NCT05806385Not yet recruitingPhase 1/2
Grouping Immune-modulation With Cryoablation (LOGIC) for Breast Cancers
Local Therapy Optimization by Grouping Immune-modulation With Cryoablation (LOGIC) for High Risk Breast Cancers
Source: ClinicalTrials.gov · Last updated 9 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- First submitted
- 28 Mar 2023
- Start date
- Mar 2026
- Primary completion date
- Jan 2027
- Lead sponsor
- Texas Tech University Health Sciences Center
- Diseases
- Triple-negative breast cancer
- NCT number
- NCT05806385
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 36
- From Mar 2026 to the primary completion date, Jan 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior immunotherapy
- Prior radiation therapy
- Prior investigational agent therapy within last 1 year
Other illness
- Additional primary cancer
- Inflammatory breast cancer
- History of autoimmune disease
- History of chronic immunosuppression
Other
- Recent vaccination (within 4 wks.)
- Pregnancy at the time of diagnosis and/ or treatment
- Breast feeding
Who the study is looking for
- 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
Age in the registry: 18 years to 90 years · Sex: Female · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.