Clinical trial · Interventional
Cryoablation of Small Breast Tumors in Early Stage Breast Cancer
Freezing Alone Instead of Resection Of Small Breast Tumors: A Study of Cryoablation in the Management of Early Stage Breast Cancer
NCT01992250CI-TRIAL-00032621FROSTunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study examines the use of cryoablation as an alternative to surgery in the treatment of early stage invasive breast cancer. The hypothesis is that cryoablation will complete ablation and destroy the tumor in a selected population of women who may otherwise be adequately treated with surgery.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Visica 2 Treatment System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Low Risk - Age 70+
- description
- Age 70+. Patients treated with the Visica 2 Treatment System, followed by adjuvant therapies
- interventionNames
- Device: Visica 2 Treatment System
- type
- OTHER
- label
- Moderate Risk - Age 50-69
- description
- Age between 50-69. Patients treated with the Visica 2 Treatment System, followed by adjuvant therapies
- interventionNames
- Device: Visica 2 Treatment System
Primary outcomes (1)
- measure
- Tumor ablation occurence
- timeFrame
- Within 6 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 50 2. Unifocal primary invasive breast carcinoma diagnosed by core needle biopsy 3. Maximum tumor size ≤1.5 cm in its greatest diameter 4. Ultrasound visible lesion(s) 5. Clinically node negative, hormone receptor positive (+). HER2 negative (-), with \<25% intraductal component in the aggregate. 6. Unilateral or bilateral disease meeting study criteria 7. Physical and emotional ability to undergo baseline and follow-up breast MRIs and serial breast cosmesis analysis 8. Patient agrees to receive a 5 year minimum course of endocrine therapy following cryoablation for control of systemic disease Exclusion Criteria: 1. Prior treatment (e.g., open surgical biopsy, lumpectomy) of index cancer 2. Ductal carcinoma in-situ with microinvasions (T1mic) 3. Multifocal or multicentric invasive breast carcinoma 4. Prior or planned neoadjuvant systemic therapy for breast cancer 5. Tumor with ≥25% IDC components
References
Publications (0)
Data not yet available
No reference posted for this study.