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NOT YET RECRUITING
NCT05806385
PHASE1/PHASE2

Grouping Immune-modulation With Cryoablation (LOGIC) for Breast Cancers

Sponsor: Texas Tech University Health Sciences Center

View on ClinicalTrials.gov

Summary

Summary Points: 1. High Risk Breast Cancers: Triple negative cancer is considered high risk due to high rate of local and systemic failure. Newer innovative treatment strategies are needed to improve systemic control of disease and survival. 2. Immune system modulation: is an emerging modality in cancer treatment. Tumor antigens can stimulate T cells to identify and destroy cancer cells. Cancers express "altered self" antigens that tend to induce weaker responses than the "foreign" antigens expressed by infectious agents. Thus, immune stimulants and adjuvant approaches have been explored widely. Opportunities to develop effective cancer vaccines may benefit from seminal recent advances in understanding how immunosuppressive barricades are erected by tumors to mediate immune escape. This concept is precisely applicable to triple negative breast cancer due to their antigenicity. Checkpoint inhibitors are an attractive method for treatment of high-risk breast cancers. However, to leverage the efficacy of checkpoint inhibition, approaches are needed to enhance delivery of cancer antigens to the T cells. 3. Cryoablation: offers an efficacious and safe method to enhance tumor antigen presentation to the immune cells while destroying the primary tumor. This ablation method is superior by virtue of antigen preservation in situ despite toxicity to the tumor cell. Impact of cryoablation in enhancing immunological responses in tumor microenvironment are well established; however, cryoablation can also cause tumor antigen tolerance via non-specific stimulation of T cells. 4. Rationale for combining cryoablation and checkpoint inhibitors: Since checkpoint inhibitors curtail the tolerance developed by tumor antigens, and cryoablation enhances antigen presentation and T cell recruitment, it is intuitive that combination of these two approaches presents an ideal opportunity to leverage the benefits of both approaches while curtailing the limitations of either. Therefore, the investigators hypothesize in this study that their combination will improve the response rate and the degree of response.

Official title: Local Therapy Optimization by Grouping Immune-modulation With Cryoablation (LOGIC) for High Risk Breast Cancers

Key Details

Gender

FEMALE

Age Range

18 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2026-03

Completion Date

2029-06

Last Updated

2025-09-09

Healthy Volunteers

No

Interventions

DEVICE

Cryoablation

Tumor ablation before neoadjuvant chemotherapy

COMBINATION_PRODUCT

Cryoablation combined with PD1 Inhibitor

Combination of cryoablation with PD1 inhibitor before neoadjuvant chemotherapy