Evidence map›Paper›PMID 41538117›Full record

Trial reportAnnals of surgical oncology2026

Cryoablation: A Minimally Invasive Alternative for Early-Stage Breast Cancer: 6-Year Outcomes of the FROST Clinical Trial.

D R Holmes, S Manoian, R Layeequr Rahman, R C Ward, N Z Carp, M Plaza, K Kozlowski, S Abe, L Bailey, L Kruper and 4 more

Registry-linked trialAbstract readMulticenter StudyClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of surgical oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01992250 (Freezing Alone Instead of Resection Of Small Breast Tumors), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01992250 naunknown statusnot on this map

Freezing Alone Instead of Resection Of Small Breast Tumors: A Study of Cryoablation in the Management of Early Stage Breast Cancer

TypeinterventionalSponsorSanarus Technologies, Inc.Ran2013 to 2023Enrolled200ConditionsBreast CancerArmsVisica 2 Treatment System
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

D R HolmesAdventist Health Glendale, Glendale, CA, USA. info@cryoablation.com.
S ManoianAdventist Health Glendale, Glendale, CA, USA.
R Layeequr RahmanTexas Tech University Health Sciences Center, Lubbock, TX, USA.
R C WardBrown University Warren Alpert Medical School, Providence, RI, USA.
N Z CarpLankenau Medical Center, Wynnewood, PA, USA.
M PlazaHampton Roads Radiology Associates, Virginia Beach, VA, USA.
K KozlowskiKnoxville Comprehensive Breast Center, Knoxville, TN, USA.
S AbeUniversity of California San Francisco, San Francisco, CA, USA.
L BaileyAlta Bates Summit Medical Center, Oakland, CA, USA.
L KruperMoffitt Cancer Center, Tampa, FL, USA.
V JonesCity of Hope Comprehensive Cancer Center, Duarte, CA, USA.
S PattersonMagnolia Breast Center, Naples, FL, USA.
J TamayoOgden Regional Medical Center, Ogden, USA.
P LittrupUniversity of Rochester Medical Center, Rochester, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCryoablation is emerging as a minimally invasive alternative to lumpectomy for select women with early-stage breast cancer. The FROST trial (NCT01992250) was a prospective, phase 2 multicenter study evaluating the outcome of cryoablation in the management of stage I, hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-negative invasive ductal carcinoma.

methodsWomen 50 years old or older with unifocal, ultrasound-visible tumors were stratified by age: stratum 1 (age ≥70 years, endocrine therapy only) and stratum 2 (age 50-69 years, endocrine therapy + radiotherapy + optional sentinel node biopsy). Cryoablation was performed using a single cryoprobe under ultrasound guidance. Core biopsy 6 months after ablation was performed to confirm complete ablation. Patients were followed with clinical exams and imaging.

resultsThe study included 83 completed cryoablations and follow-up evaluations. The median tumor size was 9 mm. More than 85% of the subjects in each group received endocrine therapy (stratum 1 [89%, 43/48], stratum 2 [85.7%, 30/35]) and 74.3% (26/35) of the subjects in stratum 2 received recommended whole-breast radiation. Of the 83 patients, 82 received a post-ablation core biopsy 6 months after cryoablation showing no residual cancer, and 1 patient declined a core biopsy. During a median follow-up period of 6.1 years, the 5-year ipsilateral breast tumor recurrence rate (IBTR) was 3.64% overall (stratum 1, 2.08%; stratum 2, 5.80%). The invasive IBTR-free survival rate was 97.59% overall (stratum 1, 97.92%; stratum 2, 97.14%). No serious adverse events occurred.

conclusionsThe FROST trial adds to the growing body of literature supporting the efficacy and safety of cryoablation and supports ongoing research on cryoablation as a strategy for de-escalating breast cancer therapy.

Indexed as

Breast NeoplasmsCarcinoma, Ductal, BreastCryosurgeryMinimally Invasive Surgical ProceduresNeoplasm Recurrence, LocalAgedAged, 80 and overErb-b2 Receptor Tyrosine KinasesFemaleFollow-Up StudiesHumansMiddle AgedNeoplasm StagingPrognosisProspective StudiesReceptors, EstrogenERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesReceptors, EstrogenReceptors, ProgesteroneAblationBreast cancerCryoablationCryoprobeFROSTMinimally invasive

Identifiers

PMID41538117
PMCPMC12982317

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.