Health TrialsbyHealthPanel

Cryoablation Versus Lumpectomy in Early-Stage Breast Cancer

ConditionEarly-Stage Breast Cancer
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age60+
SponsorFranciscus Gasthuis & Vlietland (Hospital)

About this trial

The goal of this randomised controlled trial is to compare ipsilateral breast cancer recurrence rates in patients with early-stage breast cancer between patients treated with breast conserving surgery and patient treated with percutaneous cryo-ablation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Women

Age > 60 years

Postmenopausal (no menstrual period for at least 12 months or in case of an intra-uterine device (IUD) hormone levels that indicate the menopause: follicle stimulating hormone (FSH) > 20 IE/l and estradiol < 100 pmol/l)

Histopathological confirmed primary invasive ER+/HER2- type breast cancer

Disqualifiers

History of invasive breast cancer

Breast augmentation

BRCA-1 or 2 gene mutation carrier

Lobular carcinoma

Trial design

Design model

Crossover

Treatments tested in this trial

  • Percutaneous cryoablation

    Procedure/Surgery

    In this trial, the IceCure Prosense Cryoablation System will be used to execute the percutaneous cryoablation procedure.

  • Breast-conserving surgery

    Procedure/Surgery

    Breast-conserving surgery

Treatment groups

938 Participants
are divided into 2 treatment groups
Group A: Patients will be treated with ultrasound-guided percutaneous cryoablationActive comparator 1 intervention
Group B: Breast-conserving surgeryOther 1 intervention

Trial outcomes

Primary outcomes

1

Ipsilateral breast cancer recurrence

Proportion of ipsilateral breast cancer recurrences (IBTR) after 5 years in both study arms.

Time frame
Until 5 years after the intervention

Secondary outcomes

1

Complication Rate

The proportion of complications within 30 days (percentage Clavien-Dindo classification).

Time frame
Within 30 days after the intervention
2

Regional breast cancer recurrences

Regional breast cancer recurrences, defined as clinically, radiologically, and/or histologically confirmed recurrence in regional lymph nodes.

Time frame
Until 5 years after the intervention
3

Disease Free Survival

Disease free survival (DFS) is defined as the time from date of intervention to the first occurrence of recurrent disease of the same histological characteristics as the primary tumor and in the same quadrant as the primary tumor

Time frame
until 15 years after the intervention
4

Overall Survival

Overall survival (OS) is defined as the time from breast cancer diagnosis to death from any cause.

Time frame
through study completion, an average of 15 years

Other outcomes

1

Any other parameters

To explore patient- or tumor-related factors that may influence complete ablation or surgical outcomes, including breast density and other relevant parameters.

Time frame
until the end of the study, which is an average of 5 years

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Franciscus Gasthuis & Vlietland (Hospital)

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: