MicroRNAs and Prognosis in Breast Cancer (BREMIR)

Casa Sollievo della Sofferenza IRCCS

Status: Completed

Conditions: Breast Cancer Female; Metastases Breast

Treatments: Diagnostic Test: miRNA targeted analysis on plasma samples; Diagnostic Test: miRNA profiling of breast cancer tissues; Diagnostic Test: miRNA targeted analysis on breast cancer tissues

Study type: Observational

Funder types: Other

Identifiers

NCT06555354

BREMIR

Details and patient eligibility

About

Mono-centric, observational retrospective and prospective study, designed for breast cancer patients to identify novel miRNA based biomarker able to predict metastases development in breast cancer patients.

Full description

The potential role of miRNAs will be studied as a predictor of metastases development. miRNAs expression and miRNAs promoter methylation will be evaluated in surgically removed specimens obtained from breast cancer patients at diagnosis. Relevant miRNAs will be first identified by analysing a retrospective breast cancer cohort including at least and subsequently validated on a prospective cohort.

Enrollment: 1,432 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Retrospective Cohort

Inclusion Criteria:

Tissue samples from breast cancer cases diagnosed from 2004 to 2014 for which informed consent for tumour banking and complete clinicopathological and follow up data were available.

Exclusion Criteria:

Pre-surgery neoadjuvant treatment for breast cancer with chemotherapy, lapatinib, trastuzumab, letrozole, anastrozole, exemestane or tamoxifen.

Other cancers diagnosed in the last five years.

Prospective Cohort:

Inclusion Criteria:

Ability to provide written informed consent; Age greater than 18 years; Histological diagnosis of Breast disease; First diagnosis of Breast Cancer; Syncronous distant metastasis absent.

Exclusion Criteria:

Stage IV breast cancer; Pre-surgery neoadjuvant treatment for breast cancer with chemotherapy, lapatinib, trastuzumab, letrozole, anastrozole, exemestane or tamoxifen; Other cancers diagnosed in the last five years; Alteration of mental status, dementia, or any psychiatric condition that might impair the ability to consciously sign the informed consent.

Trial design

1,432 participants in 2 patient groups

Retrospective

Description:

Identification in a retrospective cohort of a miRNA panel associated with the development of distant metastases.The retrospective cohort consists of tumor and normal tissue obtained from breast cancer patients, stored at -80°C at the Laboratory of Oncology. Of these samples, 360 met the inclusion criteria.

Treatment:

Diagnostic Test: miRNA targeted analysis on breast cancer tissues

Diagnostic Test: miRNA profiling of breast cancer tissues

Prospective

Description:

The association between miRNA expression and the clinical course of the disease identified in the retrospective cohort, is being confirmed in an independent prospective cohort. Both normal and tumor tissues of the patients, as well as plasma collected before surgery and at each follow-up time point, is being analyzed. Based on the annual number of surgeries performed at the Breast Surgery Unit, we initially estimated that the prospective cohort would consist of about 500 patients recruited over three years. Since the project was extended for additional two years the actual number of subject recruited was 972. In addition plasma sample for 100 breast benign condition was also collected as controls.

Treatment:

Diagnostic Test: miRNA targeted analysis on breast cancer tissues

Diagnostic Test: miRNA targeted analysis on plasma samples