N/A
Completed N=206
Cryoablation of Low Risk Small Breast Cancer- ICE3 Trial
Source: ClinicalTrials.gov NCT02200705 ↗Enrolled (actual)
206
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcomePrimary: Local Inbreast Breast Tumor Recurrence (IBTR) Rate — 4.3 Percentage of participants with IBTR
Summary
To evaluate the efficacy of cryoablation without lumpectomy and its impact on local and distant recurrence of early stage breast cancer .
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Local Inbreast Breast Tumor Recurrence (IBTR) Rate |
4.3 | — |
| SECONDARY Complete Ablation of Primary Tumor |
— | — |
| SECONDARY Improvement or Maintenance of Subject's Quality of Life |
— | — |
| SECONDARY Breast Cosmetics Satisfaction |
— | — |
| SECONDARY Regional Recurrence Rate |
— | — |
| SECONDARY Distant Metastases Rate |
— | — |
| SECONDARY Disease-free Survival (DFS) |
— | — |
| SECONDARY Overall Survival |
— | — |
| SECONDARY Breast Cancer Survival. |
— | — |
| SECONDARY Adverse Events |
— | — |
Eligibility Criteria
Inclusion Criteria
- Competent to sign informed consent
- Diagnosis of invasive ductal breast carcinoma by core needle biopsy, meeting the following criteria:
- Unifocal primary disease NOTE: Patients with multifocal and/or multicentric in breast cancer, or evidence of EIC are NOT eligible. Patients with contralateral disease will remain eligible.
- Tumor size ≤1.5 cm in greatest diameter in the axis parallel to the treatment probe AND ≤1.5 cm in the axis anti-parallel to the treatment probe AND ≤1.5 cm in Anterior/ Posterior dimension. Tumor size ≤1.5 cm in greatest diameter as measured by breast ultrasound, mammogram and/or MRI. The largest dimension measured will be used to determine eligibility.
- Nottingham grade 1-2. Specifically, nuclear and mitotic scores must be less than or equal to 2.
- Estrogen receptor-positive, progesterone receptor-positive, HER2 negative
- Age>= 50
- Breast size adequate for safe cryoablation
- Lesion must be sonographically visible at the time of treatment.
- History of previously treated ipsilateral or contralateral breast carcinoma is not an exclusion criteria if the investigator is certain newly diagnosed carcinoma is new unifocal primary tumor.
Exclusion Criteria
- Presence of lobular carcinoma
- Presence of luminal B pathology
- Nottingham score of 3 (specially nuclear and mitotic score>2)
- Presence of microinvasion, or invasive breast carcinoma with extensive intraductal component (EIC)
- Presence of multifocal and/or multicentric in breast cancer
- Presence of multifocal calcifications
- Presence of prior or concurrent neoadjuvant chemotherapy for breast cancer
- Presence of prior en bloc open surgical biopsy and/or lumpectomy for diagnosis/treatment of the index breast cancer
- Patient that is not suitable to cryoablation procedure according to the physician opinion
- ER AND PR negative, or Her2 positive noted on pre-cryo biopsy
Data sourced from ClinicalTrials.gov (NCT02200705). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.