- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00128297
Pamidronate Administration in Breast Cancer Patients With Bone Metastases
Randomized, Multicentric Phase IV Clinical Trial for the Administration of Pamidronate in Breast Cancer Patients With Bone Metastases
Study Overview
Status
Conditions
Intervention / Treatment
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 duration are still to be determined.
Objective: evaluate the efficacy of continuous administration (arm A) vs. alternate administration (arm B) of PMT to delay time to first SRE in BC pt presenting with symptomatic BM.
Methods: patients aged >18, Eastern Cooperative Oncology Group (ECOG) performance status ≥ 2, adequate renal function, and BC symptomatic BM were eligible. BM was defined as presence of 3 or more hot spots (HS) in skeletal scintigraphy (SS), or any number of HS in SS if osteolytic, osteoblastic or mixed bone lesions determined by radiography, or 2 or less HS in SS if magnetic resonance or CT scan confirmation of BM. Symptomatic BM was defined as pain associated to SS HS, or SRE (pathological fractures or spine cord compression or radiation bone treatment or tumour induced hypercalcemia), or treatment with analgesia due to bone pain. Patients were allowed up to 1 previous chemotherapy and 2 previous hormone therapy lines for metastatic disease. Antineoplastic therapy could be changed at any time during the study. Eligible patients were stratified (isolated bone metastasis or associated to node or skin lesions vs. bone metastasis associated to visceral disease) and randomized to receive 2 hour-iv. PMT 90 mg every 3-4 weeks for 18 months (arm A) or iv. PMT 90 mg every 3-4 weeks for 6 months, followed by a 6 months rest, and a new 6 months on-treatment period (arm B). Quality of Life (QoL) was measured with short form (SF)-36 questionnaire.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Madrid
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San Sebastián de los Reyes, Madrid, Spain, 28700
- Spanish Breast Cancer Research Group (GEICAM)
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Arm A: continuous administration
Pamidronate 90 mg/m2 iv every 3-4 weeks, during 18 months
|
Other Names:
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Experimental: Arm B: alternate administration
Pamidronate 90 mg/m2 iv every 3-4 weeks, during 6 months, followed by a 6 month rest, and a new 6 months treatment period.
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pamidronate efficacy to prevent first skeletal event: time until the appearance of the first skeletal event
Time Frame: 18 months
|
The main variable of evaluation is the time until the appearance of the first skeletal event.
Skeletal event is defined as pathological bone fracture, or spine cord compression, or radiation bone treatment, or tumour induced hypercalcemia
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of skeletal events per treatment arm
Time Frame: 18 months
|
The main variable of evaluation is the time until the appearance of the first skeletal event per arm.
|
18 months
|
Quality of life: Short Form (SF)-36 questionnaire
Time Frame: 18 months
|
Quality of Life (QoL) was measured with Short Form (SF)-36 questionnaire, which is a 36 item, patient-reported survey of patient health.
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section.
Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.
The lower the score, the more disability, and the higher the score the less disability (a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability).
The eight sections are vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health.
It will be completed since baseline visit and during all treatment period delivered to the patient before the start of each visit.
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18 months
|
Overall survival (OS)
Time Frame: 18 months
|
OS will be determined from the date of randomization until the date of death for any reason.
|
18 months
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Study Director, Hospital Clinico Universitario de Valencia
- Study Director: Study Director, Hospital Santa Creu i Sant Pau
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GEICAM 2000-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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