CRYoablation for Small Tumors As Local Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

750 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-01

Study Completion Date

2030-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

FreezIng bReaST Cancer in Brazil: a Before-after Study

NCT05398497

Breast Cancer Breast Neoplasms

UNKNOWN NA

Percutaneous Cryoablation of Low-risk Early Breast Cancer

NCT06300125

Breast Cancer

RECRUITING

Cryosurgery in Treating Women With Breast Lesions

NCT00020852

Breast Cancer

COMPLETED PHASE1

Cryoablation of Small Breast Tumors in Early Stage Breast Cancer

NCT01992250

Breast Cancer

UNKNOWN NA

Cryoablation as a Minimally Invasive Alternative to Surgery for Managing Ductal Carcinoma In Situ

NCT05218044

Ductal Carcinoma in Situ

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study compares cryoablation with breast surgery for the treatment of early-stage breast cancer (T1N0M0), evaluating locoregional recurrence, cost-minimization, and disease-free survival.

The primary objective is to demonstrate the non-inferiority of cryoablation compared to breast surgery for local treatment of early-stage breast cancer over five years, as well as to perform a cost-minimization analysis to compare the direct costs of both treatments over one year.

The secondary objectives include assessing locoregional recurrence at one year, evaluating disease-free survival and overall survival over five years, analyzing circulating tumor cells (CTCs) as prognostic factors and for monitoring cryoablation at baseline (study inclusion), six months, and twelve months, measuring patient satisfaction one year after randomization using the Breast-Q questionnaire, and assessing quality of life using the EQ-5D questionnaire.

Cryoablation is a nonsurgical, minimally invasive technique that destroys tumor tissue through cyclic freezing and thawing using cryoprobes. This process induces cellular death without requiring hospitalization, allowing for faster recovery.

Additionally, the study incorporates a de-escalated and personalized approach to breast cancer treatment by omitting sentinel lymph node biopsy, integrating ultrahypofractionated radiotherapy, and utilizing liquid biopsy.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer Breast Neoplasm

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The initial 750 participants will be randomized in a 1:1 manner to either cryoablation or breast surgery. This is a Phase 3 randomized trial evaluating the efficacy and safety of cryoablation compared to breast surgery for early-stage breast cancer. Although the intervention does not involve drugs or biologics, it meets the criteria of a Phase 3 trial as a confirmatory study of an interventional procedure.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cryoablation

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.

Group Type EXPERIMENTAL

No interventions assigned to this group

Breast Surgery (Lumpectomy or Mastectomy)

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.

Group Type ACTIVE_COMPARATOR

Breast Surgery (Lumpectomy or Mastectomy)

Intervention Type PROCEDURE

Surgery can be performed as lumpectomy or mastectomy and axillary surgery, preferably sentinel lymph node biopsy.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

cryoablation

Two devices can be used to perform cryoablation: Cryocare® and ProSense IceCure®:

* Cryocare® - This procedure utilizes two types of gases: argon gas for freezing and helium gas for thawing.
* ProSense IceCure® - This procedure uses extremely low temperatures generated by liquid nitrogen (LN2) to freeze and destroy the target tissue, without the need for an additional gas.

Intervention Type PROCEDURE

Breast Surgery (Lumpectomy or Mastectomy)

Surgery can be performed as lumpectomy or mastectomy and axillary surgery, preferably sentinel lymph node biopsy.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No