Clinical trial NCT01856036: 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
Overall status: TERMINATED
Phase: NA
Conditions: Breast Cancer
Keywords: Ductal Histology
Unifocal
Estrogen Receptor Positive
her2neu negative
Lead sponsor: Saint John's Cancer Institute
Sponsor class: OTHER
First posted: 2013-05-17
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Subjects with an invasive breast cancer 1.5 cm or less
2. The breast cancer must be of ductal histology, unifocal, estrogen receptor positive and her2/neu negative.
3. The tumor must be visible by ultrasound and the subject must not have had prior surgical resection of the primary lesion.
4. A clip marking the breast cancer must have been placed at the time of initial diagnosis or will be placed prior to cryotherapy.
5. The breast cancer must be amenable to cryoablation (visible by ultrasound and more than 2 mm from skin or chest wall).
6. Subjects with metastatic disease at diagnosis who elect to have their primary tumor excised are eligible for enrollment.
7. 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.
8. Subjects must be able to provide consent.

Exclusion Criteria:

1. Subjects with breast cancers of lobular histology, with lymph vascular invasion or extensive intraductal component will be excluded.
2. Subjects with multi-centric or multi-focal breast cancers
3. Subjects with breast cancers that have invaded skin or have significant skin tethering (assessed clinically).
4. Subjects receiving chemotherapy within one year or undergoing neoadjuvant chemotherapy are excluded.
5. Subjects with metastatic disease at diagnosis will be excluded unless they elect definitive surgical therapy for their primary lesion.
6. 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.
7. Subjects diagnosed with another malignancy in the preceding 5 years will be excluded.
8. Subjects diagnosed with simultaneous bilateral breast cancer.
9. Subjects receiving immunosuppressive therapy within 6 months including oral steroids will be excluded.

Primary outcomes:
measure: Characterization of the intra-tumoral and systemic immune response to cryoablation in invasive breast cancers
timeFrame: 12 Months
Secondary outcomes:
measure: Comparison of the intra-tumoral and systemic response between non-ablated and ablated breast cancer and pre-ablated and post ablated serum
timeFrame: 24 Months
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Saint John's Health Center
state: California
Study officials:
References: