Breast Cancer, Neoplasm Metastasis
Conditions
Keywords
Non-symptomatic bone metastases.
Brief summary
This is an open-label, randomized, multicenter phase III trial to assess the efficacy of early administration of zoledronate versus observation in delaying bone-related symptoms in metastatic breast cancer patients.
Detailed description
Patients will be randomised to receive 4 mg zoledronate every 3-4 weeks versus observation until bone-related symptoms appear, or up to 12 months. One hundred twelve patients per treatment arm will be enrolled in the study. Once bone-related symptoms appear, study participation is over. During the study, the following will be assessed: * quality of life, * performance status, * pain rating, * analgesic administration and * adverse events The principal objective is the delay in bone-related symptoms in those patients with early zoledronate administration.
Interventions
DRUGZoledronic acid
Sponsors
Novartis
Spanish Breast Cancer Research Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Written informed consent. * Age \>= 18 years old. * Metastatic breast cancer patients with lytic, sclerotic or mixed bone lesions. * Non-symptomatic bone lesions, defined as pain absence, lack of bone complications (fracture, hypercalcemia, Central Nervous System (CNS) compression), no need of analgesic chronic administration for bone disease. * A maximum of two chemotherapy lines for metastatic disease. * A maximum of two hormone therapy lines for metastatic disease. * Normal, minimally altered renal function (serum creatinine \< 1.5 x Upper Normal Limit (UNL)). * Normal serum calcium levels. * Performance status 0,1 (World Health Organization (WHO)). * Negative pregnancy test before study recruitment.
Exclusion criteria
* Previous treatment with bisphosphonates or raloxifene in the 30 days prior to randomization. * Metastasis in CNS. * History of hypersensitivity to bisphosphonates. * Pregnant or lactating women. * Third chemotherapy line for metastatic disease. * Third hormone therapy line for metastatic disease. * Males.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to first bone metastases | Up to disease progression | The main variable of evaluation is the time until the appearance of first bone metastases. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life per treatment arm | Up to disease progression | Quality of Life (QoL) will be measured with Short Form (SF)-36 questionnaire and Short questionnaire for the evaluation of pain since baseline visit and during all treatment period delivered to the patient before the start of each visit. |
| The Number of Participants Who Experienced Adverse Events (AE) | Through study treatment | Safety will be assessed by standard clinical and laboratory tests. Adverse events grade will be defined by the NCI CTCAE. |
Countries
Spain
Outcome results
None listed