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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryoablation for the Treatment of Luminal Early Breast Cancer
- ClinicalTrials.gov ID
- NCT07447414
- Acronym / sponsor ID
- LUBRECA / 2025/476
- Conditions
- Breast Cancer, Breast Cancer (Early Breast Cancer)
- Keywords
- Cryoablation, Liquid nitrogen, Cryosurgery, Percutaneous treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Lucía Graña LópezUniversity, hospital or other
- Study start
- 8 Apr 2026 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
LUBRECA will evaluate the safety and efficacy of cryoablation with liquid nitrogen to treat cT1cN0 luminal breast cancer diagnosed in postmenopausal women
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast cancer | Other | Device: Cryoablation with liquid nitrogen (Prosense® system)Early stage luminal breast cancers up to 2 cm |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (6 listed)
- Infiltrating lobular carcinoma
- Extensive in situ component
- Multifocality or multicentricity
- Contraindication for contrast mammography
- Not candidate for surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cryoablation with liquid nitrogen (Prosense® system)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 | Device | Breast cancer |
Primary outcome
Cryoablation success rate
Time frame: 30days after cryoablation
Absence of tumor cells in a surgical specimen
3 secondary outcomes
Proportion of patients who are free of cryoablation related complications per CTCAE v 5.0
Time frame: One day and one week after cryoablation
Patient tolerance to cryoablation and surgery
Time frame: 60 days after cryoablation
Analyze the impact of broadening the inclusion criteria comparing to previous trials
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Background: PubMed 39283572Fine 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lucía Graña López, PhD principal investigator
Hospital Universitario Lucus Augusti
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lucía Graña López, PhD (0034982296234, grana.lopez.lucia@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cryoablation success rate (time frame: 30days after cryoablation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07447414, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.