CRYoablation for Small Tumors As Local Treatment - SIX Trial

NCT06839001 | Recruiting Phase 3

• 1 other identifier: 7.241.846
• Study Type: interventional
• Target: 750
• Locations: 1 country
• Sites: 2

Brief Summary

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

Breast Cancer; Breast Neoplasm

Keywords

Breast Cancer; Minimally Invasive Surgical Procedures; Cryoablation; Locoregional Recurrence; Cost-Minimization Analysis

Outcome Measures

Primary Outcomes (2)

• Locoregional recurrence (LRR)

  LRR was defined as recurrence in the ipsilateral breast or chest wall, as well as in the ipsilateral axillary, supraclavicular/infraclavicular region, or internal mammary lymph nodes detected during follow-up, regardless of whether distant metastasis occurred before, after, or simultaneously.

  5 years

• Cost-minimization

  A cost-minimization analysis is an economic technique used to compare the costs of different interventions or treatments that produce equivalent outcomes in terms of efficacy and clinical effects. In other words, this analysis is applied when treatments are assumed to have the same clinical effectiveness, and the goal is to determine which one has the lowest cost. It is a type of cost-effectiveness analysis that compares only the costs of two or more technologies, as the health effects resulting from the compared technologies are considered similar. Clinical outcomes will not be taken into account. We will calculate the costs by collecting data on both direct and indirect expenses associated with the treatments. Direct costs will include procedure-related expenses such as equipment, supplies, medical fees, associated tests and consultations, hospitalization costs if applicable, and medication use. Indirect costs, if a societal perspective is considered, will include factors such as ti

  1 year

Secondary Outcomes (6)

• Locoregional recurrence (LRR)

  1 year

• Disease-free survival (DFS)

  5 years

• Overall Survival (OS)

  5 years

• Circulating tumor cells (CTCs)

  1 year

• Patient satisfaction

  1 month

Study Arms (2)

Cryoablation

EXPERIMENTAL

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.

Breast Surgery (Lumpectomy or Mastectomy)

ACTIVE COMPARATOR

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.

Procedure: Breast Surgery (Lumpectomy or Mastectomy)

Interventions

cryoablation PROCEDURE

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.

Breast Surgery (Lumpectomy or Mastectomy) PROCEDURE

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

Breast Surgery (Lumpectomy or Mastectomy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital do Coracao: lead

Study Sites (2)

Research Institute - Hospital do Coracao

São Paulo, São Paulo, 04004-030, Brazil

NOT YET RECRUITING

Research Institute - Hospital do Coracao

São Paulo, São Paulo, 04041-004, Brazil

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Cryosurgery; Mastectomy, Segmental; Mastectomy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Vanessa Monteiro Sanvido, PhD

  Research Institute - Hospital do Coracao

  PRINCIPAL INVESTIGATOR

• Afonso Celso Pinto Nazário, PhD

  Research Institute - Hospital do Coracao

  PRINCIPAL INVESTIGATOR

• Alexandre Biasi Cavalcante, PhD

  Research Institute - Hospital do Coracao

  STUDY DIRECTOR

Central Study Contacts

Vanessa Monteiro Sanvido, PhD, Professor

CONTACT

+55 11 5576484; dravanessasanvido@gmail.com

Afonso Celso Pinto Nazário, PhD, Professor

CONTACT

+55 11 5576484; nazarioafonso@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vanessa Monteiro Sanvido

Model Details: 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.

Study Record Dates

• First Submitted: February 16, 2025
• First Posted: February 21, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2030
• Last Updated: June 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)