Status:
UNKNOWN
Neoadjuvant Chemotherapy in Breast Cancer
Lead Sponsor:
Center of Personalized Medicine, Pirogova
Collaborating Sponsors:
Center for New Medical Technologies, Novosibirsk, Russia
I.M. Sechenov First Moscow State Medical University
Conditions:
Decision Support Systems, Clinical
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2024
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT04802941
Start Date
March 12 2021
End Date
March 30 2024
Last Update
March 18 2021
Active Locations (1)
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1
Evgeny Pokushalov
Novosibirsk, Russia, 630090