Pamidronate Administration in Breast Cancer Patients With Bone Metastases
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The study objective is to evaluate the differences, in terms of first occurrence of a skeletal event, in patients with breast cancer and symptomatic bone metastases, when pamidronate is administered during 2 years, or when it is administered during 6 months, followed by a six month rest period, and again a 6 month treatment period.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Written informed consent.
Up to two previous or current hormone therapy treatments for metastatic breast cancer are allowed.
Normal or borderline renal function (serum creatinine < 1.5 x upper normal limit [UNL]).
Normal calcium levels in serum, or slightly non-symptomatic high levels (< 1.25 x UNL).
Performance status 0, I or II in WHO scale.
Treatment with bisphosphonates in the 30 previous days, or any time if the indication was treatment of metastatic bone lesions.
Treatment with bisphosphonates is only allowed if the indication is hypercalcaemia.
Metastases in central nervous system (CNS).
Hypersensitivity to bisphosphonates or other components of the formula.
Pregnant or lactating women.
Previous or current treatment with a second chemotherapy line or a third hormone therapy line for metastatic disease.