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

Sponsor
Texas Tech University Health Sciences Center
Study ID
NCT05806385
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Cryoablation — DEVICE
    Tumor ablation before neoadjuvant chemotherapy
  • Cryoablation combined with PD1 Inhibitor — COMBINATION_PRODUCT
    Combination of cryoablation with PD1 inhibitor before neoadjuvant chemotherapy

Study Details

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.

Key Dates

First listed
Apr 10, 2023
Start date
Mar 31, 2026
Status verified
Sep 2025
Primary completion
Jan 31, 2027
Completion
Jun 30, 2029

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • No Intervention: Standard of Care Arm:
    Control arm: Stage I/II TNBC patients will receive neoadjuvant chemotherapy followed by lumpectomy/mastectomy with sentinel node biopsy +/- axillary dissection.
  • Experimental: Intervention 1
    Cryoablation Alone Arm: Intervention with cryoablation alone followed by neoadjuvant chemotherapy followed by lumpectomy/mastectomy with sentinel node biopsy +/- axillary dissection.
  • Experimental: Intervention 2
    Cryoablation + PD1 Inhibitor Arm: Intervention with cryoablation + Pembrolizumab followed by neoadjuvant chemotherapy followed by lumpectomy/mastectomy with sentinel node biopsy +/- axillary dissection.

Primary Outcome Measure

Rate of Complete Pathological Response [ Time Frame: 6-8 months ]

Central Contacts

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