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

NCT05806385 | Not Yet Recruiting Phase 1 DMC FDA Drug FDA Device

• 1 other identifier: L21-076
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

Summary Points:

1. 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. 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. 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. 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.

Conditions

Triple Negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Rate of Complete Pathological Response

  Pathological analysis of tumor after completion of local and neoadjuvant therapy

  6-8 months

Secondary Outcomes (1)

• Percent change is Tumor Infiltrating Lymphocytes Score

  6-8 month

Study Arms (3)

Standard of Care Arm:

NO INTERVENTION

Control arm: Stage I/II TNBC patients will receive neoadjuvant chemotherapy followed by lumpectomy/mastectomy with sentinel node biopsy +/- axillary dissection.

Intervention 1

EXPERIMENTAL

Cryoablation Alone Arm: Intervention with cryoablation alone followed by neoadjuvant chemotherapy followed by lumpectomy/mastectomy with sentinel node biopsy +/- axillary dissection.

Device: Cryoablation

Intervention 2

EXPERIMENTAL

Cryoablation + PD1 Inhibitor Arm: Intervention with cryoablation + Pembrolizumab followed by neoadjuvant chemotherapy followed by lumpectomy/mastectomy with sentinel node biopsy +/- axillary dissection.

Combination Product: Cryoablation combined with PD1 Inhibitor

Interventions

Cryoablation DEVICE

Tumor ablation before neoadjuvant chemotherapy

Intervention 1

Cryoablation combined with PD1 Inhibitor COMBINATION_PRODUCT

Combination of cryoablation with PD1 inhibitor before neoadjuvant chemotherapy

Intervention 2

Eligibility Criteria

• Age: 18 Years - 90 Years
• Gender Eligibility Details: Women with Breast Cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females
• Stage I/II Cancer
• Age range 18 - 90 years
• Diagnoses: Invasive carcinoma, ER -, PR-, HER2- (triple negative)
• Radiology findings: Unifocal disease visible on ultrasound

You may not qualify if:

• Additional primary cancer
• Inflammatory breast cancer
• History of autoimmune disease
• History of chronic immunosuppression
• Prior immunotherapy
• Recent vaccination (within 4 wks.)
• Prior radiation therapy
• Prior investigational agent therapy within last 1 year
• Pregnancy at the time of diagnosis and/ or treatment
• Breast feeding

Sponsors & Collaborators

• Texas Tech University Health Sciences Center: lead

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

Cryosurgery; Immune Checkpoint Inhibitors

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Central Study Contacts

Rakhshanda Layeequr Rahman, MD

CONTACT

806-743-2289; rakhshanda.rahman@ttuhsc.edu

Sharda Singh, PHD

CONTACT

806-743-1540; sharda.singh@ttuhsc.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Since proposed intervention ( cryoablation and immune therapy infusion) cannot be masked with placebo, only the data analyst will be masked.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Surgical Oncology

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: March 28, 2023
• First Posted: April 10, 2023
• Study Start: March 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2029
• Last Updated: September 9, 2025

Record last verified: 2025-09