NCT06361264

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

Recruiting now EARLY_PHASE1 Last updated 11 April 2024

What this trial tests

EARLY_PHASE1 trial testing Karanahan in Stage IV Breast Cancer in 20 participants. Currently enrolling.

Timeline

1 November 2018

Primary endpoint
1 December 2024

1 December 2025

Quick facts

Lead sponsor	KARANAHAN
Phase	EARLY_PHASE1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	1 November 2018
Primary completion	1 December 2024
Estimated completion	1 December 2025
Sites	1 location across Russia

Drugs / interventions tested

• Karanahan

Conditions studied

• Stage IV Breast Cancer — all drugs for Stage IV Breast Cancer →

Sponsor

KARANAHAN

Who can join

18 and older, female only, with Stage IV Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this study is to evaluate the safety and clinical efficacy of personalized chemotherapy with low doses of cyclophosphamide administered taking into account the reparative cycle of tumor cells in participants with breast cancer (stage IV or disease progression). The main question it aims to answer is: Does personalized chemotherapy of breast cancer with low doses of cyclophosphamide, taking into account the reparative cycle of tumor cells, lead to a significant reduction in tumor size and improvement in the visual status of controlled tumor foci relative to their initial state? 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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Results of the feasibility study of clinical trials of the new cancer treatment technology Karanahan for patients with advanced breast cancer.
   Proskurina AS, Markina VA, Ruzanova VS, Ritter GS, et al · · 2026 · PMID 42180943 · DOI 10.21037/tcr-2025-1-2722