Breast CancerPhase 3NCT00301886
S0308 Zoledronate or Ibandronate in Preventing Bone Problems in Women With Stage IV Breast Cancer That Has Spread to the Bone
A Phase 3 study testing ibandronate, zoledronate and quality-of-life assessment in people with Breast Cancer and Hypercalcemia of Malignancy, run by SWOG Cancer Research Network.
Trial summary
RATIONALE: Zoledronate and ibandronate may prevent or help relieve bone pain and other symptoms caused by bone metastases. It is not yet known whether zoledronate is more effective than ibandronate in preventing bone problems caused by bone metastases due to breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Hypercalcemia of Malignancy, Metastatic Cancer
- What is being tested?
- ibandronate, zoledronate and quality-of-life assessment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2006to May 2006
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed stage IV breast cancer at primary diagnosis or at recurrence
- Any T, any N, M1
- At least 1 dominant osteolytic or osteoblastic or mixed metastatic lesion outside any prior radiation field
- Lesion measures ≥ 1.0 cm by x-ray, CT scan, and/or MRI
- Controlled asymptomatic brain metastases allowed
- Controlled bone pain, defined as a physician/health care provider rating of ≤ grade 2 pain-SELECT (Bone) on the NCI CTC for Adverse Events Version 3.0 rating scale, required
- Current evidence of vertebral or nonvertebral fractures or spinal compression due to cancer, as determined by the treating physician, allowed
- No Paget's disease of the bone
- Estrogen receptor (ER) or progesterone receptor (PR) status known
PATIENT CHARACTERISTICS:
- Female patient
- Menopausal status not specified
- Zubrod performance status 0-2
- Creatinine normal
- Creatinine clearance ≥ 60 mL/min
- Serum calcium < 12 mg/dL
- Not pregnant or nursing
- Fertile patients must use effective contraception
- Must be able to receive IV medication and oral medication (i.e., must have physical integrity of the upper gastrointestinal tract)
- No malabsorption syndrome
- No primary hyperparathyroidism
- No known history of aspirin-sensitive asthma
- No other prior malignancy except for the following:
- Adequately treated basal cell or squamous cell skin cancer
- In situ cervical cancer
- Adequately treated stage I or II cancer currently in complete remission
- Any other cancer for which the patient has been disease-free for at least 5 years
- No uncontrolled medical illness or infection, including, but not limited to, the following:
- Unstable angina
- Recent myocardial infarction
- Life-threatening cardiac arrhythmia
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior bisphosphonates for metastatic bone disease
- More than 28 days since prior aminoglycoside antibiotics
- At least 28 days since prior oral bisphosphonates for osteoporosis
- More than 6 months since prior bisphosphonates used for adjuvant therapy
- Concurrent treatment, including chemotherapy, hormonal therapy, and/or biologic therapy for metastatic breast cancer allowed
- No concurrent participation in another clinical treatment trial for this cancer unless the patient is no longer receiving the intervention and is in the follow-up phase of the other clinical trial
About this study
Official title: A Phase III Randomized, Multicenter Non-Inferiority Trial Evaluating the Efficacy of Oral Ibandronate Versus Intravenous Zoledronate in the Reduction of Skeletal-Related Events in Patients With Metastatic Breast Cancer
RATIONALE: Zoledronate and ibandronate may prevent or help relieve bone pain and other symptoms caused by bone metastases. It is not yet known whether zoledronate is more effective than ibandronate in preventing bone problems caused by bone metastases due to breast cancer.
PURPOSE: This randomized phase III trial is studying zoledronate to see how well it works compared to ibandronate in preventing bone problems in women with stage IV breast cancer that has spread to the bone.
Read the detailed description
OBJECTIVES:
Primary
- Compare the efficacy of zoledronate vs ibandronate, in terms of preventing the occurrence of skeletal-related events (SRE) (e.g., fracture, spinal cord compression, radiotherapy or surgery for bone symptoms or events, or hypercalcemia ≥ grade 3), in women with stage IV breast cancer and bone metastases.
Secondary
- Compare the change in patient-reported measures of pain and use of analgesics in patients treated with these drugs.
- Compare the time to first clinically apparent SRE in patients treated with these drugs.
- Compare the toxicity of these drugs.
- Compare the changes in performance status and overall survival of patients treated with these drugs.
OUTLINE: This is a multicenter, randomized study. Patients are stratified according to hormone receptor status (estrogen receptor [ER] and progesterone receptor [PR] negative vs ER and/or PR positive) and current evidence of fracture (vertebral or nonvertebral) or spinal compression (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral ibandronate once daily on days 1-28.
- Arm II: Patients receive zoledronate IV over 15 minutes on day 1. In both arms, treatment repeats every 28 days for up to 18 courses in the absence of unacceptable toxicity.
Quality of life and pain are assessed at baseline, every 3 courses during study treatment, and at the end of study treatment.
After completion of study treatment, patients are followed periodically for up to 3 years.
PROJECTED ACCRUAL: A total of 488 patients will be accrued for this study.
- Conditions
- Breast Cancer, Hypercalcemia of Malignancy, Metastatic Cancer, Pain
- Being tested
- ibandronate, zoledronate, quality-of-life assessment
- Keywords
- pain, hypercalcemia of malignancy, stage IV breast cancer, bone metastases, recurrent breast cancer
- Medical subject headings
- Breast Neoplasms, Humoral Hypercalcemia Of Malignancy, Neoplasm Metastasis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ibandronateDrug
Also called ibandronate sodium
zoledronateDrug
Also called zoledronic acid
quality-of-life assessmentProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| zoledronate | Experimental | zoledronate Receives: Drug: zoledronate; Procedure: quality-of-life assessment |
| ibandronate | Experimental | ibandronate Receives: Drug: ibandronate; Procedure: quality-of-life assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skeletal-related events (SRE)
Secondary outcomes (4)
Change in patient's rating of worst pain as measured by the Brief Pain Inventory
Survival and time to first clinically apparent SRE
Tolerability and toxicity as measured by NCI CTCAE v3.0
Changes in performance status
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2006 (estimated)
- Study startMay 2006
- Primary completionMay 2006
- Study completionMay 2006
Why it stopped: withdrawn support for study
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.
- More trials run by SWOG Cancer Research NetworkThe 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- SWOG Cancer Research Network
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Saul E. Rivkin, MD, Study chair, Swedish Cancer Institute at Swedish Medical Center - First Hill CampusKathy S. Albain, MD, Study chair, Loyola UniversityDawn Hershman, MD, Study chair, Herbert Irving Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00301886
- Sponsor's protocol ID
- CDR0000463758
- Other IDs
- S0308, U10CA037429
- Status last verified
- Nov 2013
- First submitted
- 9 Mar 2006
- Last updated
- 13 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized, Multicenter Non-Inferiority Trial Evaluating the Efficacy of Oral Ibandronate Versus Intravenous Zoledronate in the Reduction of Skeletal-Related Events in Patients With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00301886
- Acronym / sponsor ID
- CDR0000463758
- Conditions
- Breast Cancer, Hypercalcemia of Malignancy, Metastatic Cancer, Pain
- Keywords
- pain, hypercalcemia of malignancy, stage IV breast cancer, bone metastases, recurrent breast cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: withdrawn support for study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- SWOG Cancer Research NetworkResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2006
- Primary completion
- May 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 13 Mar 2006 (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.
RATIONALE: Zoledronate and ibandronate may prevent or help relieve bone pain and other symptoms caused by bone metastases. It is not yet known whether zoledronate is more effective than ibandronate in preventing bone problems caused by bone metastases due to breast cancer.
PURPOSE: This randomized phase III trial is studying zoledronate to see how well it works compared to ibandronate in preventing bone problems in women with stage IV breast cancer that has spread to the bone.
Detailed description
OBJECTIVES:
Primary
- Compare the efficacy of zoledronate vs ibandronate, in terms of preventing the occurrence of skeletal-related events (SRE) (e.g., fracture, spinal cord compression, radiotherapy or surgery for bone symptoms or events, or hypercalcemia ≥ grade 3), in women with stage IV breast cancer and bone metastases.
Secondary
- Compare the change in patient-reported measures of pain and use of analgesics in patients treated with these drugs.
- Compare the time to first clinically apparent SRE in patients treated with these drugs.
- Compare the toxicity of these drugs.
- Compare the changes in performance status and overall survival of patients treated with these drugs.
OUTLINE: This is a multicenter, randomized study. Patients are stratified according to hormone receptor status (estrogen receptor [ER] and progesterone receptor [PR] negative vs ER and/or PR positive) and current evidence of fracture (vertebral or nonvertebral) or spinal compression (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral ibandronate once daily on days 1-28.
- Arm II: Patients receive zoledronate IV over 15 minutes on day 1. In both arms, treatment repeats every 28 days for up to 18 courses in the absence of unacceptable toxicity.
Quality of life and pain are assessed at baseline, every 3 courses during study treatment, and at the end of study treatment.
After completion of study treatment, patients are followed periodically for up to 3 years.
PROJECTED ACCRUAL: A total of 488 patients will be accrued for this study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| zoledronate | Experimental | Drug: zoledronate, Procedure: quality-of-life assessmentzoledronate |
| ibandronate | Experimental | Drug: ibandronate, Procedure: quality-of-life assessmentibandronate |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| ibandronateAlso: ibandronate sodium | Drug | ibandronate |
| zoledronateAlso: zoledronic acid | Drug | zoledronate |
| quality-of-life assessment | Procedure or surgery | ibandronate, zoledronate |
Primary outcome
Skeletal-related events (SRE)
4 secondary outcomes
Change in patient's rating of worst pain as measured by the Brief Pain Inventory
Survival and time to first clinically apparent SRE
Tolerability and toxicity as measured by NCI CTCAE v3.0
Changes in performance status
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2013.
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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.
Saul E. Rivkin, MD study chair
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Kathy S. Albain, MD study chair
Loyola University
Dawn Hershman, MD study chair
Herbert Irving Comprehensive Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ibandronate, zoledronate and quality-of-life assessment in people with Breast Cancer and Hypercalcemia of Malignancy, run by SWOG Cancer Research Network.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: withdrawn, as of the sponsor's last update on 13 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
Skeletal-related events (SRE). 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 13 Nov 2013.