Breast CancerPhase 1/2NCT00060138
Monoclonal Antibody Compared With Zoledronate in Treating Women With Breast Cancer and Bone Metastases
A Phase 1/2 study testing monoclonal antibody CAL and zoledronic acid in people with Breast Cancer and Hypercalcemia of Malignancy, run by Chugai Pharmaceutical at 1 site in United States.
Trial summary
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Zoledronate may prevent bone loss and stop the growth of tumor cells in bone. 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?
- monoclonal antibody CAL and zoledronic acid
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Nov 2002to Sep 2004
- Phase
- Phase 1/2
- 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 or cytologically confirmed breast cancer
- Radiographical evidence of at least 1 bone metastasis
- No prior radiotherapy or surgery to bone metastasis
- No radiotherapy or surgery anticipated for bone metastasis within the next 24 weeks
- Bone pain severity score of at least 1 on 5 of 7 days as determined by question 3 of the Brief Pain Inventory (BPI)
- No bone metastases to a weight-bearing bone at imminent risk for pathologic fracture or surgical intervention
- No vertebral metastases that place the patient at imminent risk of spinal cord compression
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age
- 18 and over
Sex
- Female
Menopausal status
- Pre- or post-menopausal
Performance status
- ECOG 0-2
Life expectancy
- At least 6 months
Hematopoietic
- WBC at least 2,000/mm^3
- Lymphocyte count at least 500/mm^3
- Granulocyte count at least 1,000/mm^3
- Platelet count at least 50,000/mm^3
Hepatic
- ALT or AST no greater than 2.5 times upper limit of normal (ULN)
- Bilirubin no greater than 1.5 times ULN
Renal
- Calcium no greater than 10.1 mg/dL
- No oliguria, defined as less than 30 mL urine per 2-hour collection
- No acute renal failure
- Creatinine no greater than 2.5 mg/dL
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception
- No sepsis
- No known or anticipated contraindication to study drugs
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- More than 3 weeks since initiation of a new chemotherapy regimen
Endocrine therapy
- More than 3 weeks since initiation of a new hormonal therapy regimen
Radiotherapy
- See Disease Characteristics
- More than 3 weeks since prior radiotherapy
Surgery
- See Disease Characteristics
Other
- More than 60 days since prior bisphosphonates
- More than 30 days since prior investigational drugs
- No change in analgesic drug regimen during the screening period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I-II, 24-Week, Multi-Center, Double-Blind, Randomized, Dose-Ranging Study To Evaluate The Safety And Efficacy Of A Humanized Monoclonal Antibody To PTHrP Versus Zoledronic Acid In Patients With Breast Cancer Metastatic To Bone
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Zoledronate may prevent bone loss and stop the growth of tumor cells in bone. It is not yet known whether monoclonal antibody is more effective than zoledronate in treating women who have breast cancer and bone metastases.
PURPOSE: Randomized phase I/II trial to compare the effectiveness of monoclonal antibody with that of zoledronate in treating women who have breast cancer and bone metastases.
Read the detailed description
OBJECTIVES:
- Compare the safety and tolerability of monoclonal antibody CAL vs zoledronate in women with breast cancer and bone metastases.
- Compare, preliminarily, the potential effects of these drugs on skeletal events/manifestations related to bone metastases, including hypercalcemia, bone pain, bone metastatic lesions, complications (e.g., pathologic fracture and spinal cord compression), and interventions (e.g., surgery and radiotherapy) in these patients.
- Compare changes in ECOG performance status in patients treated with these drugs.
- Determine the pharmacokinetics of monoclonal antibody CAL in these patients.
OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to average prestudy pain score on question 3 of a daily electronic telephone pain diary (less than 3 vs 3 or more) and prior bisphosphonate therapy (yes vs no). Patients are randomized to 1 of 4 treatment arms.
- Arm I: Patients receive monoclonal antibody CAL IV over 30-60 minutes on day 1.
- Arm II: Patients receive a lower dose of monoclonal antibody CAL as in arm I.
- Arm III: Patients receive a lower dose (lower than arm II) of monoclonal antibody CAL as in arm I.
- Arm IV: Patients receive zoledronate IV over 30-60 minutes on day 1. Treatment in all arms repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Patients keep a pain diary throughout study participation.
Patients are followed at 24 weeks.
PROJECTED ACCRUAL: A total of 72 patients (18 per treatment arm) will be accrued for this study.
- Conditions
- Breast Cancer, Hypercalcemia of Malignancy, Metastatic Cancer, Pain
- Being tested
- monoclonal antibody CAL, zoledronic acid
- Keywords
- hypercalcemia of malignancy, stage IV breast cancer, recurrent breast cancer, bone metastases, pain
- 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.
monoclonal antibody CALBiological
zoledronic acidDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2003 (estimated)
- Study startNov 2002
- Primary completionSep 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 1/2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Chugai Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Paula Silverman, MD, Study chair, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00060138
- Sponsor's protocol ID
- CWRU-080235
- Other IDs
- CDR0000299530, CBI-1102, CBI-CAL-03
- Status last verified
- May 2013
- First submitted
- 6 May 2003
- Last updated
- 15 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I-II, 24-Week, Multi-Center, Double-Blind, Randomized, Dose-Ranging Study To Evaluate The Safety And Efficacy Of A Humanized Monoclonal Antibody To PTHrP Versus Zoledronic Acid In Patients With Breast Cancer Metastatic To Bone
- ClinicalTrials.gov ID
- NCT00060138
- Acronym / sponsor ID
- CWRU-080235
- Conditions
- Breast Cancer, Hypercalcemia of Malignancy, Metastatic Cancer, Pain
- Keywords
- hypercalcemia of malignancy, stage IV breast cancer, recurrent breast cancer, bone metastases, pain
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Chugai PharmaceuticalIndustry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2002
- Primary completion
- Sep 2004 (actual)
- First posted
- 7 May 2003 (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: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Zoledronate may prevent bone loss and stop the growth of tumor cells in bone. It is not yet known whether monoclonal antibody is more effective than zoledronate in treating women who have breast cancer and bone metastases.
PURPOSE: Randomized phase I/II trial to compare the effectiveness of monoclonal antibody with that of zoledronate in treating women who have breast cancer and bone metastases.
Detailed description
OBJECTIVES:
- Compare the safety and tolerability of monoclonal antibody CAL vs zoledronate in women with breast cancer and bone metastases.
- Compare, preliminarily, the potential effects of these drugs on skeletal events/manifestations related to bone metastases, including hypercalcemia, bone pain, bone metastatic lesions, complications (e.g., pathologic fracture and spinal cord compression), and interventions (e.g., surgery and radiotherapy) in these patients.
- Compare changes in ECOG performance status in patients treated with these drugs.
- Determine the pharmacokinetics of monoclonal antibody CAL in these patients.
OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to average prestudy pain score on question 3 of a daily electronic telephone pain diary (less than 3 vs 3 or more) and prior bisphosphonate therapy (yes vs no). Patients are randomized to 1 of 4 treatment arms.
- Arm I: Patients receive monoclonal antibody CAL IV over 30-60 minutes on day 1.
- Arm II: Patients receive a lower dose of monoclonal antibody CAL as in arm I.
- Arm III: Patients receive a lower dose (lower than arm II) of monoclonal antibody CAL as in arm I.
- Arm IV: Patients receive zoledronate IV over 30-60 minutes on day 1. Treatment in all arms repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Patients keep a pain diary throughout study participation.
Patients are followed at 24 weeks.
PROJECTED ACCRUAL: A total of 72 patients (18 per treatment arm) will be accrued for this study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Masking
- Double blind
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 |
|---|---|---|
| monoclonal antibody CAL | Biological | – |
| zoledronic acid | Drug | – |
Primary outcome
Not reported in the source record.
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 15 May 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.
Paula Silverman, MD study chair
Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing monoclonal antibody CAL and zoledronic acid in people with Breast Cancer and Hypercalcemia of Malignancy, run by Chugai Pharmaceutical at 1 site in United States.
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: finished, as of the sponsor's last update on 15 May 2013. 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 United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
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 15 May 2013.