Neoadjuvant Chemotherapy in Breast Cancer

Optimizing Neoadjuvant Systemic Treatment for Breast Cancer by Clinical Decision Support System

This study compares two approaches of upfront chemotherapy in breast cancer.

Study Overview

• Status: Recruiting
• Conditions: Decision Support Systems, Clinical
• Intervention / Treatment: Device: Neoadjuvant Chemotherapy by CDSS (MedicBK); Drug: General practice

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.

• Study Type: Interventional
• Enrollment (Anticipated): 1200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Irina Ostanina, MD; Phone Number: +79039031563

Study Locations

• Russian Federation
  • Novosibirsk, Russian Federation, 630090
    • Recruiting
    • Evgeny Pokushalov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Neoadjuvant Chemotherapy by CDSS	Device: 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.
Active Comparator: Neoadjuvant Chemotherapy in General practice	Drug: General practice; General practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with pathological complete response	To compare the efficacy of Neoadjuvant Chemotherapy in general practice and by CDSS	at week 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	up to week 35
identify prognostic and predictive for pathological complete response	To identify prognostic and predictive for pathological complete response after neoadjuvant treatment	within one year after end of treatment

Collaborators and Investigators

• Sponsor: Center of Personalized Medicine, Pirogova
• Collaborators: I.M. Sechenov First Moscow State Medical University; Center for New Medical Technologies, Novosibirsk, Russia; Novosibirsk Oncology Center

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2021
• Primary Completion (Anticipated): March 30, 2024
• Study Completion (Anticipated): March 30, 2024

Study Registration Dates

• First Submitted: March 12, 2021
• First Submitted That Met QC Criteria: March 15, 2021
• First Posted (Actual): March 17, 2021

Study Record Updates

• Last Update Posted (Actual): March 18, 2021
• Last Update Submitted That Met QC Criteria: March 16, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 20210312/2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No