Study to Identify the Impact of Denosumab on the Immune System in Patients With HER2 Negative Breast Cancer

Inclusion Criteria

• •Postmenopausal, defined as 1 year without menstrual activity, previous bilateral oophorectomy, age older than 60 years or baseline FSH \>20 U/l and estradiol \<110 pmol/l.
• •Clinical stage T1c + grade 3, stage II or III breast cancer amenable to adjuvant AC-T combination chemotherapy.
• •Measurable disease (breast and/or lymph nodes).
• •Histological proven HER2-negative breast cancer in the core biopsy material.
• •WHO 0-2.
• •Adequate bone marrow function (within 4 weeks prior to randomization): WBC≥3.0x109/l, neutrophils ≥1.5 x 109/l, platelets ≥100 x 109/l.
• •Adequate liver function (within 4 weeks prior to randomization): bilirubin ≤1.5 X upper limit of normal (UNL) range, ALAT and/or ASAT ≤2.5 x UNL, Alkaline Phosphatase ≤5 x UNL.
• •Adequate renal function (within 4 weeks prior to randomization): the calculated creatinine clearance should be ≥50 ml/min.
• •Albumin-adjusted serum calcium \> 2.0 mmol/L (8.0mg/dL)
• •Accessible for treatment and follow-up.
• •Written informed consent.