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
Qualifiers
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
Treatments tested in this trial
- Endocare SlimLine Cryoprobe
- Lumpectomy
Treatment groups
120 Participants
are divided into 4 treatment groupsSponsors and collaborators
Washington University School of Medicine
Lead sponsor
The Foundation for Barnes-Jewish Hospital
Collaborator
Varian Medical Systems
Collaborator
Source ClinicalTrials.gov