Ablation versus breast-conserving surgery for early hormone receptor–positive breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-center, randomized controlled trial at Peking University People's Hospital that will randomize eligible patients 1:1 to receive hybrid cryo-thermal ablation or standard breast-conserving surgery. Eligible patients are women aged 50 or older with a unifocal invasive ductal carcinoma ≤2 cm, grade 1–2, ER/PR-positive and HER2-negative, and clinically node-negative. The hybrid device combines deep cryoablation and high-intensity heating and is applied under imaging guidance for ultrasound-visible tumors. Clinical and clinicopathological data will be collected to compare outcomes between the two groups.

Why it matters

Who can join: the full rules

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.

Where it's running

• Peking University People's Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: yuan peng, doctor
• Email: 13671287670@163.com
• Phone: 86+13671287670

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.