Zometa and Circulating Vascular Endothelial Growth Factor (VEGF) in Breast Cancer Patients With Bone Metastasis
NCT ID: NCT00524849
Last Updated: 2010-09-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
60 participants
INTERVENTIONAL
2006-11-30
2010-01-31
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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conventional Zometa
Zometa 4mg IV q4w, in combination with other antitumor agents one month after the initial dosing.
Zoledronic acid
Zometa 4 mg every four weeks (intravenous)
weekly Zometa
Weekly Zometa in combination with other antitumor agents one month after the initial dosing.
Zoledronic acid
Zometa 1 mg weekly (intravenous)
Interventions
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Zoledronic acid
Zometa 1 mg weekly (intravenous)
Zoledronic acid
Zometa 4 mg every four weeks (intravenous)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Female, 18 years or older
* Histologically confirmed invasive breast cancer
* Bone metastases
* ECOG Performance Status of 0 to 2
* Life expectancy of more than 3 months
* Subject must have adequate organ function:
* Cr ≤ 3 mg/dL (265 µmol/L)，
* CrCl (Cockcroft \& Gault) ≥ 30 mL/min，
* Ca2+ \> 8.0 mg/dL (2.0 mmol/L) and ≤ 12 mg/dL (3.0 mmol/L)
* Negative serum pregnancy test for women with childbearing potential
* Good conditions for infusion and willing to undergo phlebotomy during the whole study
* Have ceased anti-tumor treatment including chemotherapy, endocrinotherapy and bio-targeted therapy for over 28 days
Exclusion Criteria
* History of other malignancy. However, subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.
* Concurrent disease or condition that would make the subject inappropriate for study participation, or any serious medical disorder that would interfere with the subject's safety
* Active or uncontrolled infection
* Current active dental problems including infection of the teeth or jawbone (maxilla or mandible); dental or fixture trauma; or a current or prior diagnosis of osteonecrosis of the jaw (ONJ); or exposed bone in the mouth; or slow healing after dental procedures
* Recent (within 6 weeks of Randomization) or planned dental or jaw surgery (e.g. extraction, implants)
* Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure
* Concomitant with liver, brain or symptomatic lung metastases (symptoms such as hemoptysis, severe cough and shortness of breath)
* Accepted radiotherapy for solitary bone disease within 30 days before study
* Previous treatment with other bisphosphonates or radionuclides within one month before study
* Known hypersensitivity to bisphosphonates
* History of treatment with calcitonin, gallium nitrate or mithracin within 14 days before study.
18 Years
75 Years
FEMALE
No
Sponsors
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Novartis
INDUSTRY
Fudan University
OTHER
Responsible Party
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Fudan University Cancer Hospital
Principal Investigators
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Xichun Hu, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China
Countries
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References
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Santini D, Vincenzi B, Dicuonzo G, Avvisati G, Massacesi C, Battistoni F, Gavasci M, Rocci L, Tirindelli MC, Altomare V, Tocchini M, Bonsignori M, Tonini G. Zoledronic acid induces significant and long-lasting modifications of circulating angiogenic factors in cancer patients. Clin Cancer Res. 2003 Aug 1;9(8):2893-7.
Zhao X, Xu X, Zhang Q, Jia Z, Sun S, Zhang J, Wang B, Wang Z, Hu X. Prognostic and predictive value of clinical and biochemical factors in breast cancer patients with bone metastases receiving "metronomic" zoledronic acid. BMC Cancer. 2011 Sep 22;11:403. doi: 10.1186/1471-2407-11-403.
Zhao X, Xu X, Guo L, Ragaz J, Guo H, Wu J, Shao Z, Zhu J, Guo X, Chen J, Zhu B, Wang Z, Hu X. Biomarker alterations with metronomic use of low-dose zoledronic acid for breast cancer patients with bone metastases and potential clinical significance. Breast Cancer Res Treat. 2010 Dec;124(3):733-43. doi: 10.1007/s10549-010-1183-6. Epub 2010 Sep 30.
Other Identifiers
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CZOL446ECN05
Identifier Type: -
Identifier Source: org_study_id