An interventional study of breast conserving surgery and cryo-thermal ablation in Breast Cancer, Early Stage and Hormone Receptor Positive, sponsored by Peking University People's Hospital. Recruiting at 1 site in China. Open to female participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-03-19.
Sponsored by Peking University People's Hospital · Not applicable, Interventional, and Treatment
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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This study's planned enrollment of 264 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
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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:
According to the 《Chinese Breast Cancer Diagnosis and Treatment Guidelines》, standard breast-conserving surgery (BCS) was performed, with pathologically confirmed negative margins.
Procedure: breast conserving surgery
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.
Procedure: cryo-thermal ablation
According to the 《Chinese Breast Cancer Diagnosis and Treatment Guidelines》, standard breast-conserving surgery (BCS) was performed, with pathologically confirmed negative margins.
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.
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.
Time frame: 3 years
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).
Time frame: 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.
Time frame: 3 years
overall survival
Time from study enrollment to death from any cause.
Time frame: 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.
Time frame: 1 year
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