[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05505643":3,"trial-entities:NCT05505643":130,"trial-summary:NCT05505643":135},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":46,"secondary_outcomes":55,"sex":65,"minimum_age":66,"maximum_age":17,"healthy_volunteers":67,"eligibility_criteria":68,"std_ages":84,"locations":87,"central_contacts":121,"overall_officials":123,"references":125,"see_also_links":126},"NCT05505643","202302017","Cryoablation vs Lumpectomy in T1 Breast Cancers","COOL-IT: Cryoablation vs Lumpectomy in T1 Breast Cancers: A Randomized Controlled Trial With Safety Lead-in","RECRUITING","2033-04-30","2026-02","2026-02-27","2024-04-03","Washington University School of Medicine","OTHER",true,"This trial studies the efficacy and safety of cryoablation in patients with low risk, early stage breast cancer. Cryoablation is a method of killing a tumor by freezing it. The standard approach for patients with this kind of cancer is a lumpectomy. This study will review the safety of the cryoablation procedure initially, followed by comparing cryoablation to lumpectomy in order to see if the cryoablation results in better disease control, complication rates, and quality of life.",null,[19,20],"Breast Cancer","Breast Neoplasm",[22,23,24],"breast cancer","cryoablation","lumpectomy","INTERVENTIONAL","TREATMENT",[28],"NA",{"count":30,"type":31},120,"ESTIMATED",[33,40],{"type":34,"name":35,"description":36,"armGroupLabels":37},"DEVICE","Endocare SlimLine Cryoprobe","The Endocare(TM) SlimLine (TM) Cryoprobe is a single use, disposable device designed for use with Endocare Cryocare Surgical Systems. Endocare cryoprobes are designed to deliver cold temperatures for cryoablation using high-pressure argon gas circulated through the cryoprobe, followed by active thawing using helium gas.\n\nThe Cryocare CS Surgical System is intended for use in open, minimally invasive, or endoscopic surgical procedures in the areas of general surgery, urology, gynecology, oncology, neurology, dermatology, ENT, proctology, pulmonary surgery, and thoracic surgery. The system is designed to freeze\u002Fablate tissue by the application of extreme cold temperatures.",[38,39],"Cryoablation","Cryoablation - Safety Lead In",{"type":41,"name":42,"description":43,"armGroupLabels":44},"PROCEDURE","Lumpectomy","Patients randomized to cryoablation who experience disease recurrence may undergo crossover to lumpectomy.",[42,45],"Rescue Arm: Lumpectomy",[47,51],{"measure":48,"description":49,"timeFrame":50},"Safety Lead-In: Number of treatment-related complications","Excessive adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0. They are defined as toxicities occurring within 30 days after the cryoablation procedure and are at least possibly related to the cryoablation. These include death, life-threatening adverse events, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability\u002Fincapacity, or complications related to cryoablation which interfere with adjuvant therapy such that the adjuvant therapy cannot be performed at all or delayed for a period longer than 6 months or which result in unplanned mastectomy.","Assessed from start of treatment through 30 days after cryoablation treatment (estimated to be 31 days)",{"measure":52,"description":53,"timeFrame":54},"Randomized Controlled Trial: Ipsilateral breast cancer recurrence (IBTR) in the treated breast.","IBTR defined from date of procedure to date of ipsilateral breast cancer recurrence, with the occurrence of ipsilateral breast tumor recurrence as the event and patients will be censored at the last follow-up.","At 5 years.",[56,58,62],{"measure":57,"description":49,"timeFrame":50},"Proportion of patients who are free of serious treatment-related complications",{"measure":59,"description":60,"timeFrame":61},"Proportion of patients who demonstrate disease-free survival (DFS)","DFS is defined as the time from procedure to time of ipsilateral recurrence, contralateral recurrence, regional recurrence or distant metastasis, or date of last follow-up if none of the recurrence events occur.","Through 5 years.",{"measure":63,"description":64,"timeFrame":61},"Overall survival (OS)","OS is defined from date of procedure to date of death or date of last follow up if none of the recurrence events occur.","FEMALE","50 Years",false,{"inclusion":69,"exclusion":76,"raw_text":83},[70,71,72,73,74,75],"Diagnosis of invasive ductal carcinoma of the breast (ER , Her-2 negative) that is grade 1 or 2 with intraductal component \\\u003C25%. Must be T1N0M0 (2 cm or less).","If DCIS is present in the biopsy specimen it should be \\\u003C25% of the tumor and should be contiguous with the IDC. (i.e. DCIS should not be a separate tumor from the IDC).","Oncotyping will be performed on T1b+Allred\\\u003C6\u002F8 and T1c tumors. Oncotype score in this subset of patients must be \\\u003C26 to be included in the trial.","At least 50 years of age.","Negative ipsilateral axillary assessment as determined either by (1) negative axillary ultrasound (2) negative sentinel lymph node biopsy or (3) negative percutaneous axillary node biopsy with no further clinical or imaging concern for nodal metastatic disease.","Able to understand and willing to sign an IRB-approved written informed consent document.",[77,78,79,80,81,82],"Indication for neoadjuvant chemotherapy.","Prior history of breast cancer.","Breast augmentation.","Allergy to local anesthetics.","Pregnant or lactating. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.","Tumoral involvement of skin or chest wall.","Inclusion Criteria:\n\n* Diagnosis of invasive ductal carcinoma of the breast (ER , Her-2 negative) that is grade 1 or 2 with intraductal component \\\u003C25%. Must be T1N0M0 (2 cm or less).\n* If DCIS is present in the biopsy specimen it should be \\\u003C25% of the tumor and should be contiguous with the IDC. (i.e. DCIS should not be a separate tumor from the IDC).\n* Oncotyping will be performed on T1b+Allred\\\u003C6\u002F8 and T1c tumors. Oncotype score in this subset of patients must be \\\u003C26 to be included in the trial.\n* At least 50 years of age.\n* Negative ipsilateral axillary assessment as determined either by (1) negative axillary ultrasound (2) negative sentinel lymph node biopsy or (3) negative percutaneous axillary node biopsy with no further clinical or imaging concern for nodal metastatic disease.\n* Able to understand and willing to sign an IRB-approved written informed consent document.\n\nExclusion Criteria:\n\n* Indication for neoadjuvant chemotherapy.\n* Prior history of breast cancer.\n* Breast augmentation.\n* Allergy to local anesthetics.\n* Pregnant or lactating. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.\n* Tumoral involvement of skin or chest wall.",[85,86],"ADULT","OLDER_ADULT",[88],{"facility":13,"status":8,"city":89,"state":90,"zip":91,"country":92,"contacts":93,"geoPoint":118},"St Louis","Missouri","63110","United States",[94,99,101,104,106,108,110,112,114,116],{"name":95,"role":96,"phone":97,"email":98},"Heather Garrett, M.D.","CONTACT","636-916-9662","hvgarrett@wustl.edu",{"name":95,"role":100},"PRINCIPAL_INVESTIGATOR",{"name":102,"role":103},"Robert McKinstry, M.D.","SUB_INVESTIGATOR",{"name":105,"role":103},"Debbie Bennett, M.D.",{"name":107,"role":103},"Julie Margenthaler, M.D.",{"name":109,"role":103},"Katherine Clifton, M.D.",{"name":111,"role":103},"Jingqin Luo, Ph.D.",{"name":113,"role":103},"Christina Doherty, M.D.",{"name":115,"role":103},"Tabassum Ahmad, M.D.",{"name":117,"role":103},"Imran Zoberi, M.D.",{"lat":119,"lon":120},38.62727,-90.19789,[122],{"name":95,"role":96,"phone":97,"email":98},[124],{"name":95,"affiliation":13,"role":100},[],[127],{"label":128,"url":129},"Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine","http:\u002F\u002Fwww.siteman.wustl.edu",{"nct_id":4,"conditions":131,"biomarkers":133},[132],"Breast Carcinoma",[134],"Oncotype",{"nct_id":4,"found":15,"summary":136,"prompt_version":146},{"design":137,"status":138,"heading":139,"summary":140,"follow_up":141,"word_count":142,"commitments":143,"compensation":144,"drugs_mentioned":145},"This is an interventional study planning to enroll 120 participants. It will compare cryoablation to lumpectomy.","completed","Cryoablation vs. Lumpectomy for Early Breast Cancer","This study is comparing two ways to treat early-stage breast cancer: cryoablation (freezing the tumor) and lumpectomy (surgically removing the tumor). The goal is to see if cryoablation is as safe and effective as lumpectomy for certain types of breast cancer. You might be able to join if you are a woman aged 50 or older with a specific type of invasive ductal carcinoma (ER+, Her-2 negative, grade 1 or 2, T1N0M0, 2 cm or less). The study will look at how often breast cancer comes back in the treated breast after 5 years, as well as complication rates and quality of life. The current recruitment status is unclear.","Participants will be followed for 5 years to assess for breast cancer recurrence.",109,"Not specified in the trial record.","Not stated in the trial record.",[42],"v2"]