Neoadjuvant Chemotherapy in Breast Cancer

Study Overview
=================
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.

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

Conditions
-----------------
Decision Support Systems, Clinical

Intervention / Treatment
-----------------
* Device: Neoadjuvant Chemotherapy by CDSS (MedicBK)
* Drug: General practice


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neoadjuvant Chemotherapy by CDSS<br> | Device: Neoadjuvant Chemotherapy by CDSS (MedicBK)<br>* 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.<br>|
| Active Comparator: Neoadjuvant Chemotherapy in General practice<br> | Drug: General practice<br>* General practice<br>|

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 |