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

EARLY_PHASE1RecruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

November 1, 2018

Primary Completion Date

December 1, 2024

Study Completion Date

December 1, 2025

Conditions
Stage IV Breast Cancer
Interventions
COMBINATION_PRODUCT

Karanahan

During the preparatory stage, a tumor sample from participant is harvested intraoperatively. The primary culture is obtained from this tumor tissue sample. Repair cycle time is estimated, and the day when tumor cells are synchronized at the cell cycle G2/M phase is identified. The schedule of administering cyclophosphamide and DNAmix complex composite preparation is calculated according to the resulting time points. According to the elaborated regimen, the participant receives 4 intravenous cyclophosphamide injections at the dose of 300 mg/m2 in combination with 4 injections of 1-12 mg of DNAmix administered into prominent tumor nidi and lymph depots. The participant receives from 2 to 6 courses of therapy. The interval between courses is 21 days.

Trial Locations (1)

630090

RECRUITING

Karanahan Llc, Novosibirsk

All Listed Sponsors
lead

KARANAHAN

OTHER