Overview

Neoadjuvant Endocrine Therapy for pre- and postmenopausal women with T4 Nany or TanyN2-3 estrogen receptor (ER) -positive, progrsteron receptor (PR) -positive and HER2 negative breast cancer. Real Clinical Practice in Russia.

Eligibility

Inclusion Criteria:

        Histologically confirmed of hormone receptor-positive (HR +), human epidermal growth factor
        receptor 2-negative (HER2-) invasive breast cancer T4 Nany or Tany N2-N3 premenopausal or
        menopausal women aged 18 years or older. No evidence of metastasis (M0) No prior hormonal,
        chemotherapy or radiotherapy is allowed. No breast operation other than biopsy to make
        diagnosis is allowed.
        Postmenopausal women, defined as women meeting any of the following criteria:
        Age ≥ 60 years Age ≥ 45 years with amenorrhea ≥ 12 months in the moment of breast cancer
        diagnosis and an intact uterus Prior bilateral ovariectomy In case previous hysterectomy,
        follicle stimulating hormone (FSH) and estradiol levels within the postmenopausal range
        (using local laboratory ranges)* * In patients previously treated with a luteinizing
        hormone releasing hormone (LH-RH) analogue, the last extended release formulation should
        have been administered more than 6 months before randomisation, and menses must not have
        reappeared.
        For women of childbearing potential who are sexually active, agreement to use a highly
        effective, non-hormonal form of contraception or two effective forms of non-hormonal
        contraception during and for at least 6 months post-treatment.Eastern Cooperative Oncology
        Group (ECOG) performance status 0/1/2 No personal history of breast cancer within the last
        5 years
        Exclusion Criteria:
        Patients non-candidate for breast surgery Patients with previously treated breast cancer
        during the last 5 years or receiving another concomitant anticancer treatment like
        chemotherapy, immunotherapy, endocrine Patient whose general clinical condition does not
        consider postponing surgery
        Inadequate organ function, evidenced by the following laboratory results:
        Absolute neutrophil count <1,500 cells/mm3 Platelet count <100,000 cells/mm3 Hemoglobin <9
        g/dL Total bilirubin greater than 1,5 times the upper limit of normal (ULN) (unless the
        patient has documented Gilbert's syndrome) Aspartate aminotransferase (AST [SGOT]) or
        alanine aminotransferase (ALT [SGPT]) >2.5 x ULN Serum creatinine >2.0 mg/dL and/or 177
        μmol/L clearance creatinine <50mL/min (calculated by Cockcroft-Gault method) International
        normalized ratio (INR) and activated partial thromboplastin time (aPTT) or partial
        thromboplastin time (PTT) >1.5 x ULN (unless on therapeutic coagulation) 9. Uncontrolled
        hypertension (systolic >150 mmHg and/or diastolic > 100 mmHg) or clinically significant
        (i.e. active) cardiovascular disease: cerebrovascular accident/stroke or myocardial
        infarction within 6 months prior to first study medication; unstable angina; CHF of New
        York Heart Association (NYHA) Grade II or higher; or serious cardiac arrhythmia requiring
        medication.
        Patients with a history of long-QT syndrome or documented family history of long-QT
        syndrome.
        QTc >470 12. serum potassium level < LLN 13. Uncontrolled intercurrent illness including
        but not limited to, known active infection with human immunodeficiency virus (HIV),
        hepatitis B or C virus or psychiatric illness/social situations that would limit compliance
        with study requirements.
        Assessed by the investigator to be unable or unwilling to comply with the requirements of
        the protocol.
        Pregnant or breastfeeding patients