Prevention of Symptomatic Skeletal Events with Denosumab Administered every 4 Weeks versus every 12 Weeks - A Non-Inferiority Phase III trial

Swiss Group for Clinical Cancer Research0 个研究点目标入组 1,380 人开始时间: 2018年9月21日最近更新: 2019年12月10日

试验速览

暂无简介。

•1. Signed informed consent
•2. ECOG Performance 0-2
•3. Age = 18 years
•4. Confirmed diagnosis of breast or prostate cancer before randomization.
•5. Patient has metastatic breast cancer (stage IV, all subtypes allowed except small cells) or prostate cancer (stage IV, exception: small cells) and bone metastases and is planned to receive or is receiving antineoplastic treatment.
•6. Patients with prostate cancer must have evidence of disease Progression on continuous androgen deprivation therapy (CRPC).
•7. Patients must have = three bone metastases (lytic or blastic or mixed).
•8. Corrected serum calcium = 2 mmol/l and = 3 mmol/l (medical treatments to obtain serum calcium levels in the normal range are allowed, as far as no denosumab is used. Maximally one dose of bisphosphonates in the case of hypercalcemia is allowed, if the bisphosphonate was applied at least three weeks before the first dose of denosumab).
•9. Liver transaminases not more than 1.5 x ULN or not more that 3 x ULN with liver metastases. Serum total bilirubin = 1.5 x ULN (= 2.0 x ULN in case of known Gilbert's disease).
•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 1380
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 1380

•1. Definite contraindication for denosumab (e.g. hypocalcemia [Albumin-corrected serum calcium < 2.0 mmol/l]).
•2. History or current evidence of osteonecrosis of the jaw (ONJ).
•3. Non-healed mucosa in oral cavity (by surgery or as a side effect of any other Treatment).
•4. Jaw or dental conditions that require oral surgery or if surgery or invasive dental procedures are planned.
•5. Prior use of denosumab for bone metastases or bisphosphonates to treat bone metastases. Patients treated with denosumab or bisphosphonates against osteopenia or osteoporosis are followed to enter the trial if the last dose was more than 28 days before randomization.
•6. Patients with known osteoporosis (T-score = -2.5) at study entry.
•7. Radiotherapy or surgery to the bone within the last two weeks before randomization or planned within six weeks after randomization.
•8. Presence or history of CNS metastases or leptomeningeal disease. A MRI Evaluation within twelve weeks before randomization must be performed in case of suspicious symptoms.

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