CompletedPhase 4

Pamidronate Administration in Breast Cancer Patients With Bone Metastases

Spain152 participantsStarted 2000-10-18

Plain-language summary

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.

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 World Health Organization (WHO) scale. Exclusion Criteria: * 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.

What they're measuring

Pamidronate efficacy to prevent first skeletal event: time until the appearance of the first skeletal event

Timeframe: 18 months

Trial details

NCT IDNCT00128297

SponsorSpanish Breast Cancer Research Group

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2004-06-04

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