Metastatic Breast Cancer With Bone InvolvementPhase 2/3SuBDuENCT01344967
Suppression of Bone Turnover Following Treatment With Zoledronic Acid in Patients With Metastatic Breast Cancer: Duration of Effect
A Phase 2/3 study testing Zoledronic acid in people with Metastatic Breast Cancer With Bone Involvement, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Bone is the most common site of spread of breast cancer and bone metastases will occur in roughly 70% of women with advanced disease. These patients are at risk of developing bone complications that cause significant impact on both patient morbidity and mortality. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer With Bone Involvement
- What is being tested?
- Zoledronic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2009to Dec 2011
- Phase
- Phase 2/3
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have histologically confirmed breast cancer.
- Radiological or pathological evidence of bone metastases. (positive bone scan, MRI, or CT or pathological fracture, or pathological sample from bone biopsy showing evidence of metastatic breast cancer).
- Patient has not yet started on BP therapy for metastatic breast cancer to bone.
- Renal (serum creatinine, BUN), hepatic (AST, ALT, Bilirubin) function within the institutional normal range as assessed within 1 month of study entry.
- Age >/= 18 years.
- Karnofsky performance status ≥ 50.
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- Life expectancy > 6 months.
- Ability to understand and the willingness to sign a written informed consent document.
- Patients may receive any chemotherapy, biological or endocrine treatment considered appropriate by the treating physician. This can be changed during the course of the study as clinically indicated.
- Patients may be on another clinical trial, if allowed by the Trial Steering Committee for that trial.
- Patients are willing to take calcium and vitamin D supplements as recommended, while on study.
Who cannot join
- Hypersensitivity or known allergy to bisphosphonates.
- Patient currently taking Bisphosphonate therapy for metastatic breast cancer to bone (Clodronate, Pamidronate, Zoledronic Acid, Ibandronate, Calcitonin). Bisphosphonates for the treatment of other bone disease (osteoporosis, osteopenia, Paget's disease, etc) but not Zoledronic Acid, are permitted.
- Acute or chronic renal insufficiency.
- Hypocalcemia as defined by serum calcium less than institutional normal range.
- Evidence of infection/abscess on dental exam or recent dental extraction (within last 4 weeks), or presence of osteonecrosis of the jaw.
- Acute pathological fracture, spinal cord compression, or hypercalcemia requiring urgent treatment (patient may enter study after acute issues are resolved).
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- Patients with baseline hypocalcemia.
- Patients who have received ZA for prevention of breast cancer treatment-induced osteopenia or osteoporosis within the last 1 year.
- History and/or electrocardiographic evidence of atrial fibrillation.
- Pregnancy or lactation.
Trial locations and contacts
1 site in 1 country.
About this study
Bone is the most common site of spread of breast cancer and bone metastases will occur in roughly 70% of women with advanced disease. These patients are at risk of developing bone complications that cause significant impact on both patient morbidity and mortality. Close to two-thirds of women with bone metastases will go on to develop at least one of these complications, termed a skeletal related event (SRE), defined as 1) pathological fractures, 2) pain requiring radiation or surgical intervention, 3)spinal cord compression, and 4) hypercalcemia. In addition to SREs, most breast cancer patients with bone metastases have some degree of pain associated with their disease. Understandably these factors negatively impact their quality of life. Furthermore, the development of an SRE in this population has been shown to be associated with shorter overall survival. Prevention or delay in onset of these complications is therefore an important therapeutic goal.
- Being tested
- Zoledronic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zoledronic acidDrug
Also called Control No. 110322
Zoledronic Acid at a dose of 4mg will be administered by intravenous infusion over 15 minutes in at least 100mls of saline
| Study group | Role | What they receive |
|---|---|---|
| Zometa, Bone Suppression, Active Ingredient | Experimental | Not described Receives: Drug: Zoledronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study is to estimate the proportion of patients with suppression of bone turnover at 12 weeks after administration of a single dose of Zoledronic Acid
Measured: Baseline to Twelve weeks
Secondary outcomes (1)
To estimate the distribution of duration of suppression of bone turnover up to 12 weeks after administration of Zoledronic Acid
Measured: Baseline to Twelve weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2011 (estimated)
- Study startFeb 2009
- Primary completionAug 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast Cancer With Bone InvolvementStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Breast Cancer Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01344967
- Sponsor's protocol ID
- UHN-080520C
- Acronym
- SuBDuE
- Status last verified
- Jun 2015
- First submitted
- 28 Apr 2011
- Last updated
- 23 Jun 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suppression of Bone Turnover Following Treatment With Zoledronic Acid in Patients With Metastatic Breast Cancer: Duration of Effect
- ClinicalTrials.gov ID
- NCT01344967
- Acronym / sponsor ID
- SuBDuE / UHN-080520C
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Canadian Breast Cancer Foundation
- Study start
- Feb 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 29 Apr 2011 (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.
Bone is the most common site of spread of breast cancer and bone metastases will occur in roughly 70% of women with advanced disease. These patients are at risk of developing bone complications that cause significant impact on both patient morbidity and mortality. Close to two-thirds of women with bone metastases will go on to develop at least one of these complications, termed a skeletal related event (SRE), defined as 1) pathological fractures, 2) pain requiring radiation or surgical intervention, 3)spinal cord compression, and 4) hypercalcemia. In addition to SREs, most breast cancer patients with bone metastases have some degree of pain associated with their disease. Understandably these factors negatively impact their quality of life. Furthermore, the development of an SRE in this population has been shown to be associated with shorter overall survival. Prevention or delay in onset of these complications is therefore an important therapeutic goal.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zometa, Bone Suppression, Active Ingredient | Experimental | Drug: Zoledronic acid |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients must have histologically confirmed breast cancer.
- Radiological or pathological evidence of bone metastases. (positive bone scan, MRI, or CT or pathological fracture, or pathological sample from bone biopsy showing evidence of metastatic breast cancer).
- Patient has not yet started on BP therapy for metastatic breast cancer to bone.
- Renal (serum creatinine, BUN), hepatic (AST, ALT, Bilirubin) function within the institutional normal range as assessed within 1 month of study entry.
- Age >/= 18 years.
Key exclusion criteria (10 listed)
- Hypersensitivity or known allergy to bisphosphonates.
- Patient currently taking Bisphosphonate therapy for metastatic breast cancer to bone (Clodronate, Pamidronate, Zoledronic Acid, Ibandronate, Calcitonin). Bisphosphonates for the treatment of other bone disease (osteoporosis, osteopenia, Paget's disease, etc) but not Zoledronic Acid, are permitted.
- Acute or chronic renal insufficiency.
- Hypocalcemia as defined by serum calcium less than institutional normal range.
- Evidence of infection/abscess on dental exam or recent dental extraction (within last 4 weeks), or presence of osteonecrosis of the jaw.
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: Control No. 110322Zoledronic Acid at a dose of 4mg will be administered by intravenous infusion over 15 minutes in at least 100mls of saline | Drug | Zometa, Bone Suppression, Active Ingredient |
Primary outcome
The primary objective of this study is to estimate the proportion of patients with suppression of bone turnover at 12 weeks after administration of a single dose of Zoledronic Acid
Time frame: Baseline to Twelve weeks
1 secondary outcome
To estimate the distribution of duration of suppression of bone turnover up to 12 weeks after administration of Zoledronic Acid
Time frame: Baseline to Twelve weeks
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 23 Jun 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Zoledronic acid in people with Metastatic Breast Cancer With Bone Involvement, run by University Health Network, Toronto at 1 site in Canada.
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 11 inclusion and 10 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 23 Jun 2015. 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 Canada. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 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?
The primary objective of this study is to estimate the proportion of patients with suppression of bone turnover at 12 weeks after administration of a single dose of Zoledronic Acid (time frame: Baseline to Twelve weeks). 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 23 Jun 2015.