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Zometa and Circulating Vascular Endothelial Growth Factor (VEGF) in Breast Cancer Patients With Bone Metastasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00524849
Recruitment Status : Completed
First Posted : September 5, 2007
Last Update Posted : September 14, 2010
Information provided by:
Fudan University

Brief Summary:
The primary objective of this study is to evaluate the effects of Zometa (zoledronic acid, 1 mg per week versus 4 mg every four weeks) on the circulating vascular endothelial growth factor (VEGF) levels in breast cancer patients with bone metastases. Sixty patients will be randomized into two groups.

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Bone Metastases Biological: Zoledronic acid Drug: Zoledronic acid Phase 2 Phase 3

Detailed Description:
The administration of Zometa in short intervals has been implied to be more potent in maximizing its antitumor and antiangiogenesis effects, while dosing every four weeks is an appropriate strategy for the prevention and management of bone metastases. This study was designed to explore the relationship between dosing of Zometa and level of circulating VEGF.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase 2 Study on the Relationship Between Circulating VEGF and Weekly or Every-four-week Zometa in Breast Cancer Patients With Bone Metastases
Study Start Date : November 2006
Actual Primary Completion Date : August 2008
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Active Comparator: conventional Zometa
Zometa 4mg IV q4w, in combination with other antitumor agents one month after the initial dosing.
Drug: Zoledronic acid
Zometa 4 mg every four weeks (intravenous)

Experimental: weekly Zometa
Weekly Zometa in combination with other antitumor agents one month after the initial dosing.
Biological: Zoledronic acid
Zometa 1 mg weekly (intravenous)
Other Name: Zometa

Primary Outcome Measures :
  1. Circulating VEGF levels in breast cancer patients with bone metastases [ Time Frame: one month ]

Secondary Outcome Measures :
  1. Time to first skeletal-related event [ Time Frame: 3 years ]
  2. Time to bone progression disease [ Time Frame: 3 years ]
  3. Progression-free survival [ Time Frame: 3 years ]
  4. Overall survival [ Time Frame: 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Signed informed consent
  • 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:

  • Pregnant or lactating females
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00524849

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China, Shanghai
Fudan University Cancer Hospital
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Fudan University
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Principal Investigator: Xichun Hu, MD, PhD Fudan University
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Xichun Hu/Dr., Fudan University Cancer Hospital Identifier: NCT00524849    
Other Study ID Numbers: CZOL446ECN05
First Posted: September 5, 2007    Key Record Dates
Last Update Posted: September 14, 2010
Last Verified: September 2010
Keywords provided by Fudan University:
Breast cancer
Bone metastasis
Circulating VEGF
Zoledronic acid
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Bone Neoplasms
Bone Marrow Diseases
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases
Zoledronic Acid
Bone Density Conservation Agents
Physiological Effects of Drugs