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

Early Phase 1

Recruiting

• Conditions: Stage IV Breast Cancer
• Interventions: Combination Product: Karanahan

• Registration Number: NCT06361264
• Lead Sponsor: KARANAHAN

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-01
• Status Verified: 2024-04
• Study First Submitted: 2024-04-02
• Study First Submitted QC: 2024-04-08
• Last Update Submitted: 2024-04-08
• Study First Posted: 2024-04-11
• Last Update Posted: 2024-04-11
• Primary Completion: 2024-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Karanahan	Karanahan	Reparative cycle of tumor cells is assessed at the preliminary stage in in vitro culture. According to the elaborated regimen, the patient 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.

Primary Outcome Measures

Name	Time	Method
The size of tumor foci	2 months	Estimation of the size and visual condition of controlled tumor foci relative to their initial state. Tumor response assessment using the Response Evaluation Criteria In Solid Tumors (RECIST 1.1).

Secondary Outcome Measures

Name	Time	Method
The quality of life score	2 months	Changes in participants' quality of life during the therapy (score) according to the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30, version 3.0). The scale ranges in score from 0 to 100. Higher score means higher quality of life.
The immunomodulatory effect	2 months	The number of CD4+CD25+FoxP3+ regulatory T cells and CD8+CD107a+ T cells is mesuared in participants' blood before therapy and after 2 months using corresponding antibodies. Increase in number of these cells by 14% or more means the development of the adaptive antitumor immune response.

Trial Locations

Locations (1)

Karanahan Llc; 🇷🇺 Novosibirsk, Novosibirsk Region, Russian Federation