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NCT Number: NCT07484087

Ablation Compare With Surgery for Early 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:

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.

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Key information

Conditions

Breast Cancer Ablation Breast Diseases Breast Neoplasms Early Stage Hormone Receptor Positive Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

50 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location status: Recruiting

Location contact

yuan peng, Dr

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

breast conserving surgery

Procedure

According to the 《Chinese Breast Cancer Diagnosis and Treatment Guidelines》, standard breast-conserving surgery (BCS) was performed, with pathologically confirmed negative margins.

cryo-thermal ablation

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. complication rate

    Time frame: 3 months

    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).

  2. Disease-Free Survival

    Time frame: 3 years

    Time from study enrollment to the first occurrence of:

    Ipsilateral locoregional recurrence. Contralateral breast cancer. Distant metastasis, Death from any cause.

  3. overall survival

    Time frame: 5 years

    Time from study enrollment to death from any cause.

  4. Quality of Life (QoL)

    Time frame: 1 year

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

yuan peng, doctor

CONTACT

[email protected]

86+13671287670

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Registry information

Official study title

Prospective, Randomized Controlled Study Comparing Cryo-Thermal Ablation With Traditional Breast-Conserving Surgery in HR-Positive, HER2-Negative Early-Stage Breast Cancer

Important dates

Study start
2026
Primary completion
2028
Study completion
2031
First posted
Mar 19, 2026
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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