Overview

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.