Monitoring luminAl Breast Cancer Through the Evaluation of Mutational and epiGeNEtic alteraTIons of Circulating ESR1 DNA (MAGNETIC1)
Hormone Receptor Positive Breast Carcinoma, Breast Neoplasms, Neoplasms, Breast
About this trial
This is an interventional other trial for Hormone Receptor Positive Breast Carcinoma focused on measuring Epigenetics, Liquid biopsy, ctDNA, ESR1 Gene Mutation, Biomarker, HR-positive HER2-negative, Advanced breast cancer, CDK4/6, Antineoplastic Agents Hormonal
Eligibility Criteria
Inclusion Criteria: Histologically proven diagnosis of adenocarcinoma of the breast with evidence of metastatic disease. ER positive tumor ≥ 1% HER2 negative breast cancer by FISH or IHC (IHC 0,1+, 2+ and/or FISH HER2: CEP17 ratio < 2.0) Females, 18 years of age or older Candidate to first-line endocrine therapy (LH-RH analogue for premenopausal women is allowed) Signed and dated informed consent document indicating that the subject (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrollment. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures. Exclusion Criteria: Diagnosis of any secondary malignancy within the last 3 years, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix. Prior endocrine therapy for metastatic disease
Sites / Locations
- Asst Papa Giovanni Xxiii- BergamoRecruiting
- Centro di Riferimento Oncologico - AvianoRecruiting
- Asst Ospedali Civili Di BresciaRecruiting
- Azienda Ospedaliero Universitaria Policlinico G. Rodolico- San Marco-CataniaRecruiting
- Universita' Degli Studi Di Napoli Federico IiRecruiting
- azienda sanitaria universitaria friuli centrale- UdineRecruiting
- Ospedale San Bortolo- Azienda Ulss8 BericaRecruiting
Arms of the Study
Arm 1
Experimental
Hormone-receptor positive MBC
Women with hormone receptor-positive MBC, that will be eligible for endocrine therapy as first line treatment