Cryoablation vs Lumpectomy in T1 Breast Cancers
Recruiting · NCT05505643 · Interventional (participants receive a specific treatment) · Lead sponsor: Washington University School of Medicine
View the official record on ClinicalTrials.gov →Interventions studied
Endocare SlimLine CryoprobeLumpectomy
What this trial is about
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.
Who can take part
Age range
50 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed across 1 US state.
- Washington University School of Medicine - St Louis, Missouri, United States