Clinical trial NCT04334785: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2020-04-06
Enrollment: 186
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

stage 1:

1. female
2. ≥18 years old
3. 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).
4. lump can be detected by ultrasound.
5. image results (including ultrasound, mammography and MR image) prove the lump is single-center, the maximum diameter of the lump \<2cm.
6. with enough breast tissue, and enough space from lump to skin.
7. patients is not pregnant and has no plan for pregnancy in 2 years.
8. ECOG level: 0-2
9. serum creatinine≤1.1 mg/dl
10. for patients with double side (left and right side) breast cancer, both side of the tumor should meet the inclusion criteria.
11. patients are accessible for the follow up and mentally healthy.

stage 2:

1. female
2. ≥18 years old
3. 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).
4. lump can be detected by ultrasound.
5. image results (including ultrasound, mammography and MR image) prove the lump is single-center, the maximum diameter of the lump \<1.5cm.
6. with enough breast tissue, and enough space from lump to skin.
7. clinically N0 before cryo-ablation.
8. patients is not pregnant and has no plan for pregnancy in 2 years.
9. ECOG level: 0-2
10. serum creatinine≤1.1 mg/dl
11. for patients with double side (left and right side) breast cancer, both side of the tumor should meet the inclusion criteria.
12. patients are accessible for the follow up and mentally healthy.

Exclusion Criteria:

stage 1:

1. \< 18 years old
2. male
3. the same side breast of the lump have been treated by surgery or other physical treatment within 3months.
4. 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).
5. image results (including ultrasound, mammography and MR image) prove the lump is multi-center, the maximum diameter of the lump ≥2cm.
6. image results (including ultrasound, mammography) prove calcium region ≥ 5mm
7. 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.
8. before the endpoint, patients is treated by other local treatment.
9. ECOG Level \>2
10. serum creatinine\>1.1 mg/dl
11. patients are not accessible for the follow up and mentally unhealthy.
12. patients are pregnant or lactating, or have plan for pregnancy in 2 years.
13. other situations which make patients not suitable for the trail or cryo-ablation.

stage 2:

1. \< 18 years old
2. male
3. the same side breast of the lump have been treated by surgery or other physical treatment within 3months.
4. 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).
5. absolute contraindication for breast conserving surgery.
6. image results (including ultrasound, mammography and MR image) prove the lump is multi-center, the maximum diameter of the lump ≥1.5cm.
7. image results (including ultrasound, mammography) prove calcium region ≥ 5mm
8. 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.
9. NOT clinically N0 before cryo-ablation.
10. patients are treated after neoadjuvant chemotherapy or neoadjuvant endocrine therapy.
11. patients with advanced breast cancer or other type of cancers.
12. with BRCA1/2 mutation
13. before the endpoint, patients is treated by other local treatment.
14. ECOG Level \>2
15. serum creatinine\>1.1 mg/dl
16. can not finish the radiotherapy afterwards or with contraindication of radiotherapy
17. patients are not accessible for the follow up and mentally unhealthy.
18. patients are pregnant or lactating, or have plan for pregnancy in 2 years.
19. other situations which make patients not suitable for the trail or cryo-ablation.

Primary outcomes:
measure: Stage 1: Effectiveness of cryo-ablation
timeFrame: 1 month
measure: Stage 2: LRFS(local-regional free survival)
timeFrame: 5 years
measure: Stage 2: Effectiveness of cryo-ablation (3 months after cryo-ablation)
timeFrame: 3 month
Secondary outcomes:
measure: Stage 1: instant success rate
timeFrame: 3 minutes
measure: Stage 1: negative predictive value of ultrasound
timeFrame: 14 days and 28 days
measure: Stage 1: adverse events
timeFrame: 1 month
measure: Stage 2: instant success rate
timeFrame: 3 minutes
measure: Stage 2: shrinking rate
timeFrame: 5 years
measure: Stage 2: adverse events
timeFrame: 5 years
measure: Stage 2: breast self evaluation
timeFrame: 5 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
affiliation: Fudan University
name: Zhi-Min Shao
role: PRINCIPAL_INVESTIGATOR
References: