Back to resultsZometa and Circulating Vascular Endothelial Growth Factor (VEGF) in Breast Cancer Patients With Bone Metastasis
Primary Purpose
Metastatic Breast Cancer, Bone Metastases
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Zoledronic acid
Zoledronic acid
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Breast Cancer focused on measuring Breast cancer, Bone metastasis, Circulating VEGF, Zoledronic acid, Angiogenesis
Eligibility Criteria
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.
Sites / Locations
- Fudan University Cancer Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
conventional Zometa
weekly Zometa
Arm Description
Zometa 4mg IV q4w, in combination with other antitumor agents one month after the initial dosing.
Weekly Zometa in combination with other antitumor agents one month after the initial dosing.
Outcomes
Primary Outcome Measures
Circulating VEGF levels in breast cancer patients with bone metastases
Secondary Outcome Measures
Time to first skeletal-related event
Time to bone progression disease
Progression-free survival
Overall survival
Full Information
NCT ID
NCT00524849
First Posted
September 4, 2007
Last Updated
September 13, 2010
Sponsor
Fudan University
Collaborators
Novartis
1. Study Identification
Unique Protocol Identification Number
NCT00524849
Brief Title
Zometa and Circulating Vascular Endothelial Growth Factor (VEGF) in Breast Cancer Patients With Bone Metastasis
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 Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Fudan University
Collaborators
Novartis
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Breast Cancer, Bone Metastases
Keywords
Breast cancer, Bone metastasis, Circulating VEGF, Zoledronic acid, Angiogenesis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
conventional Zometa
Arm Type
Active Comparator
Arm Description
Zometa 4mg IV q4w, in combination with other antitumor agents one month after the initial dosing.
Arm Title
weekly Zometa
Arm Type
Experimental
Arm Description
Weekly Zometa in combination with other antitumor agents one month after the initial dosing.
Intervention Type
Biological
Intervention Name(s)
Zoledronic acid
Other Intervention Name(s)
Zometa
Intervention Description
Zometa 1 mg weekly (intravenous)
Intervention Type
Drug
Intervention Name(s)
Zoledronic acid
Intervention Description
Zometa 4 mg every four weeks (intravenous)
Primary Outcome Measure Information:
Title
Circulating VEGF levels in breast cancer patients with bone metastases
Time Frame
one month
Secondary Outcome Measure Information:
Title
Time to first skeletal-related event
Time Frame
3 years
Title
Time to bone progression disease
Time Frame
3 years
Title
Progression-free survival
Time Frame
3 years
Title
Overall survival
Time Frame
3 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xichun Hu, MD, PhD
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Cancer Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
12912933
Citation
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.
Results Reference
background
PubMed Identifier
21936956
Citation
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.
Results Reference
derived
PubMed Identifier
20882405
Citation
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.
Results Reference
derived
Learn more about this trial
Zometa and Circulating Vascular Endothelial Growth Factor (VEGF) in Breast Cancer Patients With Bone Metastasis
We'll reach out to this number within 24 hrs