Breast Cancer, Breast Cancer (Early Breast Cancer)
Conditions
Keywords
Cryoablation, Liquid nitrogen, Cryosurgery, Percutaneous treatment
Brief summary
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.
Interventions
DEVICECryoablation 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
Sponsors
Lucía Graña López
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Infiltrating lobular carcinoma * Extensive in situ component * Multifocality or multicentricity * Contraindication for contrast mammography * Not candidate for surgery * Distant metastasis -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cryoablation success rate | 30days after cryoablation | Absence of tumor cells in a surgical specimen |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients who are free of cryoablation related complications per CTCAE v 5.0 | One day and one week after cryoablation | — |
| Patient tolerance to cryoablation and surgery | 60 days after cryoablation | Physicians Global Assessment to measure quality of life (0-10) |
| Analyze the impact of broadening the inclusion criteria comparing to previous trials | 36 months | 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%. |
Countries
Spain
Contacts
CONTACTLucía Graña López, PhD
PRINCIPAL_INVESTIGATORLucía Graña López, PhD
Hospital Universitario Lucus Augusti
Outcome results
None listed