Decision Support Systems, Clinical
Conditions
Brief summary
This study compares two approaches of upfront chemotherapy in breast cancer.
Detailed description
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.
Interventions
DEVICENeoadjuvant Chemotherapy by CDSS (MedicBK)
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.
DRUGGeneral practice
General practice
Sponsors
Center for New Medical Technologies, Novosibirsk, Russia
I.M. Sechenov First Moscow State Medical University
Novosibirsk Oncology Center
Center of Personalized Medicine, Pirogova
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed infiltrating breast cancer * Stage II or stage III disease. Nodal status must be examined by ultrasound, fine needle aspiration, sentinel node biopsy, or FDG-PET scan. * Age ≥18 * Eastern Cooperative Oncology Group performance status ≤1 * Adequate bone marrow function (ANC \>1.5 x 109/l, platelets \>100 x 109/l) * Adequate hepatic function (ALAT, ASAT and bilirubin \<2.5 times upper limit of normal) * Adequate renal function (creatinine clearance \>50 ml/min) * LVEF ≥50% measured by echocardiography or MUGA * Absence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule * Absence of any medical condition that would place the patient at unusual risk. * Signed written informed consent
Exclusion criteria
* previous radiation therapy or chemotherapy * other malignancy except carcinoma in situ, unless the other malignancy was treated ≥5 years ago with curative intent without the use of chemotherapy or radiation therapy. * current pregnancy or breastfeeding. Women of childbearing potential must use adequate contraceptive protection * evidence of distant metastases. Evaluation of the presence of distant metastases may include chest X-ray, liver ultrasound, isotope bone-scan, CT-scan of chest and abdomen and/or FDG-PET scan, according to local procedures. * evidence of bilateral infiltrating breast cancer. Evaluation of the presence of bilateral infiltrating breast cancer may include mammography, breast ultrasound and/or MRI breast. * concurrent anti-cancer treatment or another investigational drug.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with pathological complete response | at week 30 | To compare the efficacy of Neoadjuvant Chemotherapy in general practice and by CDSS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with grade >2 adverse events as a measure of safety and tolerability | up to week 35 | to describe the safety of the various regimens toxicity is compared between the two arms |
| identify prognostic and predictive for pathological complete response | within one year after end of treatment | To identify prognostic and predictive for pathological complete response after neoadjuvant treatment |
Countries
Russia
Contacts
Primary ContactEvgeny Pokushalov, Prof. MD PhD
Backup ContactIrina Ostanina, MD
Outcome results
None listed