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

NCT04334785 | Unknown DMC FDA Device

• 1 other identifier: SCHBCC-N024
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (3)

• 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.

  1 month

• 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.

  5 years

• 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.

  3 month

Secondary Outcomes (7)

• Stage 1: instant success rate

  3 minutes

• Stage 1: negative predictive value of ultrasound

  14 days and 28 days

• Stage 1: adverse events

  1 month

• Stage 2: instant success rate

  3 minutes

• Stage 2: shrinking rate

  5 years

Study Arms (1)

cryo-ablation group

EXPERIMENTAL

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.

Device: cryo-ablation

Interventions

cryo-ablation DEVICE

Under the guide of ultrasound, cryo-ablation for the lump of early invasive breast cancer will be conducted.

cryo-ablation group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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).

You may not qualify if:

• 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:

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Zhi-Min Shao

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhi-Min Shao

CONTACT

086-021-64175590; zhimingshao@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: March 31, 2020
• First Posted: April 6, 2020
• Study Start: May 1, 2020
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: April 6, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)