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.

Exclusion Criteria:

* Evidence of distant metastases (M1).
* History of breast cancer.
* Prior chemotherapy or radiation therapy.
* Previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix.
* Prior or current bisphosphonate or denosumab usage.
* Serious other diseases as recent (last 6 months) myocardial infarction, clinical signs of cardiac failure or clinically significant arrhythmias.
* Current active dental problems including dental abscess or infection of the jawbone (maxilla or mandible), non-healed dental or oral surgery, a current or prior diagnosis of osteonecrosis of the jaw or planned invasive dental procedures for the course of the study.
* Known hypersensitivity reaction to any of the components of the treatment.
* Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent.