Cryoablation Therapy in Treating Patients With Invasive Ductal Breast Cancer

Study Overview
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Brief Summary
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This phase II trial is studying how well cryoablation therapy works in treating patients with invasive ductal breast cancer. Cryoablation kills tumor cells by freezing them. This may be an effective treatment for patients with invasive ductal breast cancer.

Detailed Description
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This is a phase II non-randomized exploratory study. All fully eligible and registered patients will undergo imaging by mammography, ultrasound, and breast MRI. Patients will then undergo complete surgical resection of the primary tumor. The primary and secondary objectives of the study are described below. OBJECTIVES: Primary To determine the rate of complete tumor ablation in patients treated with cryoablation, with complete tumor ablation defined as no remaining invasive or in situ carcinoma present upon pathological examination of the targeted lesion Secondary To evaluate the negative predictive value of MRI in the post-ablation setting to determine residual in situ or invasive breast carcinoma To describe the adverse events associated with cryoablation To prospectively gather pain assessment data on cryoablation and surgical resection Explore technical variables that may affect the success of cryoablation

Official Title
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A Phase II Trial Exploring the Success of Cryoablation Therapy in the Treatment of Invasive Breast Carcinoma

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: cryosurgery
* Procedure: therapeutic conventional surgery


Participation Criteria
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Eligibility Criteria
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Unifocal primary invasive ductal breast carcinoma diagnosed by core needle biopsy. NOTE: Patients with lobular carcinoma, multifocal and/or multicentric ipsilateral breast cancer, multifocal calcifications, or DCIS with microinvasion are NOT eligible. Patients with contralateral disease will remain eligible. No history of en bloc open surgical biopsy and/or lumpectomy for diagnostic/treatment of the index breast cancer. Note: Prior rotational and/or vacuum-assisted core biopsies are permitted if no significant distortion is seen on imaging that could obscure visualization and detection of residual disease on MRI, or visualization of cancer on ultrasound for cryoablation procedure. Tumor size ≤ 2.0 cm in greatest diameter. Specifically, the tumor must measure ≤ 2.0 cm in the axis parallel to the treatment probe and ≤ 1.5 cm in the axis anti-parallel to the treatment probe. Largest size measured by required scans (mammogram, ultrasound and MRI) will be used to determine eligibility. Tumor enhancement on pre-study MRI. Tumor with < 25% intraductal components in the aggregate. NOTE: The percent intraductal component from the patient's diagnostic biopsy must be available prior to registration. If the biopsy pathology report does not contain the percent intraductal component, then re-review of pathology slides and creation of a report addendum or note-to-file by the reviewing pathologist will be required. No prior or planned neoadjuvant chemotherapy for breast cancer. Non-pregnant and non-lactating. Patients of childbearing potential must have a negative serum or urine pregnancy test. NOTE: Peri-menopausal women must be amenorrheic for > 12 months to be considered not of childbearing potential. Adequate breast size for safe cryoablation. Male breast cancer patients and female breast cancer patients with breasts too small to allow safe cryoablation are not eligible as the minimal thickness of the breast tissue does not lend itself to cryoablation. NOTE: For patients with breast implants, the treating physician must document that adequate distance exists between the lesion and the implant to ensure that the ablated lesion will not contact or jeopardize the implant. Patients with prior in-situ or invasive breast carcinomas are eligible if the prior carcinomas occurred in the contralateral breast. Patients with prior in-situ or invasive carcinomas of the ipsilateral breast are not eligible.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (cryoablation)<br>A cryoprobe is inserted percutaneously under ultrasound guidance into the targeted lesion. Patients undergo ablation using a freeze-thaw-freeze cycle lasting approximately 6-10-6 or 8-10-8 minutes, respectively. Patients undergo surgical resection and sentinel lymph node biopsy and/or axillary dissection within 28 days after completion of cryoablation. Patients complete the Brief Pain Inventory before and after cryoablation and after surgery. | Procedure: cryosurgery<br> <br> Procedure: therapeutic conventional surgery<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Complete Tumor Ablation | The primary endpoint for this study is the rate of complete ablation. Complete ablation is defined as no remaining invasive or in situ carcinoma present upon pathological examination of the targeted lesion. The rate (percentage) will be computed as the number of patient lesions with complete tumor ablation divided by the total number of eligible patient lesions. This rate will be estimated by the binomial point estimate (number of patients with no pathological evidence of residual disease in the targeted lesion after ablation divided by the number of eligible patients) and a one-sided 90% binomial confidence interval (interval with a lower bound). | Up to 14 days post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Negative Predictive Value of MRI | Negative predictive value of MRI: The negative predictive rate of MRI will be estimated as the number of patients with no residual disease upon pathologic review of the resected tissue AND with a MRI that indicated no residual disease divided by the number of patients who had an MRI that indicated no residual disease. Both a binomial point estimate and 90% two-sided confidence interval will be computed. | Up to 14 days post cryoablation | 
| Adverse Events |  | Up to 14 days post surgery | 
| Pain Assessment |  | Up to 14 days post surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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invasive ductal breast carcinoma, male breast cancer, stage IA breast cancer, stage IB breast cancer, stage II breast cancer