- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01344967
Suppression of Bone Turnover Following Treatment With Zoledronic Acid in Patients With Metastatic Breast Cancer: Duration of Effect (SuBDuE)
June 22, 2015 updated by: University Health Network, Toronto
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 Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
21
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5B 1N9
- St. Michael's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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).
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Zometa, Bone Suppression, Active Ingredient
|
Zoledronic Acid at a dose of 4mg will be administered by intravenous infusion over 15 minutes in at least 100mls of saline
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Baseline to Twelve weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Baseline to Twelve weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2009
Primary Completion (Actual)
August 1, 2011
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
April 28, 2011
First Submitted That Met QC Criteria
April 28, 2011
First Posted (Estimate)
April 29, 2011
Study Record Updates
Last Update Posted (Estimate)
June 23, 2015
Last Update Submitted That Met QC Criteria
June 22, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UHN-080520C
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Metastatic Breast Cancer With Bone Involvement
-
NovartisCompletedBreast Cancer With Metastatic Bone DiseaseTurkey
-
Peking University Cancer Hospital & InstituteRecruitingHER2-positive Metastatic Breast Cancer | Previously Treated With Trastuzumab | Trastuzumab Combined With Pertuzumab and ChemotherapyChina
-
Hoffmann-La RocheCompletedMetastatic Breast CancerHungary
-
National Cancer Institute (NCI)RecruitingAnatomic Stage IV Breast Cancer AJCC v8 | Metastatic Malignant Neoplasm in the Bone | Metastatic HER2-Negative Breast CarcinomaUnited States
-
Jiangsu HengRui Medicine Co., Ltd.RecruitingTreatment in HER2-negative Metastatic Breast Cancer Patients With Germline BRCA MutationChina
-
Stony Brook UniversityThe University of Texas Health Science Center at San AntonioRecruitingMetastatic Cancer | Metastatic Lung Cancer | Metastatic Breast Cancer | Metastasis | Spine Metastases | Metastatic Tumor | Metastatic Tumor of Bone | Metastatic Tumor to the SpineUnited States
-
University of WashingtonAbbVieNo longer availableTriple-Negative Breast Cancer | Metastatic Breast Cancer With BRCA 1 or BRCA 2 Genetic MutationUnited States
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)WithdrawnStage IV Breast Cancer | Breast Carcinoma Metastatic to the BoneUnited States
-
Novartis PharmaceuticalsCompletedBreast Cancer With Bone MetastasisItaly
-
Merck Sharp & Dohme LLCCompletedBreast Cancer | Metastatic Bone Disease
Clinical Trials on Zoledronic acid
-
University of CalgaryRecruitingOsteo Arthritis Knee | Anterior Cruciate Ligament Injuries | Anterior Cruciate Ligament Rupture | Anterior Cruciate Ligament TearCanada
-
Yonsei UniversityRecruiting
-
Novartis PharmaceuticalsCompleted
-
Thomas J. SchnitzerNovartisTerminatedBone LossUnited States
-
University of CalgaryRecruitingOsteoporosis | Bone Loss | Osteopenia | Osteoporosis, PostmenopausalCanada
-
Columbia UniversityNovartis PharmaceuticalsCompletedLiver Transplantation | Heart Transplantation | Bone ResorptionUnited States
-
Toufiqe-E-EalahiRecruiting
-
Children's Hospital of Eastern OntarioWithdrawnAcute Lymphoblastic Leukemia | Osteoporosis | OsteonecrosisCanada
-
Stanford UniversityNational Institutes of Health (NIH)WithdrawnBone Marrow Transplant | Hematopoietic Stem Cell Transplant
-
Novartis PharmaceuticalsCompleted