Breast CancerPhase 3NCT00130494
Zoledronic Acid Administration to Metastatic Breast Cancer Patients With Non-symptomatic Bone Lesions
A Phase 3 study testing Zoledronic acid in people with Breast Cancer and Neoplasm Metastasis, run by Spanish Breast Cancer Research Group at 1 site in Spain.
Trial summary
This is an open-label, randomized, multicenter phase III trial to assess the efficacy of early administration of zoledronate versus observation in delaying bone-related symptoms in metastatic breast cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer, Neoplasm Metastasis
- What is being tested?
- Zoledronic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteSpain
- Study dates
- 29 Aug 2002to 22 Oct 2007
- Phase
- Phase 3
- 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent.
- Age >= 18 years old.
- Metastatic breast cancer patients with lytic, sclerotic or mixed bone lesions.
- Non-symptomatic bone lesions, defined as pain absence, lack of bone complications (fracture, hypercalcemia, Central Nervous System (CNS) compression), no need of analgesic chronic administration for bone disease.
- A maximum of two chemotherapy lines for metastatic disease.
- A maximum of two hormone therapy lines for metastatic disease.
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- Normal, minimally altered renal function (serum creatinine < 1.5 x Upper Normal Limit (UNL)).
- Normal serum calcium levels.
- Performance status 0,1 (World Health Organization (WHO)).
- Negative pregnancy test before study recruitment.
Who cannot join
- Previous treatment with bisphosphonates or raloxifene in the 30 days prior to randomization.
- Metastasis in CNS.
- History of hypersensitivity to bisphosphonates.
- Pregnant or lactating women.
- Third chemotherapy line for metastatic disease.
- Third hormone therapy line for metastatic disease.
- Males.
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: Multicenter, Open-label, Randomized Phase III Trial for Administration of Zoledronate to Breast Cancer Metastatic Patients With Non-symptomatic Bone Lesions
This is an open-label, randomized, multicenter phase III trial to assess the efficacy of early administration of zoledronate versus observation in delaying bone-related symptoms in metastatic breast cancer patients.
Read the detailed description
Patients will be randomised to receive 4 mg zoledronate every 3-4 weeks versus observation until bone-related symptoms appear, or up to 12 months. One hundred twelve patients per treatment arm will be enrolled in the study.
Once bone-related symptoms appear, study participation is over. During the study, the following will be assessed:
- quality of life,
- performance status,
- pain rating,
- analgesic administration and
- adverse events The principal objective is the delay in bone-related symptoms in those patients with early zoledronate administration.
- Conditions
- Breast Cancer, Neoplasm Metastasis
- Being tested
- Zoledronic acid
- Keywords
- Non-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.
Zoledronic acidDrug
Also called Zometa
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Zoledronic acid 4 mg | Experimental | Zoledronate 4 mg every 3 or 4 weeks. This arm will receive study treatment from the time of entry into the trial, until the appearance of the symptoms of bone metastases (or a maximum period of 12 months, whichever occurs first). Receives: Drug: Zoledronic acid |
| Arm B: Observation | No intervention | Patients will not receive any treatment with bisphosphonates until the time of onset of symptoms (or a maximum period of 12 months, whichever occurs sooner). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first bone metastases
The main variable of evaluation is the time until the appearance of first bone metastases.
Measured: Up to disease progression
Secondary outcomes (2)
Quality of life per treatment arm
Quality of Life (QoL) will be measured with Short Form (SF)-36 questionnaire and Short questionnaire for the evaluation of pain since baseline visit and during all treatment period delivered to the patient before the start of each visit.
Measured: Up to disease progression
The Number of Participants Who Experienced Adverse Events (AE)
Safety will be assessed by standard clinical and laboratory tests. Adverse events grade will be defined by the NCI CTCAE.
Measured: Through study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2005 (estimated)
- Study start29 Aug 2002
- Primary completion20 Nov 2006
- Study completion22 Oct 2007
Why it stopped: Low recruitment
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 97 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, Hospital Clínico Universitario de ValenciaStudy Director, Study director, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00130494
- Sponsor's protocol ID
- GEICAM 2001-05
- Status last verified
- Apr 2019
- First submitted
- 12 Aug 2005
- Last updated
- 16 Apr 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Open-label, Randomized Phase III Trial for Administration of Zoledronate to Breast Cancer Metastatic Patients With Non-symptomatic Bone Lesions
- ClinicalTrials.gov ID
- NCT00130494
- Acronym / sponsor ID
- GEICAM 2001-05
- Conditions
- Breast Cancer, Neoplasm Metastasis
- Keywords
- Non-symptomatic bone metastases.
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruitment
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Spanish Breast Cancer Research GroupUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- 29 Aug 2002 (actual)
- Primary completion
- 20 Nov 2006 (actual)
- Study completion
- 22 Oct 2007 (actual)
- First posted
- 15 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.
This is an open-label, randomized, multicenter phase III trial to assess the efficacy of early administration of zoledronate versus observation in delaying bone-related symptoms in metastatic breast cancer patients.
Detailed description
Patients will be randomised to receive 4 mg zoledronate every 3-4 weeks versus observation until bone-related symptoms appear, or up to 12 months. One hundred twelve patients per treatment arm will be enrolled in the study.
Once bone-related symptoms appear, study participation is over. During the study, the following will be assessed:
- quality of life,
- performance status,
- pain rating,
- analgesic administration and
- adverse events The principal objective is the delay in bone-related symptoms in those patients with early zoledronate administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Zoledronic acid 4 mg | Experimental | Drug: Zoledronic acidZoledronate 4 mg every 3 or 4 weeks. This arm will receive study treatment from the time of entry into the trial, until the appearance of the symptoms of bone metastases (or a maximum period of 12 months, whichever occurs first). |
| Arm B: Observation | No intervention | –Patients will not receive any treatment with bisphosphonates until the time of onset of symptoms (or a maximum period of 12 months, whichever occurs sooner). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Written informed consent.
- Age >= 18 years old.
- Metastatic breast cancer patients with lytic, sclerotic or mixed bone lesions.
- Non-symptomatic bone lesions, defined as pain absence, lack of bone complications (fracture, hypercalcemia, Central Nervous System (CNS) compression), no need of analgesic chronic administration for bone disease.
- A maximum of two chemotherapy lines for metastatic disease.
Key exclusion criteria (7 listed)
- Previous treatment with bisphosphonates or raloxifene in the 30 days prior to randomization.
- Metastasis in CNS.
- History of hypersensitivity to bisphosphonates.
- Pregnant or lactating women.
- Third chemotherapy line for metastatic disease.
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 |
|---|---|---|
| Zoledronic acidAlso: Zometa | Drug | Arm A: Zoledronic acid 4 mg |
Primary outcome
Time to first bone metastases
Time frame: Up to disease progression
The main variable of evaluation is the time until the appearance of first bone metastases.
2 secondary outcomes
Quality of life per treatment arm
Time frame: Up to disease progression
The Number of Participants Who Experienced Adverse Events (AE)
Time frame: Through study treatment
Results and safety
The study was stopped early (reason given: Low recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Click here for more information about this study: GEICAM 2001-05Link 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
Hospital Clínico Universitario de Valencia
Study Director study director
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Zoledronic acid 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 10 inclusion and 7 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: stopped early, as of the sponsor's last update on 16 Apr 2019. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: Low recruitment). Results are not available in the source record.
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?
Time to first bone metastases (time frame: Up to disease progression). 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 16 Apr 2019; AzTrials last refreshed its copy on 8 Nov 2026.