Clinical trial · Interventional
FreezIng bReaST Cancer in Brazil: a Before-after Study
Evaluation of Cryoablation in the Local Treatment of Early Breast Cancer
NCT05398497CI-TRIAL-00060967FIRSTunknownN/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)
Image-guided tumor ablation is a non-surgical, minimally invasive therapy available for local therapy of some carcinomas as an alternative to surgical treatment. This study assesses whether cryoablation can be used as an alternative to surgery in cases of early invasive breast carcinoma.
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 Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cryoablation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Early stage breast cancer up to 2.5 cm
- description
- Patients treated with Cryocare SL followed by traditional surgery, radiotherapy and adjuvant systemic therapy.
- interventionNames
- Device: Cryoablation
Primary outcomes (1)
- measure
- Tumor ablation
- timeFrame
- 1 month
- description
- Successful tumor ablation will be defined as absence of residual viable invasive or in situ carcinoma in the surgical specimen.
Secondary outcomes (3)
- measure
- Negative predictive value of magnetic resonance imaging (MRI)
- timeFrame
- 14 days and 28 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Unifocal primary invasive breast carcinoma * Pathological report should be complete (with the result of ER, PR , HER2, KI67 and FISH report of ERBB2 gene if necessary) * Maximum tumor size ≤2.5 cm in its greatest diameter * Ultrasound visible lesion 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 (1)
- DERIVEDSanvido VM, Bromberg SE, Waitzberg AFL, Gomes JO, Barbante LG, Socolowski LR, Tachibana BMT, Junior AR, Miranda TA, Negrelli KDL, Martins EVDN, Santos RHN, Vianna PM, da Silva LM, Cavalcanti AB, Nazario ACP. Cryoablation for early-stage invasive breast cancer: pathologic and imaging outcomes from the prospective FIRST trial. Breast Cancer Res. 2026 May 19;28(1):128. doi: 10.1186/s13058-026-02302-y. PMID 42157305