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

Fudan University

Status: Enrolling

Conditions: Breast Cancer

Treatments: Device: cryo-ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT04334785

SCHBCC-N024

Details and patient eligibility

About

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.

Enrollment: 186 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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186 participants in 1 patient group

cryo-ablation group

Experimental group

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.

Treatment:

Device: cryo-ablation