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Randomized Phase 2 Study on the Relationship Between Circulating VEGF and Weekly or Every-four-week Zometa in Breast Cancer Patients With Bone Metastases

Phase 2/Phase 3
18 Years
75 Years
Not Enrolling
Metastatic Breast Cancer, Bone Metastases

Thank you

Trial Information

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 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.

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

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Circulating VEGF levels in breast cancer patients with bone metastases

Outcome Time Frame:

one month

Safety Issue:


Principal Investigator

Xichun Hu, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fudan University


China: Ethics Committee

Study ID:




Start Date:

November 2006

Completion Date:

January 2010

Related Keywords:

  • Metastatic Breast Cancer
  • Bone Metastases
  • Breast cancer
  • Bone metastasis
  • Circulating VEGF
  • Zoledronic acid
  • Angiogenesis
  • Breast Neoplasms
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Bone Neoplasms
  • Bone Marrow Diseases