To evaluate the efficacy of cryoablation without lumpectomy and its impact on local and distant recurrence of early stage breast cancer .
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
206
Ironwood Cancer & Research Centers
Glendale, Arizona, United States
BreastLink
Santa Ana, California, United States
Local Inbreast Breast Tumor Recurrence (IBTR) Rate
6 months post cryoabltion, then annually for 5 years
Time frame: up to 5 years
Complete Primary Tumor Ablation Rate
Complete ablation of primary tumor up to 60 months after cryoablation, reported as the percentage of patients with complete tumor ablation.
Time frame: up to 5 years from procedure date.
Improvement or Maintenance of Subject's Quality of Life
Quality of life will be assessed using the NCCN Distress Thermometer, a 0-10 scale measuring patient distress (0 = no distress, 10 = extreme distress; higher scores indicate worse distress), collected at baseline and at 6 months follow-up visit.
Time frame: Baseline and 6 months
Breast Cosmetics Satisfaction
Participants and treating physicians rated satisfaction with cosmetic outcomes following breast cryoablation.
Time frame: Up to 5 years following procedure
Regional Recurrence Rate
Regional Invasive breast tumor recurrence rate.
Time frame: up to 5 years following procedure
Distant Metastases Survival Rate
Distant metastases survival rate, including contralateral Breast cancer
Time frame: up to 5 years following procedure
Disease-free Survival (DFS)
DFS from the date of complete ablation of the primary tumor until the first disease event, where the disease event is defined as local (DCIS or invasive), regional, or distant breast cancer recurrence, or DCIS or invasive contralateral breast cancer.
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Bridgeport Hospital, Yale Medical School
Trumbull, Connecticut, United States
Dalton Surgical Group
Dalton, Georgia, United States
Indiana University
Indianapolis, Indiana, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Regional Medical Imaging
Flint, Michigan, United States
Comprehensive Breast Care
Troy, Michigan, United States
CentraState Medical Center
Freehold, New Jersey, United States
Breast Specialty care/ Presbyterian Hospital
Albuquerque, New Mexico, United States
...and 9 more locations
Time frame: up to 5 years
Overall Survival
Overall survival from the date of the cryoablation until the date of death from any cause or up to the 60 months follow up visit
Time frame: up to 5 years
Breast Cancer Survival.
Breast Cancer Survival from the date of cryoablation until the date of death from breast cancer or up to the 60 months follow-up visit.
Time frame: up to 5 years