Breast CancerLUBRECANCT07447414
Luminal Breast Cancer Cryoablation
A study testing Cryoablation with liquid nitrogen (Prosense® system) in people with Breast Cancer and Breast Cancer (Early Breast Cancer), run by Lucía Graña López at 1 site in Spain.
Trial summary
LUBRECA will evaluate the safety and efficacy of cryoablation with liquid nitrogen to treat cT1cN0 luminal breast cancer diagnosed in postmenopausal women Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer, Breast Cancer (Early Breast Cancer)
- What is being tested?
- Cryoablation with liquid nitrogen (Prosense® system)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteSpain
- Study dates
- 8 Apr 2026to Dec 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Postmenopausal women diagnosed with invasive breast cancer by core needle biopsy or vacuum-assisted biopsy
- Unifocal
- Lesion ≤ 2 cm (on ultrasound and contrast enhanced mammography)
- No axillary lymphadenopathy on ultrasound
- No axillary lymph node involvement on ultrasound.
- Luminal tumor (estrogen and/or progesterone receptor positive)
- HER2 negative
- Signed informed consent
Who cannot join
- Infiltrating lobular carcinoma
- Extensive in situ component
- Multifocality or multicentricity
- Contraindication for contrast mammography
- Not candidate for surgery
- Distant metastasis -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Lucus Augusti
Lugo, Lugo, 27003
About this study
Official title: Cryoablation for the Treatment of Luminal Early Breast Cancer
LUBRECA will evaluate the safety and efficacy of cryoablation with liquid nitrogen to treat cT1cN0 luminal breast cancer diagnosed in postmenopausal women
Read the detailed description
This is a prospective transversal study that will include 140 postmenopausal women with unifocal invasive breast cancer diagnosed with core or vacuum-assisted biopsy, up to 2 cm measured in ultrasound and contrast enhanced mammography, without metastatic lymph nodes in axillary ultrasound, hormone receptor positive and human epidermal factor receptor 2 (HER) negative. Patients with invasive lobular carcinoma, extensive intraductal component, not suitable for surgery or with metastatic disease will be excluded.
Participants will receive cryoablation treatment of the tumor and, after, they will undergo radio-guided surgical resection. The presence of residual viable tumoral cells will be evaluated in the surgical specimen. Axillary evaluation during surgery and adjuvant treatment will be planned accordant to the usual clinical practice.
Cryoablation and surgery side effects and tolerance will be evaluated.
- Conditions
- Breast Cancer, Breast Cancer (Early Breast Cancer)
- Being tested
- Cryoablation with liquid nitrogen (Prosense® system)
- Keywords
- Cryoablation, Liquid nitrogen, Cryosurgery, Percutaneous treatment
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryoablation with liquid nitrogen (Prosense® system)Device
The appropriate cryoprobe (10G or 13G) will be selected depending on the size of the tumor. After injecting local anesthesia, the cryoprobe will be inserted along the longest diameter of the lesion. The tip of the needle will be advanced so that the freezing center is located in the middle of the tumor. Two freezing cycles will be performed, separated by a thawing cycle, all three of the same duration, which depends on the size of the tumor. The goal is a freezing volume with a lethal zone covering the lesion and a safety margin of at least 1 cm. Ultrasound allows real-time monitoring of the expansion of the ice ball during cryoablation. To avoid burning the skin, we will inject warm sterile saline solution when the distance between the ice and the skin surface is less than 0.5 cm
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer | Other | Early stage luminal breast cancers up to 2 cm Receives: Device: Cryoablation with liquid nitrogen (Prosense® system) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cryoablation success rate
Absence of tumor cells in a surgical specimen
Measured: 30days after cryoablation
Secondary outcomes (3)
Proportion of patients who are free of cryoablation related complications per CTCAE v 5.0
Measured: One day and one week after cryoablation
Patient tolerance to cryoablation and surgery
Physicians Global Assessment to measure quality of life (0-10)
Measured: 60 days after cryoablation
Analyze the impact of broadening the inclusion criteria comparing to previous trials
Subgroup analysis: comparing the efficacy of cryoablation in tumors: ≤ 1.5 cm / 1.5-2 cm; grade I-II / grade III; invasive ductal/ others (mucinous, cribriform, tubular, papillary, micropapillary...); proliferation index (ki67) ≤ 20% / 21-50% / > 50%.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start8 Apr 2026
- Primary completionSep 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lucía Graña López
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lucía Graña López, Hospital Universitario Lucus Augusti
- Investigators
- Lucía Graña López, PhD, Principal investigator, Hospital Universitario Lucus Augusti
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07447414
- Sponsor's protocol ID
- 2025/476
- Acronym
- LUBRECA
- Status last verified
- Apr 2026
- First submitted
- 23 Feb 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fine RE, Gilmore RC, Tomkovich KR, Dietz JR, Berry MP, Hernandez LE, Columbus KS, Seedman SA, Fisher CS, Han LK, Manahan ER, Hicks RD, Vaidya RP, Curcio LD, Sevrukov AB, Kenler AS, Taback B, Chen M, Miller ME, Gold L, Anglin BV, Aoun HD, Simmons RM, Feldman SM, Boolbol SK. Cryoablation Without Excision for Early-Stage Breast Cancer: ICE3 Trial 5-Year Follow-Up on Ipsilateral Breast Tumor Recurrence. Ann Surg Oncol. 2024 Oct;31(11):7273-7283. doi: 10.1245/s10434-024-16181-0. Epub 2024 Sep 16.
PubMed 39283572