Breast CancerNCT07484087
Ablation Compare With Surgery for Early Breast Cancer
A study testing breast conserving surgery and cryo-thermal ablation in people with Breast Cancer and Early Stage, run by Peking University People's Hospital at 1 site in China.
Trial summary
Breast-conserving surgery has been widely used in clinical practice, but surgical incisions still impact postoperative patient satisfaction with breast appearance. The development of tumor ablation technologies has introduced new possibilities for breast cancer surgical treatment. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Breast Cancer, Early Stage, Hormone Receptor Positive
- What is being tested?
- breast conserving surgery and cryo-thermal ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 31 Dec 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Age ≥50 Years 2.Unifocal disease (single tumor) confirmed by ultrasound, MRI, or mammography. Ultrasound visibility: Essential for precise intraoperative ablation targeting. 3.Pathologically Confirmed Invasive Ductal Carcinoma (IDC)。Diagnostic Method: Core needle biopsy (CNB) confirming IDC.
- 4.Histologic Grade: G1 or G2; ER/PR-positive and HER2-negative. 5.TNM stage: IA. Tumor Size: ≤2 cm; Lymph Node Status: Clinically \& radiologically negative (no palpable/imaging-detected axillary involvement).
- 6.Written consent for clinical trial participation and acceptance of random assignment
Who cannot join
- 1.Extensive intraductal component (EIC) suggested by imaging or pathology. 2.Invasion of adjacent skin or muscle. 3.Prior anticancer treatment for the current disease, including but not limited to chemotherapy, endocrine therapy, targeted therapy, or immunotherapy. 5.Refusal to undergo breast-conserving surgery. 6.Pregnancy or lactation. 7.Previous radiotherapy to the affected breast or other contraindications to radiotherapy. 8.Concurrent untreated malignancies or severe systemic diseases， 9.Known allergy, intolerance, or contraindications to cryotherapy (e.g., cryoglobulinemia, implanted electronic devices). 10.Inability to comply with follow-up or refusal of adjuvant therapy. 11.Vulnerable populations, including individuals with neurological disorders, cognitive impairment, or critical illness.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
yuan peng, Dr
About this study
Official title: Prospective, Randomized Controlled Study Comparing Cryo-Thermal Ablation With Traditional Breast-Conserving Surgery in HR-Positive, HER2-Negative Early-Stage Breast Cancer
Breast-conserving surgery has been widely used in clinical practice, but surgical incisions still impact postoperative patient satisfaction with breast appearance. The development of tumor ablation technologies has introduced new possibilities for breast cancer surgical treatment. The hybrid cryo-thermal ablation system, an advanced minimally invasive tumor treatment device independently developed in China, employs a combined approach of deep cryoablation and high-intensity heating for therapy and has been approved for treating solid tumors, including breast cancer.
This study is a prospective, single-center, randomized controlled trial. Eligible patients with newly diagnosed early-stage breast cancer treated at the Breast Center of Peking University People's Hospital will be enrolled and randomized in a 1:1 ratio to receive either hybrid cryo-thermal ablation (experimental group) or breast-conserving surgery (control group). Data collected will include:
Read more
Baseline clinicopathological characteristics， Surgical details (operation time, intraoperative/postoperative complications, etc.)， Peripheral blood lymphocyte distribution， Treatment efficacy (ipsilateral breast tumor recurrence rate, disease-free survival, overall survival)， Aesthetic outcomes (BREAST-Q score).
Primary endpoint:
Ipsilateral breast local recurrence rate，
Secondary endpoints:
Safety (incidence of adverse events assessed by CTCAE criteria)， Disease-free survival and overall survival， Quality of life assessment (breast satisfaction)，
Exploratory endpoints:
Pathological response of ablated tumor tissue， Correlation analysis between postoperative imaging (MRI/ultrasound) features and recurrence risk.
- Conditions
- Breast Cancer, Early Stage, Hormone Receptor Positive, Ablation
- Being tested
- breast conserving surgery, cryo-thermal 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.
breast conserving surgeryProcedure or surgery
According to the 《Chinese Breast Cancer Diagnosis and Treatment Guidelines》, standard breast-conserving surgery (BCS) was performed, with pathologically confirmed negative margins.
cryo-thermal ablationProcedure or surgery
Real-time ultrasound imaging to confirm tumor size and shape. Mark the ablation target zone, including the 5-mm peripheral margin. Ablation Procedure Step 1: Probe Insertion Under ultrasound guidance, insert the cryo-thermal ablation probe into the tumor center.
Step 2: Dual-Cycle Ablation (Freeze-Heating-Freeze)
First Freeze Cycle:
Duration: 10-15 minutes. Temperature: Rapid cooling to -196°C (liquid nitrogen). Endpoint: Ice ball fully envelops the tumor + 5-mm margin (confirmed by ultrasound).
Heating Phase:
Temperature: Rapid heating to 80°C. Duration: 5-10 minutes (thawing and thermal damage enhancement).
Second Freeze Cycle:
Repeat freezing to ensure complete tumor destruction.
| Study group | Role | What they receive |
|---|---|---|
| breast conserving surgery | Experimental | According to the 《Chinese Breast Cancer Diagnosis and Treatment Guidelines》, standard breast-conserving surgery (BCS) was performed, with pathologically confirmed negative margins. Receives: Procedure: breast conserving surgery |
| cryo-thermal ablation | Experimental | Under ultrasound guidance, the tumor location and boundaries were precisely marked to ensure the ablation zone covered at least 5 mm beyond the tumor edge, achieving complete oncological safety. Receives: Procedure: cryo-thermal ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ipsilateral Breast Tumor Recurrence Rate
The time from the date of surgery to the date of ipsilateral breast tumor recurrence, with the occurrence of ipsilateral breast tumor recurrence as the event.
Measured: 3 years
Secondary outcomes (4)
complication rate
intraoperative Complications: Bleeding, vascular/nerve injury.
Postoperative Complications:
Infection, hematoma, skin frostbite (cryoablation-specific), breast deformity, sensory abnormalities.
Grading: Recorded per CTCAE v5.0 (e.g., Grade 1: mild; Grade 3: severe requiring intervention).
Measured: 3 months
Disease-Free Survival
Time from study enrollment to the first occurrence of:
Ipsilateral locoregional recurrence. Contralateral breast cancer. Distant metastasis, Death from any cause.
Measured: 3 years
overall survival
Time from study enrollment to death from any cause.
Measured: 5 years
Quality of Life (QoL)
Tool: BREAST-Q (validated patient-reported outcome measure) Phychosocial well-being scale, satisfaction with breasts scale
Domains Evaluated:
Breast aesthetics (appearance/satisfaction post-treatment). Psychosocial/sexual well-being. Physical discomfort.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start1 Jan 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2031 (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 Peking University People's HospitalThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shu Wang, Peking University People's Hospital
- Investigators
- shu wang, doctor, Study director, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07484087
- Sponsor's protocol ID
- PKUPHAblation
- Status last verified
- Mar 2026
- First submitted
- 3 Mar 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized Controlled Study Comparing Cryo-Thermal Ablation With Traditional Breast-Conserving Surgery in HR-Positive, HER2-Negative Early-Stage Breast Cancer
- ClinicalTrials.gov ID
- NCT07484087
- Acronym / sponsor ID
- PKUPHAblation
- Conditions
- Breast Cancer, Early Stage, Hormone Receptor Positive, Ablation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 19 Mar 2026 (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.
Breast-conserving surgery has been widely used in clinical practice, but surgical incisions still impact postoperative patient satisfaction with breast appearance. The development of tumor ablation technologies has introduced new possibilities for breast cancer surgical treatment. The hybrid cryo-thermal ablation system, an advanced minimally invasive tumor treatment device independently developed in China, employs a combined approach of deep cryoablation and high-intensity heating for therapy and has been approved for treating solid tumors, including breast cancer.
This study is a prospective, single-center, randomized controlled trial. Eligible patients with newly diagnosed early-stage breast cancer treated at the Breast Center of Peking University People's Hospital will be enrolled and randomized in a 1:1 ratio to receive either hybrid cryo-thermal ablation (experimental group) or breast-conserving surgery (control group). Data collected will include:
Baseline clinicopathological characteristics， Surgical details (operation time, intraoperative/postoperative complications, etc.)， Peripheral blood lymphocyte distribution， Treatment efficacy (ipsilateral breast tumor recurrence rate, disease-free survival, overall survival)， Aesthetic outcomes (BREAST-Q score).
Primary endpoint:
Ipsilateral breast local recurrence rate，
Secondary endpoints:
Safety (incidence of adverse events assessed by CTCAE criteria)， Disease-free survival and overall survival， Quality of life assessment (breast satisfaction)，
Exploratory endpoints:
Pathological response of ablated tumor tissue， Correlation analysis between postoperative imaging (MRI/ultrasound) features and recurrence risk.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| breast conserving surgery | Experimental | Procedure: breast conserving surgeryAccording to the 《Chinese Breast Cancer Diagnosis and Treatment Guidelines》, standard breast-conserving surgery (BCS) was performed, with pathologically confirmed negative margins. |
| cryo-thermal ablation | Experimental | Procedure: cryo-thermal ablationUnder ultrasound guidance, the tumor location and boundaries were precisely marked to ensure the ablation zone covered at least 5 mm beyond the tumor edge, achieving complete oncological safety. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1.Age ≥50 Years 2.Unifocal disease (single tumor) confirmed by ultrasound, MRI, or mammography. Ultrasound visibility: Essential for precise intraoperative ablation targeting. 3.Pathologically Confirmed Invasive Ductal Carcinoma (IDC)。Diagnostic Method: Core needle biopsy (CNB) confirming IDC.
- 4.Histologic Grade: G1 or G2; ER/PR-positive and HER2-negative. 5.TNM stage: IA. Tumor Size: ≤2 cm; Lymph Node Status: Clinically \& radiologically negative (no palpable/imaging-detected axillary involvement).
- 6.Written consent for clinical trial participation and acceptance of random assignment
Key exclusion criteria (1 listed)
- 1.Extensive intraductal component (EIC) suggested by imaging or pathology. 2.Invasion of adjacent skin or muscle. 3.Prior anticancer treatment for the current disease, including but not limited to chemotherapy, endocrine therapy, targeted therapy, or immunotherapy. 5.Refusal to undergo breast-conserving surgery. 6.Pregnancy or lactation. 7.Previous radiotherapy to the affected breast or other contraindications to radiotherapy. 8.Concurrent untreated malignancies or severe systemic diseases， 9.Known allergy, intolerance, or contraindications to cryotherapy (e.g., cryoglobulinemia, implanted electronic devices). 10.Inability to comply with follow-up or refusal of adjuvant therapy. 11.Vulnerable populations, including individuals with neurological disorders, cognitive impairment, or critical illness.
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 |
|---|---|---|
| breast conserving surgeryAccording to the 《Chinese Breast Cancer Diagnosis and Treatment Guidelines》, standard breast-conserving surgery (BCS) was performed, with pathologically confirmed negative margins. | Procedure or surgery | breast conserving surgery |
| cryo-thermal ablationReal-time ultrasound imaging to confirm tumor size and shape. Mark the ablation target zone, including the 5-mm peripheral margin. Ablation Procedure Step 1: Probe Insertion Under ultrasound guidance, insert the cryo-thermal ablation probe into the tumor center. Step 2: Dual-Cycle Ablation (Freeze-Heating-Freeze) First Freeze Cycle: Duration: 10-15 minutes. Temperature: Rapid cooling to -196°C (liquid nitrogen). Endpoint: Ice ball fully envelops the tumor + 5-mm margin (confirmed by ultrasound). Heating Phase: Temperature: Rapid heating to 80°C. Duration: 5-10 minutes (thawing and thermal damage enhancement). Second Freeze Cycle: Repeat freezing to ensure complete tumor destruction. | Procedure or surgery | cryo-thermal ablation |
Primary outcome
Ipsilateral Breast Tumor Recurrence Rate
Time frame: 3 years
The time from the date of surgery to the date of ipsilateral breast tumor recurrence, with the occurrence of ipsilateral breast tumor recurrence as the event.
4 secondary outcomes
complication rate
Time frame: 3 months
Disease-Free Survival
Time frame: 3 years
overall survival
Time frame: 5 years
Quality of Life (QoL)
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
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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.
shu wang, doctor study director
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing breast conserving surgery and cryo-thermal ablation in people with Breast Cancer and Early Stage, run by Peking University People's Hospital 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 3 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 19 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact yuan peng, doctor (86+13671287670, 13671287670@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ipsilateral Breast Tumor Recurrence Rate (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Mar 2026.