Clinical trial NCT06361264: Clinical Study of Personalized Chemotherapy for Breast Cancer With Low Doses of Cyclophosphamide
Official title: Clinical Study of Personalized Chemotherapy for Breast Cancer With Low Doses of Cyclophosphamide, Taking Into Account the Reparative Cycle of Tumor Cells
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Stage IV Breast Cancer
Lead sponsor: KARANAHAN
Sponsor class: OTHER
First posted: 2024-04-11
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: The size of tumor foci
timeFrame: 2 months
Secondary outcomes:
measure: The quality of life score
timeFrame: 2 months
measure: The immunomodulatory effect
timeFrame: 2 months
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: Karanahan Llc
state: Novosibirsk Region
Study officials:
References: