Anti-Tumor Immunity Induced by Cryoablation of Invasive Breast Cancers

NCT01856036 | Terminated

• 1 other identifier: CHUM-CRYOABLATION
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Ductal Histology; Unifocal; Estrogen Receptor Positive; her2neu negative

Outcome Measures

Primary Outcomes (1)

• Characterization of the intra-tumoral and systemic immune response to cryoablation in invasive breast cancers

  1. Determine number (percentage via flow cytometry), phenotype and functionality of tumor infiltrating lymphocytes in ablated breast cancer 2. Determine number (percentage via flow cytometry)and phenotype of APC in ablated breast cancer 3. Characterize cytokine and chemokine expression (in IU) in ablated tissue and in pre-ablated and post-ablated serum over time 4. 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) 5. Determine morphology and histology of regional lymph node after cryoablation

  12 Months

Secondary Outcomes (1)

• Comparison of the intra-tumoral and systemic response between non-ablated and ablated breast cancer and pre-ablated and post ablated serum

  24 Months

Study Arms (1)

Cryoablation

EXPERIMENTAL

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.

Procedure: Cryoablation

Interventions

Cryoablation PROCEDURE

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.

Cryoablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Saint John's Cancer Institute: lead

Study Sites (1)

Saint John's Health Center

Santa Monica, California, 90404, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Cryosurgery

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2013
• First Posted: May 17, 2013
• Study Start: April 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: February 7, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)