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

A study testing cryo-ablation in people with Breast Cancer, run by Fudan University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Breast Cancer
What is being tested?: cryo-ablation
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 186 participants
Where: 1 siteChina
Study dates: 1 May 2020to 1 May 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

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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.

Who cannot join

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.

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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.

Trial locations and contacts

1 site in 1 country.

Zhi-Min Shao contact

086-021-64175590

zhimingshao@yahoo.com

China1 site, 1 recruiting

Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Zhimin Shao, +86-021-64175590
Recruiting

Other trials in China

About this study

Conditions: Breast Cancer
Being tested: cryo-ablation
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04334785
Study group	Role	What they receive
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. Receives: Device: cryo-ablation

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 3 month

Secondary outcomes (7)

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.
Measured: 3 minutes
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
Measured: 14 days and 28 days
Stage 1: adverse events
Short-term safety of cryo-ablation after the treatment
Measured: 1 month
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.
Measured: 3 minutes
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.
Measured: 5 years
Stage 2: adverse events
Short-term and long-term safety of cryo-ablation after the treatment
Measured: 5 years
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.
Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 20201 May 2025

First posted6 Apr 2020
Study start1 May 2020 (estimated)
Primary completion1 May 2025 (estimated)
Study completion1 May 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Breast CancerStudies of the same condition, open and under way.
More trials run by Fudan UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 186 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04334785
Sponsor's protocol ID: SCHBCC-N024
Status last verified: Apr 2020
First submitted: 31 Mar 2020
Last updated: 6 Apr 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

Zhi-Min Shao

086-021-64175590

zhimingshao@yahoo.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation for the Effectiveness and Safety of Cryo-ablation in the Treatment of Early Invasive Breast Cancer
ClinicalTrials.gov ID: NCT04334785
Acronym / sponsor ID: SCHBCC-N024
Conditions: Breast Cancer
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 186 participants (estimated)
Lead sponsor: Fudan UniversityUniversity, hospital or other
Study start: 1 May 2020 (estimated)
Primary completion: 1 May 2025 (estimated)
Study completion: 1 May 2025 (estimated)
First posted: 6 Apr 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
cryo-ablation group	Experimental	Device: cryo-ablationIn 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.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (25 listed)

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.

Key exclusion criteria (34 listed)

< 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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
cryo-ablationUnder the guide of ultrasound, cryo-ablation for the lump of early invasive breast cancer will be conducted.	Device	cryo-ablation group

Primary outcome

Stage 1: Effectiveness of cryo-ablation
Time frame: 1 month
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)
Time frame: 5 years
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)
Time frame: 3 month
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.

7 secondary outcomes

Stage 1: instant success rate
Time frame: 3 minutes
Stage 1: negative predictive value of ultrasound
Time frame: 14 days and 28 days
Stage 1: adverse events
Time frame: 1 month
Stage 2: instant success rate
Time frame: 3 minutes
Stage 2: shrinking rate
Time frame: 5 years
Stage 2: adverse events
Time frame: 5 years
Stage 2: breast self evaluation
Time frame: 5 years

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2020.
Individual participant dataSharing planned: No

Related trials for Breast Cancer

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Zhi-Min Shao contact

086-021-64175590

zhimingshao@yahoo.com

Zhi-Min Shao principal investigator

Fudan University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing cryo-ablation in people with Breast Cancer, run by Fudan University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Zhi-Min Shao (086-021-64175590, zhimingshao@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stage 1: Effectiveness of cryo-ablation (time frame: 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04334785.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2020.