment effects assessment.
General practice
Evgeny Pokushalov
Novosibirsk, Russia
RECRUITINGNumber of patients with pathological complete response
To compare the efficacy of Neoadjuvant Chemotherapy in general practice and by CDSS
Time frame: at week 30
Number of patients with grade >2 adverse events as a measure of safety and tolerability
to describe the safety of the various regimens toxicity is compared between the two arms
Time frame: up to week 35
identify prognostic and predictive for pathological complete response
To identify prognostic and predictive for pathological complete response after neoadjuvant treatment
Time frame: within one year after end of treatment
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