Pamidronate Administration in Breast Cancer Patients With Bone Metastases (NCT00128297) | Clinical Trial Compass
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 range
18 Years
Sex
FEMALE
See this in plain English?
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pamidronate efficacy to prevent first skeletal event: time until the appearance of the first skeletal event