Cryoablation vs Lumpectomy in T1 Breast Cancers
COOL-IT: Cryoablation vs Lumpectomy in T1 Breast Cancers: A Randomized Controlled Trial With Safety Lead-in
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 50 Years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests how safe and effective freezing a breast tumor is compared with lumpectomy, surgery to remove the tumor. It is for people age 50 or older with low-risk, early-stage breast cancer. Researchers will compare cancer control, health problems after treatment, and quality of life.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Age 50 or older.
- Have invasive ductal breast cancer, which starts in a milk duct and grows into nearby tissue. It must be HER2-negative and grade 1 or 2, meaning the cells look less abnormal under a microscope.
- The tumor must be 2 cm or smaller and must not have spread to lymph nodes or other parts of the body.
- Any DCIS, cancer that stays inside the milk ducts, must make up less than 25% of the tumor. It must connect to the invasive cancer, not be a separate tumor.
- For certain tumor sizes and hormone test results, an Oncotype tumor gene test is required. The score must be below 26.
- An ultrasound or tissue test must show no cancer in the armpit lymph nodes on the same side. There must be no other signs that cancer has spread to these nodes.
- Able to understand the study and willing to sign a written consent form.
Who can't join
- Need chemotherapy before treatment to remove or destroy the tumor.
- Have had breast cancer before.
- Have had breast enlargement surgery.
- Are allergic to medicines used to numb an area.
- Are pregnant or breastfeeding. Those who could become pregnant must have a negative pregnancy test within 14 days before joining.
- The tumor has grown into the skin or chest wall.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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.
Study sites (1)
MO
- Washington University School of Medicine · St Louis, MO 63110Heather Garrett, M.D. · Study contact · 636-916-9662 · hvgarrett@wustl.eduHeather Garrett, M.D. · Principal investigatorRobert McKinstry, M.D. · Sub-investigatorDebbie Bennett, M.D. · Sub-investigatorMore trials in St Louis