Clinical Study of Personalized Chemotherapy for Breast Cancer With Low Doses of Cyclophosphamide

Launched by KARANAHAN · Apr 8, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new approach to treating advanced breast cancer (stage IV) using personalized chemotherapy with low doses of a medication called cyclophosphamide. The main goal is to see if this tailored treatment can effectively reduce the size of tumors and improve the condition of the cancerous areas in the body. To do this, doctors will first collect a small sample of the tumor during surgery and analyze it to understand the tumor cells' repair cycle. Based on this analysis, participants will receive a specific treatment plan that includes four intravenous injections of cyclophosphamide and additional targeted therapies, spaced out over several weeks.

To be eligible for the study, participants should be women aged 65 to 74 with advanced breast cancer that has progressed, and their tumors must be accessible for testing. They also need to understand the nature of their illness and the treatment being offered. However, individuals with serious health issues, allergic reactions to cyclophosphamide, or those currently participating in another clinical trial cannot join. Participants can expect close monitoring and a structured treatment schedule, which may provide a new option for managing their condition.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • stage IV breast cancer or progression of the disease with the presence of foci accessible for biopsy of tumor material;
• • complete awareness of the patient about the prognosis of the disease and the proposed treatment;
• • the volume of tumor material required for vital assessment of the time parameters of the individual reparative cycle of tumor cells must be at least 4 cm3;
• • tumor cells transferred to primary culture must be in a state of proliferative activity.
• Exclusion Criteria:
• • severe decompensated cardiovascular, respiratory, hepatic, renal failure;
• • presence of an acute infectious disease;
• • intolerance to cyclophosphamide;
• • severe neutropenia - the content of neutrophils is less than 1000 per 1 μl of blood;
• • simultaneous participation in another clinical trial.