Back to resultsEvaluation for the Effectiveness and Safety of Cryo-ablation in the Treatment of Early Invasive Breast Cancer
Primary Purpose
Breast Cancer
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
cryo-ablation
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
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 creatinine≤1.1 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 creatinine≤1.1 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.
Sites / Locations
- Fudan University Shanghai Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
cryo-ablation group
Arm Description
In the first stage, for patients who meet the criteria, cryo-ablation will be conducted for the lump of invasive breast cancer, and traditional surgery will be conducted within 32days after cryo-surgery. In the second stage, for patients who meet the criteria, cryo-ablation will be conducted, and 5-year effectiveness and safety will be evaluated subsequently.
Outcomes
Primary Outcome Measures
Stage 1: Effectiveness of cryo-ablation
In the first stage, patients will receive traditional surgery 1month after the cryo-ablation. After the traditional surgery (mastectomy or breast conserving surgery), the pathological report will show whether there is tumor tissue left in the breast tissue. If there is no tumor left in breast, cryo-ablation is effective in eliminating the tumor. Otherwise, cryo-ablation is ineffective.
Stage 2: LRFS(local-regional free survival)
In the second stage, 5-year local-regional free survival will be evaluated for patients with the treatment of cryo-ablation and traditional surgery is spared.
Stage 2: Effectiveness of cryo-ablation (3 months after cryo-ablation)
In the second stage, patients will receive muti-point core needle biopsy (which collect multi-point tissue from the region which was once the tumor region, as reported by MRI or ultrasound) 3months after the cryo-ablation. After the multi-point core needle biopsy, the pathological report will show whether there there is tumor tissue left in the breast tissue. If there is no tumor left in breast, cryo-ablation is effective in eliminating the tumor. Otherwise, cryo-ablation is ineffective.
Secondary Outcome Measures
Stage 1: instant success rate
Instant success rate will be evaluated instantly by the surgeon after the cryo-ablation, by his/her own judgement and ultrasound image.
Stage 1: negative predictive value of ultrasound
In the first stage, ultrasound will be conducted twice on day 14 and day 28 after the cryo-ablation (16 or 2 days before the traditional surgery). Negative predictive value of ultrasound will be calculated according to the pathological report after the traditional surgery in day 30. Negative predictive value = number of the patients who is pathologically negative AND ultrasound-negative/ number of patients who is ultrasound-negative
Stage 1: adverse events
Short-term safety of cryo-ablation after the treatment
Stage 2: instant success rate
Instant success rate will be evaluated instantly by the surgeon after the cryo-ablation, by his/her own judgement and ultrasound image.
Stage 2: shrinking rate
Comparing with the baseline tumor size, shrinking rate of the lump will be calculated in 3 months, 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, 5 years after cryo-ablation. The size of the lump will be evaluated by MR image.
Stage 2: adverse events
Short-term and long-term safety of cryo-ablation after the treatment
Stage 2: breast self evaluation
breast self evaluation for patients with cryo-ablation and for whom traditional surgery is spared, as assessed by BREAST Q© index. The BREAST-Q has a modular, procedure-specific structure with scales that evaluate both satisfaction and quality of life. Psychometric evaluation reveals high reliability, validity and responsiveness to surgical intervention across all scales. Breast Q is composed of aesthetical and emotional modules, and each score ranges from 1 to 4 points (higher values represent a better self evaluation). By comparing the sum of the score in different modules before and after the surgery, Breast Q can help to facilitate a self evaluation for breast cancer patients.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04334785
Brief Title
Evaluation for the Effectiveness and Safety of Cryo-ablation in the Treatment of Early Invasive Breast Cancer
Official Title
Evaluation for the Effectiveness and Safety of Cryo-ablation in the Treatment of Early Invasive Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2020 (Anticipated)
Primary Completion Date
May 1, 2025 (Anticipated)
Study Completion Date
May 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
186 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
cryo-ablation group
Arm Type
Experimental
Arm Description
In the first stage, for patients who meet the criteria, cryo-ablation will be conducted for the lump of invasive breast cancer, and traditional surgery will be conducted within 32days after cryo-surgery. In the second stage, for patients who meet the criteria, cryo-ablation will be conducted, and 5-year effectiveness and safety will be evaluated subsequently.
Intervention Type
Device
Intervention Name(s)
cryo-ablation
Intervention Description
Under the guide of ultrasound, cryo-ablation for the lump of early invasive breast cancer will be conducted.
Primary Outcome Measure Information:
Title
Stage 1: Effectiveness of cryo-ablation
Description
In the first stage, patients will receive traditional surgery 1month after the cryo-ablation. After the traditional surgery (mastectomy or breast conserving surgery), the pathological report will show whether there is tumor tissue left in the breast tissue. If there is no tumor left in breast, cryo-ablation is effective in eliminating the tumor. Otherwise, cryo-ablation is ineffective.
Time Frame
1 month
Title
Stage 2: LRFS(local-regional free survival)
Description
In the second stage, 5-year local-regional free survival will be evaluated for patients with the treatment of cryo-ablation and traditional surgery is spared.
Time Frame
5 years
Title
Stage 2: Effectiveness of cryo-ablation (3 months after cryo-ablation)
Description
In the second stage, patients will receive muti-point core needle biopsy (which collect multi-point tissue from the region which was once the tumor region, as reported by MRI or ultrasound) 3months after the cryo-ablation. After the multi-point core needle biopsy, the pathological report will show whether there there is tumor tissue left in the breast tissue. If there is no tumor left in breast, cryo-ablation is effective in eliminating the tumor. Otherwise, cryo-ablation is ineffective.
Time Frame
3 month
Secondary Outcome Measure Information:
Title
Stage 1: instant success rate
Description
Instant success rate will be evaluated instantly by the surgeon after the cryo-ablation, by his/her own judgement and ultrasound image.
Time Frame
3 minutes
Title
Stage 1: negative predictive value of ultrasound
Description
In the first stage, ultrasound will be conducted twice on day 14 and day 28 after the cryo-ablation (16 or 2 days before the traditional surgery). Negative predictive value of ultrasound will be calculated according to the pathological report after the traditional surgery in day 30. Negative predictive value = number of the patients who is pathologically negative AND ultrasound-negative/ number of patients who is ultrasound-negative
Time Frame
14 days and 28 days
Title
Stage 1: adverse events
Description
Short-term safety of cryo-ablation after the treatment
Time Frame
1 month
Title
Stage 2: instant success rate
Description
Instant success rate will be evaluated instantly by the surgeon after the cryo-ablation, by his/her own judgement and ultrasound image.
Time Frame
3 minutes
Title
Stage 2: shrinking rate
Description
Comparing with the baseline tumor size, shrinking rate of the lump will be calculated in 3 months, 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, 5 years after cryo-ablation. The size of the lump will be evaluated by MR image.
Time Frame
5 years
Title
Stage 2: adverse events
Description
Short-term and long-term safety of cryo-ablation after the treatment
Time Frame
5 years
Title
Stage 2: breast self evaluation
Description
breast self evaluation for patients with cryo-ablation and for whom traditional surgery is spared, as assessed by BREAST Q© index. The BREAST-Q has a modular, procedure-specific structure with scales that evaluate both satisfaction and quality of life. Psychometric evaluation reveals high reliability, validity and responsiveness to surgical intervention across all scales. Breast Q is composed of aesthetical and emotional modules, and each score ranges from 1 to 4 points (higher values represent a better self evaluation). By comparing the sum of the score in different modules before and after the surgery, Breast Q can help to facilitate a self evaluation for breast cancer patients.
Time Frame
5 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 creatinine≤1.1 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 creatinine≤1.1 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhi-Min Shao
Phone
086-021-64175590
Email
zhimingshao@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhi-Min Shao
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhimin Shao
Phone
+86-021-64175590
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation for the Effectiveness and Safety of Cryo-ablation in the Treatment of Early Invasive Breast Cancer
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