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Luminal Breast Cancer Cryoablation

ConditionsBreast CancerBreast Cancer (Early Breast Cancer)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorLucía Graña López

About this trial

LUBRECA will evaluate the safety and efficacy of cryoablation with liquid nitrogen to treat cT1cN0 luminal breast cancer diagnosed in postmenopausal women

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Infiltrating lobular carcinoma

Extensive in situ component

Multifocality or multicentricity

Contraindication for contrast mammography

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

140 Participants
are divided into 1 treatment group
Group A: Breast cancerOther 1 intervention

Trial outcomes

Primary outcomes

1

Cryoablation success rate

Absence of tumor cells in a surgical specimen

Time frame
30days after cryoablation

Secondary outcomes

1

Proportion of patients who are free of cryoablation related complications per CTCAE v 5.0

Time frame
One day and one week after cryoablation
2

Patient tolerance to cryoablation and surgery

Physicians Global Assessment to measure quality of life (0-10)

Time frame
60 days after cryoablation
3

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%.

Time frame
36 months

Other outcomes

Sponsors and contacts

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

Lucía Graña López

Lead sponsor

Hospital Universitario Lucus Augusti

Sponsor institution

Source ClinicalTrials.gov
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