Breast cancer MedDRA version: 12.1 Level: LLT Classification code 10057654 Term: Breast cancer female
Conditions
Interventions
Trade Name: ACLASTA
Pharmaceutical Form: Emulsion for infusion
INN or Proposed INN: Zoledronic acid
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Sponsors
AZIENDA OSPEDALIERO UNIVERSITARIA DI CAGLIARI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: age = or> 18 -75 aa; ? ECOG PS 0-2; ? diagnosis of breast cancer histologically confirmed; ? stage of disease (stage I-III; any grading); ? patients with malignant breast cancer with overt osteoporosis in adjuvant setting, already under loco-regional therapy (surgery + / - radiotherapy) and adjuvant chemotherapy (if indicated) at high risk of skeletal events (pathological fractures, spinal compression, radiation at skeleton and use of radioisotopes, orthopedic surgery, modification of analgesic therapy for pain OSEE); ? osteoporosis, defined according to T score = or =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: pregnancy and lactation; ? hypocalcemia; ? impaired renal function with creatinine> 1.4 mg / dl at baseline; ? Concomitant use of nephrotoxic drugs certainly; ? Prior treatment with zoledronic acid or in progress; ? documented hypersensitivity to bisphosphonates; ? presence of serious diseases osteoarticular; ? presence of severe dental disease; ? previous history of malignancies other than breast cancer, excluding basalioma skin and carcinoma in situ of the cervix.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objectives of the study are represented by the evaluation of the safety and efficacy of the drug through the evaluation of the following parameters: ? reduced loss of bone mineral density (BMD or bone mass density); ? assessing the occurrence of skeletal events (SRE) (pathological fractures, spinal compression, radiotherapy to the skeleton and use of radioisotopes, orthopedic surgery, amendment of analgesic therapy for pain OSEE) during the treatment period; ? Time to first SRE; ? Time to onset of each type of SRE; ? reduction of skeletal morbidity rate ie number of SREs / year (calculated on the basis of occurrence of total and vertebral pathological fractures, radiotherapy, surgery, orthopedic, spinal compression, hypercalcemia of malignancy); ? toxicity of the treatment;;Secondary Objective: levels`s changes of laboratory parameters (factors neoangiogenetici, proinflammatory cytokines, markers of bone resorption); ? Changing the quality of life; ? changes dell`ECOG PS; ? overall survival; ? Time to progression of bone cancer (onset of bone metastases); ? Time to progression of neoplasia visceral (appearance of visceral metastases).;Primary end point(s): reduced loss of bone mineral density (BMD or bone mass density); ? assessing the occurrence of skeletal events (SRE) (pathological fractures, spinal compression, radiotherapy to the skeleton and use of radioisotopes, orthopedic surgery, amendment of analgesic therapy for pain OSEE) during the treatment period; ? Time to first SRE; ? Time to onset of each type of SRE; ? reduction of skeletal morbidity rate ie number of SREs / year (calculated on the basis of occurrence of total and vertebral pathological fractures, radiotherapy, surgery, orthopedic, spinal compression, hypercalcemia of malignancy); ? toxicity of the treatment; | — |
Countries
Italy
Outcome results
None listed