Pamidronate Administration in Breast Cancer Patients With Bone Metastases

• Status: Completed
• Trial end date: 2004-06-04
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Spanish Breast Cancer Research Group
• Collaborator: Novartis
• Treatments: Pamidronate

Criteria

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.