Ablation Compare With Surgery for Early Breast Cancer
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek 50 lat lub więcej
- •Jeden guz potwierdzony badaniem ultrasonograficznym, MRI lub mammografią
- •Potwierdzony histopatologicznie rak przewodowy (IDC)
- •Stopień złośliwości G1 lub G2, hormono-dodatni, HER2-ujemny
- •Stadium TNM IA (guz do 2 cm, węzły chłonne bez zmian)
- •Pisemna zgoda na udział w badaniu i akceptacja losowego przydziału do grupy
✗ Disqualifies
- •Rozległy składnik przewodowy widoczny w badaniu obrazowym lub potwierdzony mikroskopowo
- •Naciek skóry lub mięśni
- •Poprzednia chemioterapia, hormonoterapia lub inne leczenie przeciwnowotworowe
- •Odmowa poddania się operacji oszczędzającej pierś
- •Ciąża lub karmienie piersią
- •Poprzednia radioterapia piersi lub inne przeciwwskazania do radioterapii
- •Inne nielechone nowotwory lub poważne choroby ogólnoustrojowe
- •Uczulenie lub nieprawidłowa tolerancja krioterapii
Simplified criteria — AI translation
Trial details
- Minimum age
- 50 Years
- Last updated (source)
- March 19, 2026
- Sex
- Female only
Therapies / drugs in trial
Locations (1)
Peking University People's Hospital
Beijing, China
Trial contact
yuan peng, doctor
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.
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