Neoadjuvant Chemotherapy in Breast Cancer

NCT ID: NCT04802941

Last Updated: 2021-03-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-12
• Study Completion Date: 2024-03-30

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.

Conditions

Decision Support Systems, Clinical

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Neoadjuvant Chemotherapy by CDSS

Group Type: EXPERIMENTAL

Neoadjuvant Chemotherapy by CDSS (MedicBK)

Intervention Type: DEVICE

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.

Neoadjuvant Chemotherapy in General practice

Group Type: ACTIVE_COMPARATOR

General practice

Intervention Type: DRUG

General practice

Interventions

Neoadjuvant 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.

Intervention Type: DEVICE

General practice

General practice

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Center for New Medical Technologies, Novosibirsk, Russia

OTHER

Sponsor Role: collaborator

I.M. Sechenov First Moscow State Medical University

OTHER

Sponsor Role: collaborator

Novosibirsk Oncology Center

UNKNOWN

Sponsor Role: collaborator

Center of Personalized Medicine, Pirogova

OTHER

Sponsor Role: lead

Responsible Party

Evgeny Pokushalov

Director for research and development

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Evgeny Pokushalov

Novosibirsk, , Russia

Site Status: RECRUITING

Countries

Russia

Central Contacts

Evgeny Pokushalov, Prof. MD PhD

Role: CONTACT

e.pokushalov@gmail.com

89139254858

Irina Ostanina, MD

Role: CONTACT

+79039031563

Facility Contacts

Evgeny Pokushalov, Prof. MD PhD

Role: primary

e.pokushalov@gmail.com

89139254858

Other Identifiers

20210312/2

Identifier Type: -

Identifier Source: org_study_id