Neoadjuvant Chemotherapy in Breast Cancer

NCT04802941 | Unknown

• 1 other identifier: 20210312/2
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Decision Support Systems, Clinical

Outcome Measures

Primary Outcomes (1)

• Number of patients with pathological complete response

  To compare the efficacy of Neoadjuvant Chemotherapy in general practice and by CDSS

  at week 30

Secondary Outcomes (2)

• Number of patients with grade >2 adverse events as a measure of safety and tolerability

  up to week 35

• identify prognostic and predictive for pathological complete response

  within one year after end of treatment

Study Arms (2)

Neoadjuvant Chemotherapy by CDSS

EXPERIMENTAL

Device: Neoadjuvant Chemotherapy by CDSS (MedicBK)

Neoadjuvant Chemotherapy in General practice

ACTIVE COMPARATOR

Drug: General practice

Interventions

Neoadjuvant Chemotherapy by CDSS (MedicBK) 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 by CDSS

General practice DRUG

General practice

Neoadjuvant Chemotherapy in General practice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Evgeny Pokushalov

Novosibirsk, 630090, Russia

RECRUITING

MeSH Terms

Interventions

General Practitioners

Intervention Hierarchy (Ancestors)

Physicians; Health Personnel; Health Care Facilities Workforce and Services

Central Study Contacts

Evgeny Pokushalov, Prof. MD PhD

CONTACT

89139254858; e.pokushalov@gmail.com

Irina Ostanina, MD

CONTACT

+79039031563

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director for research and development

Study Record Dates

• First Submitted: March 12, 2021
• First Posted: March 17, 2021
• Study Start: March 12, 2021
• Primary Completion: March 30, 2024
• Study Completion: March 30, 2024
• Last Updated: March 18, 2021

Record last verified: 2021-03

Locations

RU (1)