Breast Cancer, Breast Neoplasm
Conditions
Keywords
breast cancer, cryoablation, lumpectomy
Brief summary
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.
Interventions
DEVICEEndocare 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. 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.
PROCEDURELumpectomy
Patients randomized to cryoablation who experience disease recurrence may undergo crossover to lumpectomy.
Sponsors
Washington University School of Medicine
The Foundation for Barnes-Jewish Hospital
Varian Medical Systems
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The initial 20 participants will be enrolled to a safety lead-in arm receiving cryoablation. The next 100 participants will be randomized in a 1:1 manner to either cryoablation or lumpectomy. Patients initially treated with cryoablation who have evidence of residual or recurrent tumor on follow-up imaging will be crossed over to receive a rescue lumpectomy.
Eligibility
Sex/Gender
FEMALE
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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. * 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Lead-In: Number of treatment-related complications | Assessed from start of treatment through 30 days after cryoablation treatment (estimated to be 31 days) | 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. |
| Randomized Controlled Trial: Ipsilateral breast cancer recurrence (IBTR) in the treated breast. | At 5 years. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients who are free of serious treatment-related complications | Assessed from start of treatment through 30 days after cryoablation treatment (estimated to be 31 days) | 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. |
| Proportion of patients who demonstrate disease-free survival (DFS) | Through 5 years. | 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. |
| Overall survival (OS) | Through 5 years. | OS is defined from date of procedure to date of death or date of last follow up if none of the recurrence events occur. |
Countries
United States
Contacts
CONTACTHeather Garrett, M.D.
PRINCIPAL_INVESTIGATORHeather Garrett, M.D.
Washington University School of Medicine
Outcome results
None listed