CRYO-1: Cryoablation in Elderly Patients With Early-Stage Breast Cancer.

NCT07398118 | Not Yet Recruiting

• 1 other identifier: R25.102
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 3

Brief Summary

This study looks at a new way to treat early-stage breast cancer in older adults using a freezing technique called cryoablation. Older adults with early-stage breast cancer are usually treated with surgery or primary endocrine therapy (hormone therapy). While these treatments can be effective, they may also be burdensome. Surgery can lead to pain, slow recovery, or complications, and primary endocrine therapy often requires long-term medication and may cause side effects or stop working over time. Cryoablation may offer a less invasive treatment option. The goal of this study is to find out whether cryoablation can be safely and successfully used as the main treatment for older adults with early-stage breast cancer. Cryoablation destroys the tumour by freezing it. The procedure is performed through the skin using imaging guidance and does not involve surgical removal of the tumour. Participants in this study are adults aged 70 years or older who have a small breast tumour that has not spread to the lymph nodes. All participants receive cryoablation as a single treatment. After the procedure, participants are followed closely. Researchers will collect information on side effects, recovery, whether additional treatment is needed, and how participants experience the treatment. Quality of life will also be assessed. This study is carried out in several hospitals. All participants must give written informed consent before taking part. The results of this study may help determine whether cryoablation could be a safe and practical treatment option for older adults with early-stage breast cancer and guide future research.

Conditions

Breast Cancer Stage I; Breast Cancer Early Stage Breast Cancer (Stage 1-3)

Keywords

Cryoablation; Early-stage breast cancer; Non-curative; Elderly; Minimally invasive treatment; Breast tumour; Local tumour control; Feasibility study; Cryotherapy; Non-surgical treatment

Outcome Measures

Primary Outcomes (1)

• Feasibility and acute safety of cryoablation

  Feasibility is defined as successful completion of the cryoablation procedure as planned. Acute safety is assessed by the incidence of treatment-related adverse events following cryoablation, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Acute toxicity is graded according to the CTCAE v5.0 grading system, which classifies adverse events on an ordinal scale from Grade 1 (mild) to Grade 5 (death related to adverse event). The minimum score is Grade 1 and the maximum possible score is Grade 5. Higher grades indicate more severe toxicity (worse outcome).

  Up to 6 months after cryoablation

Secondary Outcomes (4)

• Technical success of cryoablation

  During the cryoablation procedure

• Local tumour control

  Up to 12 months after cryoablation

• Patient-reported tolerance and quality of life

  Baseline and up to 12 months after cryoablation

• Need for additional locoregional treatment

  Up to 12 months after cryoablation

Study Arms (1)

Cryoablation

EXPERIMENTAL

Participants receive image-guided percutaneous cryoablation as a single primary treatment for early-stage breast cancer. Cryoablation is performed to destroy the tumour by freezing, without surgical excision of the primary tumour.

Procedure: Cryoablation / Cryotherapy

Interventions

Cryoablation / Cryotherapy PROCEDURE

Cryoablation is performed as a percutaneous, image-guided procedure in which the breast tumour is destroyed by controlled freezing. One or more cryoprobes are placed into the tumour under imaging guidance, and freezing cycles are applied to achieve complete local tumour ablation. The procedure is performed as a single intervention without surgical excision of the primary tumour.

Cryoablation

Eligibility Criteria

• Age: 70 Years+
• Gender Eligibility Details: Females
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥ 70 years
• Histologically confirmed invasive breast cancer
• Clinical stage cT1N0M0 based on mammography and ultrasound ER-positive, HER2-negative (IHC 0-1+ or 2+ with negative ISH), any PR status
• Presence of concurrent DCIS is allowed if limited to \<25% of the pre-NST biopsy, with no radiologic suspicion of an extensive component
• Unifocal disease \<2 cm, well visualized on ultrasound, with a minimum distance of ≥5 mm from the skin, nipple and thoracic wall
• Ability and willingness to comply with project requirements
• Preoperative endocrine therapy is allowed
• Written informed consent given by the subject

You may not qualify if:

• Pure DCIS lesions without invasive component
• Extensive calcifications on imaging suggestive of widespread disease
• Invasive lobular carcinoma (as assessed by IHC)
• Triple-negative or HER2-positive subtype (defined as (IHC 3+ or ISH positive)
• History of ipsilateral breast cancer or DCIS
• Prior ipsilateral radiotherapy
• Inability to communicate in Dutch or English language

Sponsors & Collaborators

• Antoni van Leeuwenhoek Hospital: collaborator
• St. Antonius Hospital: lead
• Amphia Hospital: collaborator
• Rijnstate Hospital: collaborator

Study Sites (3)

Rijnstate Hospital

Arnhem, Gelderland, 6836 BH, Netherlands

Location

Amphia Hospital

Breda, North Brabant, 4818 CK, Netherlands

Location

Antoni van Leeuwenhoek - Nederlands Kanker Instituut

Amsterdam, North Holland, 1066 CX, Netherlands

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Cryosurgery; Cryotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative; Therapeutics

Central Study Contacts

Iza Stekelenburg, MD

CONTACT

+31657835198; i.stekelenburg@antoniusziekenhuis.nl

Annemiek Doeksen, MD, PhD

CONTACT

+31 616608284; a.doeksen@antoniusziekenhuis.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinating investigator

Model Details: This study uses a single-arm interventional model in which all participants undergo image-guided cryoablation as a one-time primary treatment. The study is designed to assess feasibility and safety in a selected population without randomisation or comparison to standard treatment.

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 9, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (3)