Status:
COMPLETED
Pamidronate Administration in Breast Cancer Patients With Bone Metastases
Lead Sponsor:
Spanish Breast Cancer Research Group
Collaborating Sponsors:
Novartis
Conditions:
Breast Cancer
Neoplasm Metastasis
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief 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 d...
Detailed Description
Background: Pamidronate (PMT) is effective in reducing skeletal related events (SRE) in breast cancer (BC) patients with bone metastasis (BM). Its best way of administration and optimum treatment dura...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 18 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 4 2004
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT00128297
Start Date
October 18 2000
End Date
June 4 2004
Last Update
March 28 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Spanish Breast Cancer Research Group (GEICAM)
San Sebastián de los Reyes, Madrid, Spain, 28700