Breast Cancer
Conditions
Keywords
cryoablation
Brief summary
The purpose of this study is to evaluate a new strategy to treat small breast cancer called cryoablation, or cryosurgery, in combination with biopsy methods which are guided by certain imaging like mammography.
Detailed description
For participants who choose to enroll in this study, the doctor will perform an excisional biopsy to remove the tumor (a biopsy to attempt to remove the whole tumor), after which a clip will be placed. Using the clip as a guide, the doctor will then cryoablate the biopsy cavity. Cryoablation is a kind of treatment that uses a hollow, thin tube, called a cryoprobe, to kill any residual tumor by freezing it. By conducting this study, the research team will investigate whether biopsy followed by cryoablation guided by mammography will prove to be an effective and safe way of treating breast cancers. It is anticipated that participation in this research will last about 2 years.
Interventions
DEVICEStereotactic Guided Biopsy and Cryoablation
Treatment of the lesion through a three-step procedure: 1) Tomosynthesis-guided stereotactic biopsy of the target (minimum 12 cores) which would include the initial tissue marking clip placed at time of initial diagnostic biopsy, then biopsy of the surrounding tissue using the same fixed sheath (minimum 12 cores) to allow for a better pathologic evaluation of extent of the target Ductal Carcinoma In Situ (DCIS). 2) Immediate cryoablation of biopsy site/cavity performed through the same sheath. 3) four post cryoablation biopsies through the same sheath to evaluate for any residual disease.
Sponsors
Montefiore Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 60 years or older, European Cooperative Oncology Group (ECOG) score 0-2 * Lesion size 1.0 cm or smaller in greatest diameter. The largest diameter will be determined at the time of the diagnostic work up. For targets that are imaged in multiple modalities the largest diameter will prevail in determining eligibility. Note- 1.0 cm target size is chosen since extent may be underestimated upon initial diagnosis. * Biopsy proven DCIS, (including any lesion with DCIS +/- IDC) * Closest margin of target to the skin \>15 mm * Compressed breast thickness to \> 55mm * Unifocal primary disease (Patients with contralateral disease will remain eligible.) * Able to provide consent
Exclusion criteria
* Multifocal or multicentric disease within the breast. * Prior surgical biopsy for diagnosis or treatment of index lesion. * Patients not suitable for stereotactic biopsy/cryoablation technique according to treating physician. * Patients receiving neoadjuvant therapy. * History of previously treated ipsilateral or contralateral breast carcinoma is not an exclusion criterion if the investigator is certain newly diagnosed carcinoma is a new unifocal primary tumor. * High-risk pathology (e.g., Grade 3, HER2+ status, Genomic high-risk score (if available)).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall feasibility | Up to 5 Years | Overall feasibility will be defined as study procedure completeness in more than 90% of enrolled patients AND data completeness in more than 90% of enrolled patients. |
| Feasibility - Procedure Completeness | Within 1 month post procedure (+/- 7 days) | Study procedure completeness feasibility will be defined as the patient's ability to tolerate the entire single procedure consisting of stereotactic biopsy of central target \& surrounding tissue + cryoablation of biopsy site/cavity + stereotactic biopsy (through the same sheath) of the post-cryoablation cavity. Study procedure completeness feasibility will be considered to have been met if \> 90% of enrolled patients complete the procedure. |
| Feasibility - Data Completeness | Up to 5 Years | Data completeness feasibility will be defined as the ability to complete data collection from patients on study procedure, adverse events, follow-up imaging assessment, and tumor recurrence assessment elements. Data completeness feasibility will be considered to be met if these elements are collected in \> 90% of enrolled patients. |
| Study Safety | Day of procedure and within 1-month post-procedure (+/- 7 days) | Study safety will be defined as ≤ 10% of patients having experienced serious adverse events that are either possibly or definitely related to the 3-step procedure (i.e., ≤ 2 patients in the entire study) AND ≤ 15% of patients experiencing moderate or severe adverse events (i.e., the Common Terminology Criteria for Adverse Events v 5.0) (CTCAE) Grades 3-5 that are either possibly or probably related to the 3-step procedure (i.e., ≤ 3 patients in the entire study). For purposes of this study, cancer recurrence will be identified as a serious adverse event due to its life-threatening nature. All patients that begin the 3-step procedure will be included in the safety analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility Outcomes - Removal of biopsy clip | Within 1 month post procedure (+/- 7 days) | Removal of the cryoablation biopsy clip from the central target lesion will be analyzed as the proportion of patients who had clip removed relative to all patients who participated in the study. Successful targeting and removal of the cryoablation biopsy clip in ≥ 90% of patients who participated in the study is the threshold for this feasibility outcome. |
| Feasibility Outcomes - Negative margins | Within 1 month post procedure (+/- 7 days) | Negative (clean) margins will be defined as no tumor seen in the surrounding tissue by pathological evaluation following the procedure. Negative margins will be analyzed as the proportion of patients with negative margins relative to all patients who participated in the study. Negative margins (as determined by biopsies of surrounding tissue upon pathological assessment) observed in ≥ 90% of patients who participate in the study is the threshold for this feasibility outcome. |
| Feasibility Outcomes - Local recurrence | 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, and 60 months | Local recurrence will be defined as evidence of invasive or in situ breast cancer in the ipsilateral breast or chest wall. Patients who develop clinical evidence of tumor recurrence in the remainder of the breast or chest wall will be recommended to have a biopsy of the suspicious lesion to confirm the diagnosis. If a biopsy is not performed for any reason, an imaging designation of BIRADS 4 and 5 will be considered evidence of disease recurrence. Given the challenges of reliably defining local recurrence vs. new primary, all recurrences in the ipsilateral breast will be considered in the analysis of local recurrence. Local recurrence will be evaluated in patients for 5 years after study procedure using Kaplan-Meier methods. |
| Patient satisfaction questionnaire - time | Within 7 days of procedure | Patient satisfaction related to the time necessary to complete the procedure will be evaluated via administration of a questionnaire. Patients will be asked to rate satisfaction of the time needed based on a 5-point scale ranging from 1 ("Very Dissatisfied") to 5 ("Very Satisfied"), such that higher scores are indicative of better satisfaction with the time needed to complete the procedure. |
| Procedural Pain - questionnaire | Within 7 days of procedure | Pain associated with the procedure will be evaluated via administration of a questionnaire. Patients will be asked to rate pain associated with the procedure based on a 6-point scale ranging from 1 ("No pain") to 5 ("Worst pain possible"), such that lower scores are indicative of less pain severity in association with the procedure. |
| Procedural symptoms - questionnaire | Within 7 days of procedure | Symptom severity associated with the procedure will be evaluated via administration of a questionnaire. Patients will be asked to rate the severity of their symptoms using a 4-point scale ranging from 1 ("Mild") to 4 ("Very Severe"), such that lower scores are indicative of less symptom severity associated with the procedure. |
| Patient satisfaction with breasts - preoperatively | Within 7 days of procedure | Patient satisfaction with breasts prior to treatment will be evaluated using Version 2.0 of the Breast-Q 'Satisfaction with Breasts' module. The preoperative Breast-Q module consists of 4 questions which asks patients to describe how satisfied/dissatisfied they have been over the past week with their breasts. The 4 responses are rated using a 4-point scale ranging from 1 ("Very Dissatisfied") to 4 ("Very Satisfied"), yielding a raw sum score of 4-16. Raw Breast-Q sum scores are then converted using a validated "Equivalent Rasch Transformed Score" table ranging from 0-100 such that higher Rasch scores are indicative of a better outcome. If missing data comprises \<50% of the scale's items, the mean of the missing items is inserted into the table. |
| Patient satisfaction with breasts - postoperatively | Within 7 days of procedure and within 1 year (+/- 1 month) post procedure | Patient satisfaction with breasts and breast cancer treatment prior following the procedure will be evaluated using Version 2.0 of the Breast-Q breast cancer treatment (BCT) module. This Breast-Q module consists of 11 questions which ask patients to describe how satisfied/dissatisfied they have been over the past week with respect to their breasts and breast cancer treatment. The 11 responses are rated using a 4-point scale ranging from 1 ("Very Dissatisfied") to 4 ("Very Satisfied"), yielding an overall sum score of 11-44. Raw Breast-Q sum scores are then converted using a validated "Equivalent Rasch Transformed Score" table ranging from 0-100 such that higher Rasch scores are indicative of a better outcome. If missing data comprises \<50% of the scale's items, the mean of the missing items is inserted into the table. |
Contacts
PRINCIPAL_INVESTIGATORLaura A Hodges, MD
Montefiore Medical Center
Outcome results
None listed