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