Ablation versus breast-conserving surgery for early hormone receptor–positive breast cancer
Prospective, Randomized Controlled Study Comparing Cryo-Thermal Ablation With Traditional Breast-Conserving Surgery in HR-Positive, HER2-Negative Early-Stage Breast Cancer
This trial will test whether a minimally invasive hybrid cryo-thermal ablation works as well as breast-conserving surgery for women aged 50 and older with a single, small ER/PR-positive, HER2-negative early breast cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 264 (estimated) |
| Ages | 50 Years and up |
| Sex | Female |
| Sponsor | Peking University People's Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT07484087 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women aged 50 or older with a single, ultrasound-visible invasive ductal carcinoma ≤2 cm, grade 1–2, ER/PR-positive, HER2-negative, and no clinical or radiologic lymph node involvement who agree to randomization.
Not a fit: Patients with multifocal disease, extensive intraductal component, skin or muscle invasion, prior treatment for the current cancer, or who are pregnant or breastfeeding are unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, this approach could offer a less invasive treatment that preserves breast appearance while maintaining cancer control.
How similar studies have performed: Ablative techniques such as cryoablation have shown promising results in small studies, but the hybrid cryo-thermal approach is relatively novel and has not been widely compared with surgery in large randomized trials.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Beijing, Beijing Municipality
- Peking University People's Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: yuan peng, doctor
- Email: 13671287670@163.com
- Phone: 86+13671287670
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.