Cryoablation vs Lumpectomy in T1 Breast Cancers
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age50+
SponsorWashington University School of Medicine
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of invasive ductal carcinoma of the breast (ER , Her-2 negative) that is grade 1 or 2 with intraductal component <25%. Must be T1N0M0 (2 cm or less).
If DCIS is present in the biopsy specimen it should be <25% 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<6/8 and T1c tumors. Oncotype score in this subset of patients must be <26 to be included in the trial.
At least 50 years of age.
Disqualifiers
Indication for neoadjuvant chemotherapy.
Prior history of breast cancer.
Breast augmentation.
Allergy to local anesthetics.
Trial design
Design model
Parallel
Treatments tested in this trial
Endocare SlimLine Cryoprobe
DeviceThe 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. The 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/ablate tissue by the application of extreme cold temperatures.
Lumpectomy
Procedure/SurgeryPatients randomized to cryoablation who experience disease recurrence may undergo crossover to lumpectomy.
Treatment groups
120 Participants
are divided into 4 treatment groupsGroup A: CryoablationExperimental treatment 1 intervention
Group B: LumpectomyActive comparator 1 intervention
Group C: Rescue Arm: LumpectomyOther 1 intervention
Group D: Cryoablation - Safety Lead InExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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/incapacity, 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.
Time frame
Assessed from start of treatment through 30 days after cryoablation treatment (estimated to be 31 days)2
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.
Time frame
At 5 years.Secondary outcomes
1
Proportion of patients who are free of serious 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/incapacity, 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.
Time frame
Assessed from start of treatment through 30 days after cryoablation treatment (estimated to be 31 days)2
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.
Time frame
Through 5 years.3
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.
Time frame
Through 5 years.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Washington University School of Medicine
Lead sponsor
The Foundation for Barnes-Jewish Hospital
Collaborator
Varian Medical Systems
Collaborator
Source ClinicalTrials.gov