Neoadjuvant Chemotherapy in Breast Cancer

Center of Personalized Medicine, Pirogova

Status

Unknown

Conditions

Decision Support Systems, Clinical

Treatments

Drug: General practice

Device: Neoadjuvant Chemotherapy by CDSS (MedicBK)

Study type

Interventional

Funder types

Other

Identifiers

NCT04802941

20210312/2

Details and patient eligibility

About

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

Full 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.

Enrollment

1,200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.