Effect of Zoledronic Acid as Anti-Cancer Treatment in Metastatic Breast Cancer Patients
NCT ID: NCT01129336
Last Updated: 2014-05-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
44 participants
INTERVENTIONAL
2010-06-30
2012-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Patients without bone metastases
Patients with no bone metastasis were randomized into a 1:1 ratio to standard therapy plus zoledronic acid 4mg IV Zoledronic acid administration monthly during Months 1-18.
Zoledronic acid
Patients with no bone metastasis (n=150) will receive Standard therapy plus Zoledronic acid administration 4 mg IV monthly during Months 1-18.
Patients with bone metastases
Patients with bone metastasis received standard therapy + zoledronic acid for 18 months (discontinued upon disease progression/secondary malignancy)
Standard Therapy
Standard Therapy, including chemotherapy and hormonal therapy, was determined at the discretion of the investigator.
Interventions
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Zoledronic acid
Patients with no bone metastasis (n=150) will receive Standard therapy plus Zoledronic acid administration 4 mg IV monthly during Months 1-18.
Standard Therapy
Standard Therapy, including chemotherapy and hormonal therapy, was determined at the discretion of the investigator.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Female patients (age ≥18 years)
* HER2-negative metastatic breast cancer (stage IV)
* Patients will be receiving chemotherapy or hormonal therapy
* Patients with no bone metastasis and ≤1 prior treatments for metastatic breast cancer. Patients with newly diagnosed metastatic breast cancer may have received adjuvant or neoadjuvant chemotherapy as long as treatment was completed ≥12 months prior to relapse.
* Asymptomatic brain metastasis is permitted if all of the following criteria are met:
1. no sign of clinical progression or known progression of brain metastasis
2. off steroids for at least 2 weeks prior to study enrollment
* Stable renal function: two serum creatinine determinations of \<3 mg/dL, obtained no less than 7 days apart (one value may be obtained within 6 weeks prior to Screening; the second must be obtained during Screening)
* ECOG performance status of 0 or 1
* Life expectancy of ≥ 6 months
* Negative serum pregnancy test
* Ability and willingness to comply with all study requirements
Exclusion Criteria
* Patients with history of another malignancy within the last two years prior to study enrollment, except cured basal cell carcinoma of the skin or excised carcinoma in site of the cervix
* Use of concurrent investigational agents is prohibited. Prior use of investigational agents is permitted if discontinued ≥30 days prior to Screening.
* No prior therapy with an antiresorptive agent
* Patients with active brain metastases or meningeal metastases
* Current or recent (in the six months prior to initial study drug treatment) severe cardiovascular disease (defined as uncontrolled congestive heart failure), hypertension refractory to treatment, or poorly controlled Type I/II diabetes mellitus
* Current active dental problems including dental abscess or infection of the jawbone (maxilla or mandible) or a current or prior diagnosis of osteonecrosis of the jaw
* Patients who have received radiotherapy ≤ 4 weeks prior to study enrollment or who have not recovered from radiotherapy-related toxicities. Palliative radiotherapy for bone lesions ≤ 2 weeks prior to study enrollment is allowed
* Patients who have undergone major surgery (e.g., intra-thoracic, intra-abdominal or intra-pelvic) ≤ 4 weeks prior to study enrollment or who have not recovered from side effects of such therapy
* Diminished renal capacity: calculated creatinine clearance (CrCl) \<30 mL/min (based on Cockcroft-Gault formula)
* Corrected (i.e., adjusted for serum albumin) serum calcium of \<8.0 mg/dL (2.00 mmol/L) or ≥ 12 mg/dL (3.00 mmol/L)
* Pregnant or breast-feeding females
* Women of child-bearing potential who are not willing/able to use effective methods of birth control (e.g., abstinence, oral contraceptives or implants, IUD, vaginal diaphragm or sponge, or condom with spermicide)
* History of non-compliance to medical regimens and/or patients who are considered unreliable
* History of bone metabolism diseases
18 Years
FEMALE
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Highlands Oncology Group
Fayetteville, Arkansas, United States
Clopton Clinic
Jonesboro, Arkansas, United States
Hematology Oncology Services of Arkansas
Little Rock, Arkansas, United States
Kaiser Permanente Medical Group Kaiser Permanente - Hawaii
Anaheim, California, United States
Wilshire Oncology Medical Group
La Verne, California, United States
Loma Linda University Loma Linda Cancer Center
Loma Linda, California, United States
Hematology and Medical Oncology
Waterbury, Connecticut, United States
Florida Cancer Specialists DeptofFloridaCancerSpecialists
Fort Myers, Florida, United States
Lakeland Regional Cancer Center Dept. of Lakeland Regional
Lakeland, Florida, United States
Space Coast Medical Associates
Titusville, Florida, United States
Kootenai Medical Center Kootenai Medical Center
Coeur d'Alene, Idaho, United States
Oncology Specialists, SC Lutheran General Cancer Instit
Park Ridge, Illinois, United States
Cancer Center of Kansas
Witchita, Kansas, United States
Park Nicollet Institute Dept. of Park Nicollet
Saint Louis Park, Minnesota, United States
St. John's Mercy Medical Center St. John's Mercy Med Ctr
St Louis, Missouri, United States
Hematology Oncology Centers of the Northern Rockies Hema Onc Ctr N. Rockies (4
Billings, Montana, United States
Southeast Nebraska Oncology Cancer Center
Lincoln, Nebraska, United States
Reno Oncology Consultants
Reno, Nevada, United States
Somerset Hematology Oncology Associates Somerset Hema Oncol Assoc (2)
Somerset, New Jersey, United States
Cooper Cancer Center
Voorhees Township, New Jersey, United States
NYU Langone Arena Oncology
Lake Success, New York, United States
Marion L. Shepard Cancer Center
Washington, North Carolina, United States
Piedmont Hematology and Oncology Associates Piedmont Hem/Onc Assoc (2)
Winston-Salem, North Carolina, United States
Hematology Oncology Center, Inc.
Elyria, Ohio, United States
Milton S Hershey Medical Center Hershey Medical Center (4)
Hershey, Pennsylvania, United States
Berks Hematology Oncology
West Reading, Pennsylvania, United States
Abington Hematology Oncology Associates, Inc
Willow Grove, Pennsylvania, United States
The West Clinic
Memphis, Tennessee, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
South Texas Oncology and Hematology, PA South Texas Oncology (2)
San Antonio, Texas, United States
East Texas Medical Center Cancer Institute Tyler Hem/Onc (3)
Tyler, Texas, United States
Medical Oncology & Hematology Associates of Northern VA Med. Onc&Hem Assoc. of No.VA
Reston, Virginia, United States
Northwest Medical Specialties
Tacoma, Washington, United States
Countries
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Related Links
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Related Info
Other Identifiers
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CZOL446EUS147
Identifier Type: -
Identifier Source: org_study_id
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