Breast CancerNCT01856036
Anti-Tumor Immunity Induced by Cryoablation of Invasive Breast Cancers
A study testing Cryoablation in people with Breast Cancer, run by Saint John's Cancer Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Cryoablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Saint John's Health Center
Santa Monica, California, 90404
About this study
Official title: CHUM-CRYOABLATION: Anti-Tumor Immunity Induced by Cryoablation of Invasive Breast Cancers
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Cryoablation
- Keywords
- Ductal Histology, Unifocal, Estrogen Receptor Positive, her2neu negative
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryoablationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Cryoablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
- 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.
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2013 (estimated)
- Study startApr 2013
- Primary completionOct 2014
- Study completionOct 2014
Why it stopped: PI left institute and contacted IRB to close study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint John's Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01856036
- Sponsor's protocol ID
- CHUM-CRYOABLATION
- Status last verified
- Feb 2017
- First submitted
- 18 Apr 2013
- Last updated
- 7 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CHUM-CRYOABLATION: Anti-Tumor Immunity Induced by Cryoablation of Invasive Breast Cancers
- ClinicalTrials.gov ID
- NCT01856036
- Acronym / sponsor ID
- CHUM-CRYOABLATION
- Conditions
- Breast Cancer
- Keywords
- Ductal Histology, Unifocal, Estrogen Receptor Positive, her2neu negative
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI left institute and contacted IRB to close study.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Saint John's Cancer InstituteUniversity, hospital or other
- Study start
- Apr 2013 (actual)
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 17 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cryoablation | Experimental | Procedure: CryoablationCryoablation 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CryoablationCryoablation 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 or surgery | Cryoablation |
Primary outcome
Characterization of the intra-tumoral and systemic immune response to cryoablation in invasive breast cancers
Time frame: 12 Months
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
1 secondary outcome
Comparison of the intra-tumoral and systemic response between non-ablated and ablated breast cancer and pre-ablated and post ablated serum
Time frame: 24 Months
Results and safety
The study was stopped early (reason given: PI left institute and contacted IRB to close study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryoablation in people with Breast Cancer, run by Saint John's Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: PI left institute and contacted IRB to close study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of the intra-tumoral and systemic immune response to cryoablation in invasive breast cancers (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2017.