Clinical trial · Interventional
CRYoablation for Small Tumors As Local Treatment - SIX Trial
Cryoablation Versus Breast Surgery in the Local Treatment of Early-Stage Breast Cancer - Six Trial
NCT06839001CI-TRIAL-00091464CRYSTAL - SIXrecruitingPhase 3ClinicalTrials.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)
To demonstrate the non-inferiority of cryoablation compared to breast surgery for the local treatment of early-stage breast cancer and to conduct a cost-minimization analysis comparing direct costs between treatments.
Conditions
Conditions (2)
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 |
| Breast Neoplasm | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Breast Surgery (Lumpectomy or Mastectomy) | Procedure | — | UNRESOLVED |
| cryoablation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cryoablation
- description
- Patients will be treated with cryoablation using a Cryoprobe under real-time ultrasound guidance and local anesthesia. The cryoablation procedure consists of a freezing phase followed by passive thawing, ending with a second freezing cycle. It is recommended to use 6 minutes of freezing and 4 minutes of thawing with Cryocare, and 10 minutes of freezing and 10 minutes of thawing with ProSense IceCure®. The freeze-thaw-freeze times may be adjusted at the physician's discretion depending on tumor size. Patients will be treated with cryoablation (Day 1) using a single Cryoprobe, followed by adjuvant treatment. In cases where radiotherapy is indicated, the preferred regimen will be the 5-fraction schedule. If the 5-fraction regimen is not feasible, the radiation oncologist will be allowed to adjust the fractionation as needed. Patients assigned to the cryoablation group will not undergo axillary surgery, as axillary surgery will be omitted.
- type
- ACTIVE_COMPARATOR
- label
- Breast Surgery (Lumpectomy or Mastectomy)
- description
- Surgery will be performed under general anesthesia according to standard operative procedures at the hospital of origin. Surgery may be performed as either a lumpectomy or a mastectomy, along with a sentinel lymph node biopsy. After surgery, patients will undergo adjuvant treatment as indicated. If radiotherapy is required, the preferred regimen will be the 5-fraction schedule. If the 5-fraction regimen is not feasible, the radiation oncologist will be allowed to adjust the fractionation as needed.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Unifocal primary invasive breast carcinoma * Tumor size ≤ 2.0 cm (T1) * Complete pathological report (including results for ER, PR, HER2, Ki-67, and FISH report for the ERBB2 gene, if necessary) * Lesion visible on ultrasound * Surgical treatment would be the first option, regardless of immunohistochemistry results Exclusion Criteria: * Multifocal or multicentric invasive breast carcinoma * Ductal carcinoma in situ * Breast cancer with skin involvement * Clinically positive axilla (N1, N2 or N3) * Distance from lesion and skin less than 5 mm * Prior neoadjuvant systemic therapy for breast cancer * Distant metastasis
References
Publications (0)
Data not yet available
No reference posted for this study.