Personalized chemotherapy for advanced breast cancer using low doses of cyclophosphamide

Clinical Study of Personalized Chemotherapy for Breast Cancer With Low Doses of Cyclophosphamide, Taking Into Account the Reparative Cycle of Tumor Cells

This study is testing if a personalized chemotherapy using low doses of cyclophosphamide can help people with advanced breast cancer feel better by tailoring treatment based on their tumor's specific characteristics.

Quick facts

• Phase: EARLY_PHASE1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: KARANAHAN (other)
• Drugs / interventions: cyclophosphamide, chemotherapy
• Locations: 1 site (Novosibirsk, Novosibirsk Region)
• Trial ID: NCT06361264 on ClinicalTrials.gov

What this trial studies

This clinical study evaluates the safety and effectiveness of personalized chemotherapy for patients with stage IV breast cancer, utilizing low doses of cyclophosphamide. The approach involves harvesting a tumor sample from participants to create a primary culture, which allows researchers to estimate the reparative cycle of tumor cells. Treatment is then tailored based on the synchronization of tumor cells at the G2/M phase of the cell cycle, aiming to reduce tumor size and improve the condition of tumor foci. The study seeks to determine if this personalized method leads to significant clinical benefits for participants.

Who should consider this trial

Good fit: Ideal candidates are individuals with stage IV breast cancer who have accessible tumor foci for biopsy and are aware of their disease prognosis.

Not a fit: Patients with severe organ failures, acute infections, or those intolerant to cyclophosphamide may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more effective and tailored treatment options for patients with advanced breast cancer.

How similar studies have performed: While personalized chemotherapy approaches have shown promise in other studies, this specific method using low doses of cyclophosphamide is relatively novel.

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.

Where this trial is running

Novosibirsk, Novosibirsk Region

• Karanahan Llc — Novosibirsk, Novosibirsk Region, Russian Federation (RECRUITING)

Study contacts

• Study coordinator: Anastasia Proskurina

Conditions: Stage IV Breast Cancer