The influence of denosumab on the immune system in women after the menopause with HER2 negative breastcancer.

Phase 1

Active, not recruiting

Conditions: Mamma carcinoma
MedDRA version: 20.0 Level: PT Classification code 10057654 Term: Breast cancer female System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2016-005210-22-NL

Lead Sponsor: BOOG Study Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Recruiting

Sex: Not specified

Target Recruitment: 75

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 3/4, stage II or III breast cancer amenable to adjuvant AC-T or ddAC-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=3.0x10^9/l, neutrophils =1.5 x 10^9/l, platelets =100 x 10^9/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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 37
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 38

Exclusion Criteria

•Evidence of distant metastases (M1)
•History of invasive 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.
•Serious other diseases as recent (last 6 months) myocardial infarction, clinical signs of cardiac failure or clinically significant arrhythmias.
•Prior or current bisphosphonate or denosumab usage.
•Osteoporosis as demonstrated on dexa vfa scan, defined as T = 2.5 and/or a vertebral fracture.
•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