Breast CancerPhase 4NCT00128297
Pamidronate Administration in Breast Cancer Patients With Bone Metastases
A Phase 4 study testing Pamidronate in people with Breast Cancer and Neoplasm Metastasis, run by Spanish Breast Cancer Research Group at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Neoplasm Metastasis
- What is being tested?
- Pamidronate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteSpain
- Study dates
- 18 Oct 2000to 4 Jun 2004
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Spanish Breast Cancer Research Group (GEICAM)
San Sebastián de los Reyes, Madrid, 28700
About this study
Official title: Randomized, Multicentric Phase IV Clinical Trial for the Administration of Pamidronate in Breast Cancer Patients With Bone Metastases
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.
Read the 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.
- Conditions
- Breast Cancer, Neoplasm Metastasis
- Being tested
- Pamidronate
- Keywords
- Breast cancer patients with symptomatic bone metastases
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PamidronateDrug
Also called Aredia
| Study group | Role | What they receive |
|---|---|---|
| Arm A: continuous administration | Active comparator | Pamidronate 90 mg/m2 iv every 3-4 weeks, during 18 months Receives: Drug: Pamidronate |
| Arm B: alternate administration | Experimental | 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. Receives: Drug: Pamidronate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pamidronate efficacy to prevent first skeletal event: time until the appearance of the first skeletal event
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
Measured: 18 months
Secondary outcomes (3)
Number of skeletal events per treatment arm
The main variable of evaluation is the time until the appearance of the first skeletal event per arm.
Measured: 18 months
Quality of life: Short Form (SF)-36 questionnaire
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.
Measured: 18 months
Overall survival (OS)
OS will be determined from the date of randomization until the date of death for any reason.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2005 (estimated)
- Study start18 Oct 2000
- Primary completion4 Jun 2004
- Study completion4 Jun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spanish Breast Cancer Research Group
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauStudy Director, Study director, Hospital Clínico Universitario de Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00128297
- Sponsor's protocol ID
- GEICAM 2000-01
- Status last verified
- Mar 2023
- First submitted
- 8 Aug 2005
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Multicentric Phase IV Clinical Trial for the Administration of Pamidronate in Breast Cancer Patients With Bone Metastases
- ClinicalTrials.gov ID
- NCT00128297
- Acronym / sponsor ID
- GEICAM 2000-01
- Conditions
- Breast Cancer, Neoplasm Metastasis
- Keywords
- Breast cancer patients with symptomatic bone metastases
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Spanish Breast Cancer Research GroupUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- 18 Oct 2000 (actual)
- Primary completion
- 4 Jun 2004 (actual)
- Study completion
- 4 Jun 2004 (actual)
- First posted
- 9 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: continuous administration | Active comparator | Drug: PamidronatePamidronate 90 mg/m2 iv every 3-4 weeks, during 18 months |
| Arm B: alternate administration | Experimental | Drug: PamidronatePamidronate 90 mg/m2 iv every 3-4 weeks, during 6 months, followed by a 6 month rest, and a new 6 months treatment period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PamidronateAlso: Aredia | Drug | Arm A: continuous administration, Arm B: alternate administration |
Primary outcome
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
3 secondary outcomes
Number of skeletal events per treatment arm
Time frame: 18 months
Quality of life: Short Form (SF)-36 questionnaire
Time frame: 18 months
Overall survival (OS)
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
- "Click here for more information about this study:"Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study Director study director
Hospital Clínico Universitario de Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pamidronate in people with Breast Cancer and Neoplasm Metastasis, run by Spanish Breast Cancer Research Group at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pamidronate efficacy to prevent first skeletal event: time until the appearance of the first skeletal event (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023; AzTrials last refreshed its copy on 8 Nov 2026.