Cryoablation Versus Lumpectomy in Early-Stage Breast Cancer
ConditionEarly-Stage Breast Cancer
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age60+
SponsorFranciscus Gasthuis & Vlietland (Hospital)
About this trial
The goal of this randomised controlled trial is to compare ipsilateral breast cancer recurrence rates in patients with early-stage breast cancer between patients treated with breast conserving surgery and patient treated with percutaneous cryo-ablation.
Eligibility criteria
Qualifiers
Women
Age > 60 years
Postmenopausal (no menstrual period for at least 12 months or in case of an intra-uterine device (IUD) hormone levels that indicate the menopause: follicle stimulating hormone (FSH) > 20 IE/l and estradiol < 100 pmol/l)
Histopathological confirmed primary invasive ER+/HER2- type breast cancer
Disqualifiers
History of invasive breast cancer
Breast augmentation
BRCA-1 or 2 gene mutation carrier
Lobular carcinoma
Trial design
Treatments tested in this trial
- Percutaneous cryoablation
- Breast-conserving surgery
Treatment groups
938 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov