Breast carcinoma, mammary carcinoma, malignant breast tumor, breast malignancy, carcinoma of the breast Breast cancer
Conditions
Interventions
The intervention under study is breast tumor cryoablation. Under ultrasound guidance, a thin cryoprobe is inserted into the tumor. Through this probe, argon or nitrogen gas is circulated, creating ext
Sponsors
Antonius Ziekenhuis
Eligibility
Age
65 Years to 99 Years
Inclusion criteria
Inclusion criteria: Age = 70 yearsHistologically confirmed invasive breast cancerClinical stage cT1N0M0 based on mammography and ultrasoundER-positive, HER2-negative (IHC 0-1+ or 2+ with negative ISH), any PR statusPresence of concurrent DCIS is allowed if limited to <25% of the pre-NST biopsy, with no radiologic suspicion of an extensive componentUnifocal disease <2 cm, well visualized on ultrasound, with a minimum distance of =5 mm from the skin, nipple and thoracic wallAbility and willingness to comply with project requirementsPreoperative endocrine therapy is allowedWritten informed consent given by the subject
Exclusion criteria
Exclusion criteria: Pure DCIS lesions without invasive componentExtensive calcifications on imaging suggestive of widespread diseaseInvasive lobular carcinoma (as assessed by IHC)Triple-negative or HER2-positive subtype (defined as (IHC 3+ or ISH positive)History of ipsilateral breast cancer or DCISPrior ipsilateral radiotherapyInability to communicate in Dutch or English languagePlanned (e)migration or long-term stay abroad within one year after inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure is the safety and feasibility of cryoablation in this patient population. This will be assessed by:incidence and type of adverse events and complications up to 3 months post-procedure, classified according to CTCAE v5.0;technical success and procedural feasibility (complete treatment of the tumor, procedure performed as planned).Secondary outcomes include recovery, cosmetic outcomes, quality of life, and patient satisfaction. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes include recovery, cosmetic outcomes, quality of life, and patient satisfaction. | — |
Countries
Netherlands
Contacts
Public ContactI Stekelenburg
Antonius Ziekenhuis
Outcome results
None listed