Metastatic Breast CancerPhase 2/3NCT00524849
Zometa and Circulating Vascular Endothelial Growth Factor (VEGF) in Breast Cancer Patients With Bone Metastasis
A Phase 2/3 study testing Zoledronic acid in people with Metastatic Breast Cancer and Bone Metastases, run by Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Metastatic Breast Cancer, Bone Metastases
- What is being tested?
- Zoledronic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Nov 2006to Jan 2010
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, 200032
About this study
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
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.
Read the 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.
- Conditions
- Metastatic Breast Cancer, Bone Metastases
- Being tested
- Zoledronic acid
- Keywords
- Breast cancer, Bone metastasis, Circulating VEGF, Zoledronic acid, Angiogenesis
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zoledronic acidBiological
Also called Zometa
Zometa 1 mg weekly (intravenous)
Zoledronic acidDrug
Zometa 4 mg every four weeks (intravenous)
| Study group | Role | What they receive |
|---|---|---|
| conventional Zometa | Active comparator | Zometa 4mg IV q4w, in combination with other antitumor agents one month after the initial dosing. Receives: Drug: Zoledronic acid |
| weekly Zometa | Experimental | Weekly Zometa in combination with other antitumor agents one month after the initial dosing. Receives: Biological: Zoledronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circulating VEGF levels in breast cancer patients with bone metastases
Measured: one month
Secondary outcomes (4)
Time to first skeletal-related event
Measured: 3 years
Time to bone progression disease
Measured: 3 years
Progression-free survival
Measured: 3 years
Overall survival
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2007 (estimated)
- Study startNov 2006
- Primary completionAug 2008
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Investigators
- Xichun Hu, MD, PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00524849
- Sponsor's protocol ID
- CZOL446ECN05
- Status last verified
- Sep 2010
- First submitted
- 4 Sep 2007
- Last updated
- 14 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 12912933Zhao 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.
PubMed 21936956Zhao 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.
PubMed 20882405
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00524849
- Acronym / sponsor ID
- CZOL446ECN05
- Conditions
- Metastatic Breast Cancer, Bone Metastases
- Keywords
- Breast cancer, Bone metastasis, Circulating VEGF, Zoledronic acid, Angiogenesis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Nov 2006
- Primary completion
- Aug 2008 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 5 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional Zometa | Active comparator | Drug: Zoledronic acidZometa 4mg IV q4w, in combination with other antitumor agents one month after the initial dosing. |
| weekly Zometa | Experimental | Biological: Zoledronic acidWeekly Zometa in combination with other antitumor agents one month after the initial dosing. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Signed informed consent
- Female, 18 years or older
- Histologically confirmed invasive breast cancer
- Bone metastases
- ECOG Performance Status of 0 to 2
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zoledronic acidAlso: ZometaZometa 1 mg weekly (intravenous) | Biological | weekly Zometa |
| Zoledronic acidZometa 4 mg every four weeks (intravenous) | Drug | conventional Zometa |
Primary outcome
Circulating VEGF levels in breast cancer patients with bone metastases
Time frame: one month
4 secondary outcomes
Time to first skeletal-related event
Time frame: 3 years
Time to bone progression disease
Time frame: 3 years
Progression-free survival
Time frame: 3 years
Overall survival
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2010.
- Background: PubMed 12912933Santini 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.
- Derived from this study: PubMed 21936956Zhao 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.
- Derived from this study: PubMed 20882405Zhao 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xichun Hu, MD, PhD principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Zoledronic acid in people with Metastatic Breast Cancer and Bone Metastases, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Circulating VEGF levels in breast cancer patients with bone metastases (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00524849, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2010.