Back to resultsAnti-Tumor Immunity Induced by Cryoablation of Invasive Breast Cancers
Primary Purpose
Breast Cancer
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cryoablation
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Ductal Histology, Unifocal, Estrogen Receptor Positive, her2neu negative
Eligibility Criteria
Inclusion Criteria:
- Subjects with an invasive breast cancer 1.5 cm or less
- The breast cancer must be of ductal histology, unifocal, estrogen receptor positive and her2/neu negative.
- The tumor must be visible by ultrasound and the subject must not have had prior surgical resection of the primary lesion.
- A clip marking the breast cancer must have been placed at the time of initial diagnosis or will be placed prior to cryotherapy.
- The breast cancer must be amenable to cryoablation (visible by ultrasound and more than 2 mm from skin or chest wall).
- Subjects with metastatic disease at diagnosis who elect to have their primary tumor excised are eligible for enrollment.
- For subjects with breast implants, the treating physician must document that adequate distance exists between the lesion and the implant to ensure that the ablated lesion with not contact or jeopardize the implant.
- Subjects must be able to provide consent.
Exclusion Criteria:
- Subjects with breast cancers of lobular histology, with lymph vascular invasion or extensive intraductal component will be excluded.
- Subjects with multi-centric or multi-focal breast cancers
- Subjects with breast cancers that have invaded skin or have significant skin tethering (assessed clinically).
- Subjects receiving chemotherapy within one year or undergoing neoadjuvant chemotherapy are excluded.
- Subjects with metastatic disease at diagnosis will be excluded unless they elect definitive surgical therapy for their primary lesion.
- Subjects with breast cancers not amenable to cryoablation (lesions not visible by ultrasound, against the chest wall or within 2 mm of skin) will be excluded.
- Subjects diagnosed with another malignancy in the preceding 5 years will be excluded.
- Subjects diagnosed with simultaneous bilateral breast cancer.
- Subjects receiving immunosuppressive therapy within 6 months including oral steroids will be excluded.
Sites / Locations
- Saint John's Health Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cryoablation
Arm Description
Cryoablation of breast cancer will be performed using a freeze-thaw technique and an IceCure probe. Cryoablation cycles will be determined by IceCure software programmed by the treating surgeon.
Outcomes
Primary Outcome Measures
Characterization of the intra-tumoral and systemic immune response to cryoablation in invasive breast cancers
Determine number (percentage via flow cytometry), phenotype and functionality of tumor infiltrating lymphocytes in ablated breast cancer
Determine number (percentage via flow cytometry)and phenotype of APC in ablated breast cancer
Characterize cytokine and chemokine expression (in IU) in ablated tissue and in pre-ablated and post-ablated serum over time
Quantify T cell response (IUs of IL2 and IFN gamma, and T cell specific cells as measured by number of spots on an elispot assay) to tumor associated antigens using in vitro assays of T cell proliferation and function (cytokine release, elispot, peptide-MHC)
Determine morphology and histology of regional lymph node after cryoablation
Secondary Outcome Measures
Comparison of the intra-tumoral and systemic response between non-ablated and ablated breast cancer and pre-ablated and post ablated serum
Difference in intra-tumoral lymphocyte populations (percentage via flow cytometry) in ablated and non-ablated breast cancers
Compare serum cytokine and chemokine expression (in IU) between patients undergoing or not undergoing tumor ablation
Compare intra-tumoral lymphocyte populations (percentage via flow cytometry) in ablated tumor tissue with paraffin embedded specimens for tumors that are matched for age, tumor size and histology.
Full Information
NCT ID
NCT01856036
First Posted
April 18, 2013
Last Updated
February 3, 2017
Sponsor
Saint John's Cancer Institute
1. Study Identification
Unique Protocol Identification Number
NCT01856036
Brief Title
Anti-Tumor Immunity Induced by Cryoablation of Invasive Breast Cancers
Official Title
CHUM-CRYOABLATION: Anti-Tumor Immunity Induced by Cryoablation of Invasive Breast Cancers
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Terminated
Why Stopped
PI left institute and contacted IRB to close study.
Study Start Date
April 2013 (Actual)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Saint John's Cancer Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This protocol will study the impact of cryoablation on immune response in patients diagnosed with invasive breast cancers smaller than 1.5 cm. It will profile the immune response to cryoablation of invasive breast cancers. The intra-tumoral and systemic immune response to cryoablation will be determined and compared to pre-ablated breast cancer specimens and historical control specimens.
Detailed Description
Patients with small breast cancers will undergo cryoablation of their breast cancer. Approximately six weeks after cryoablation, definitive breast surgery will be performed. Blood will be drawn for research before cryoablation and surgery and at regular follow-up visits. Blood and tissue samples will be used to determine immune responses.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Ductal Histology, Unifocal, Estrogen Receptor Positive, her2neu negative
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cryoablation
Arm Type
Experimental
Arm Description
Cryoablation of breast cancer will be performed using a freeze-thaw technique and an IceCure probe. Cryoablation cycles will be determined by IceCure software programmed by the treating surgeon.
Intervention Type
Procedure
Intervention Name(s)
Cryoablation
Intervention Description
Cryoablation of breast cancer will be performed using a freeze-thaw technique and an IceCure probe. Cryoablation cycles will be determined by IceCure software programmed by the treating surgeon.
Primary Outcome Measure Information:
Title
Characterization of the intra-tumoral and systemic immune response to cryoablation in invasive breast cancers
Description
Determine number (percentage via flow cytometry), phenotype and functionality of tumor infiltrating lymphocytes in ablated breast cancer
Determine number (percentage via flow cytometry)and phenotype of APC in ablated breast cancer
Characterize cytokine and chemokine expression (in IU) in ablated tissue and in pre-ablated and post-ablated serum over time
Quantify T cell response (IUs of IL2 and IFN gamma, and T cell specific cells as measured by number of spots on an elispot assay) to tumor associated antigens using in vitro assays of T cell proliferation and function (cytokine release, elispot, peptide-MHC)
Determine morphology and histology of regional lymph node after cryoablation
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
Comparison of the intra-tumoral and systemic response between non-ablated and ablated breast cancer and pre-ablated and post ablated serum
Description
Difference in intra-tumoral lymphocyte populations (percentage via flow cytometry) in ablated and non-ablated breast cancers
Compare serum cytokine and chemokine expression (in IU) between patients undergoing or not undergoing tumor ablation
Compare intra-tumoral lymphocyte populations (percentage via flow cytometry) in ablated tumor tissue with paraffin embedded specimens for tumors that are matched for age, tumor size and histology.
Time Frame
24 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects with an invasive breast cancer 1.5 cm or less
The breast cancer must be of ductal histology, unifocal, estrogen receptor positive and her2/neu negative.
The tumor must be visible by ultrasound and the subject must not have had prior surgical resection of the primary lesion.
A clip marking the breast cancer must have been placed at the time of initial diagnosis or will be placed prior to cryotherapy.
The breast cancer must be amenable to cryoablation (visible by ultrasound and more than 2 mm from skin or chest wall).
Subjects with metastatic disease at diagnosis who elect to have their primary tumor excised are eligible for enrollment.
For subjects with breast implants, the treating physician must document that adequate distance exists between the lesion and the implant to ensure that the ablated lesion with not contact or jeopardize the implant.
Subjects must be able to provide consent.
Exclusion Criteria:
Subjects with breast cancers of lobular histology, with lymph vascular invasion or extensive intraductal component will be excluded.
Subjects with multi-centric or multi-focal breast cancers
Subjects with breast cancers that have invaded skin or have significant skin tethering (assessed clinically).
Subjects receiving chemotherapy within one year or undergoing neoadjuvant chemotherapy are excluded.
Subjects with metastatic disease at diagnosis will be excluded unless they elect definitive surgical therapy for their primary lesion.
Subjects with breast cancers not amenable to cryoablation (lesions not visible by ultrasound, against the chest wall or within 2 mm of skin) will be excluded.
Subjects diagnosed with another malignancy in the preceding 5 years will be excluded.
Subjects diagnosed with simultaneous bilateral breast cancer.
Subjects receiving immunosuppressive therapy within 6 months including oral steroids will be excluded.
Facility Information:
Facility Name
Saint John's Health Center
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Anti-Tumor Immunity Induced by Cryoablation of Invasive Breast Cancers
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