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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age70+
SponsorSt. Antonius Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Cryoablation / Cryotherapy

Treatment groups

61 Participants
are divided into 1 treatment group

Sponsors and collaborators

St. Antonius Hospital

Lead sponsor

Amphia Hospital

Collaborator

Rijnstate Hospital

Collaborator

Antoni van Leeuwenhoek Hospital

Collaborator