Evaluation for the Effectiveness and Safety of Cryo-ablation in the Treatment of Early Invasive Breast Cancer

  • STATUS
    Recruiting
  • End date
    May 1, 2025
  • participants needed
    186
  • sponsor
    Fudan University
Updated on 3 March 2022
carcinoma
HER2
erbb2
invasive breast cancer
breast cancer staging
mammogram
ductal carcinoma
core needle biopsy
early-stage breast cancer
ki-67

Summary

Recently, researchers in America reported a clinical research (Alliance Z1072) which proved that cryo-ablation could be considered as a non-surgical treatment of early-stage breast cancer. The long term effectiveness and safety of cryo-ablation in early invasive breast cancer is still unknown. Therefore, this prospective study are designed to evaluate the effectiveness and safety of cryo-ablation in early invasive breast cancer.

Details
Condition Breast Cancer
Treatment cryo-ablation
Clinical Study IdentifierNCT04334785
SponsorFudan University
Last Modified on3 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

stage 1
female
18 years old
invasive ductal carcinoma proved by core needle biopsy. Other type of breast cancer should be well considered and decided by investigators. Pathological report should be complete (with the result of ER, PR , HER2, KI67 etc., and FISH report of ERBB2 gene if necessary)
lump can be detected by ultrasound
image results (including ultrasound, mammography and MR image) prove the lump is single-center, the maximum diameter of the lump <2cm
with enough breast tissue, and enough space from lump to skin
patients is not pregnant and has no plan for pregnancy in 2 years
ECOG level: 0-2
serum creatinine1.1 mg/dl
for patients with double side (left and right side) breast cancer, both side of the tumor should meet the inclusion criteria
patients are accessible for the follow up and mentally healthy
stage 2
female
18 years old
invasive ductal carcinoma proved by core needle biopsy. Other type of breast cancer should be well considered and decided by investigators. Pathological report should be complete (with the result of ER, PR , HER2, KI67 etc., and FISH report of ERBB2 gene if necessary)
lump can be detected by ultrasound
image results (including ultrasound, mammography and MR image) prove the lump is single-center, the maximum diameter of the lump <1.5cm
with enough breast tissue, and enough space from lump to skin
clinically N0 before cryo-ablation
patients is not pregnant and has no plan for pregnancy in 2 years
ECOG level: 0-2
serum creatinine1.1 mg/dl
for patients with double side (left and right side) breast cancer, both side of the tumor should meet the inclusion criteria
patients are accessible for the follow up and mentally healthy

Exclusion Criteria

stage 1
< 18 years old
male
the same side breast of the lump have been treated by surgery or other physical treatment within 3months
benign tumor or tumor in situ or tumor in situ with micro-invasion proved by core needle biopsy. Pathological report is not complete (with the result of ER, PR , HER2, KI67 etc., and FISH report of ERBB2 gene if necessary)
image results (including ultrasound, mammography and MR image) prove the lump is multi-center, the maximum diameter of the lump 2cm
image results (including ultrasound, mammography) prove calcium region 5mm
lump can not be clearly detected by ultrasound. For example, the boundary of tumor is not clear, or the maximum diameter detected by MRI is more than 1.5 times larger than the maximum diameter detected by ultrasound
before the endpoint, patients is treated by other local treatment
ECOG Level >2
serum creatinine>1.1 mg/dl
patients are not accessible for the follow up and mentally unhealthy
patients are pregnant or lactating, or have plan for pregnancy in 2 years
other situations which make patients not suitable for the trail or cryo-ablation
stage 2
< 18 years old
male
the same side breast of the lump have been treated by surgery or other physical treatment within 3months
benign tumor or tumor in situ or tumor in situ with micro-invasion proved by core needle biopsy. Pathological report is not complete (with the result of ER, PR , HER2, KI67 etc., and FISH report of ERBB2 gene if necessary)
absolute contraindication for breast conserving surgery
image results (including ultrasound, mammography and MR image) prove the lump is multi-center, the maximum diameter of the lump 1.5cm
image results (including ultrasound, mammography) prove calcium region 5mm
lump can not be clearly detected by ultrasound. For example, the boundary of tumor is not clear, or the maximum diameter detected by MRI is more than 1.5 times larger than the maximum diameter detected by ultrasound
NOT clinically N0 before cryo-ablation
patients are treated after neoadjuvant chemotherapy or neoadjuvant endocrine therapy
patients with advanced breast cancer or other type of cancers
with BRCA1/2 mutation
before the endpoint, patients is treated by other local treatment
ECOG Level >2
serum creatinine>1.1 mg/dl
can not finish the radiotherapy afterwards or with contraindication of radiotherapy
patients are not accessible for the follow up and mentally unhealthy
patients are pregnant or lactating, or have plan for pregnancy in 2 years
other situations which make patients not suitable for the trail or cryo-ablation
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