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West Cancer Center
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BREAST: Primary Treatment; T<1.5cm; Age>65; ER/PR+ HER2-: \"Ice3\"

Cryoablation of low risk breast cancer less than 1.5 cm: An evaluation of local recurrence (Ice-3 trial)

Title
Icecure ICMBC-02
Study Title

Cryoablation of low risk breast cancer less than 1.5 cm: An evaluation of local recurrence (Ice-3 trial)

Site Link
NCT02200705
Malignancy
Breast cancer, early
Stage
Stage 1
Disease Setting
Primary treatment
Line Of Therapy
N/A
Investigational Agent
Ice-Sense3TM
Drug Class
Cryoablative device
PI
Richard Fine, MD, FACS
Sponsor
IceCure Medical
Phase
Phase 2
Status
Closed to Accrual
Key Eligibility Criteria
http://www.clinicaltrials.gov/ct2/show/NCT02200705
Key Eligibility Criteria Details

 

  • Age >65
  • Tumor size <1.5cm in greatest dimension
  • Unifocal Primary DiseaseInvasive Ductal Carcinoma
  • ER+, PR+ HER2-
  • Ki-67<14%
  • Nottingham Grade 1-2
  • No microinvasion or extensive intraductal component
  • No multi-focal calcifications
  • No prior or concurrent neoadjuvant therapy
  • No en bloc open biopsy or lumpectomy on tissue specimen
Objective

Primary- local in-breast tumor recurrence: Secondary: complete ablation up to 5yr, QOL, cosmetic satisfaction, regional and distant DFS, OS

Assessment Frequency
_
Assessment Frequency 2
_



Assessment Frequency Link
Path
Invasive ductal carcinomaER positivePR positiveHER2 negativeKi-67 <14%
Dosing Frequency

Once

Control Agents
N/A
Study Protocol
Randomized
No
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