NCT00811369

Trial to Evaluate the Therapeutic Benefit of Fulvestrant in Combination With ZACTIMA in Postmenopausal Women With Bone Predominant, Hormone Receptor Positive Metastatic Breast Cancer

A Phase II, Multi-Centre, Randomized, Double-blind Trial to Evaluate the Therapeutic Benefit of Fulvestrant in Combination With ZACTIMA or Fulvestrant Plus Placebo in Postmenopausal Women With Bone Only or Bone Predominant, Hormone Receptor Positive Metastatic Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: Ontario Clinical Oncology Group (OCOG) · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate whether the combination of fulvestrant and ZACTIMA, versus fulvestrant plus placebo, results in a significant decrease in the bone marker, urinary N-Telopeptide (NTx) in postmenopausal women with bone only, or bone predominant, hormone receptor-positive metastatic breast cancer. A significant decrease will be defined as a \> 30% reduction in urinary NTx level from baseline.

Detailed description

Tumor angiogenesis is associated with invasiveness and the metastatic potential of various cancers. Vascular endothelial growth factor (VEGF), the most potent and specific angiogenic factor, regulates normal and pathologic angiogenesis. The increased expression of VEGF has been correlated with metastases, recurrence and poor prognosis in many cancers. It has been shown the VEGF is involved in osteolysis in women with bone metastases. ZACTIMA is an agent which targets VEGF. ZACTIMA is a new agent with novel method of action - it is a VEGF inhibitor, epidermal growth factor (EGFR) inhibitor, tyrosine kinase inhibitor, as well as a potential RET kinase activity inhibitor. In summary, women with bone only, or bone predominant, metastatic breast cancer is an ideal group to study anti-angiogenic therapies where angiogenesis could be a major factor in tumor progression and where anti-angiogenic treatment with agents like ZACTIMA could be more effective.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Fulvestrant + ZACTIMA	ZACTIMA 100 mg tablets. Dose = 1 tablet daily until disease progression or intolerance
DRUG	Fulvestrant + Placebo	ZACTIMA Placebo 100 mg tablets. Dose = 1 tablet daily for duration of study.

Timeline

• Start date: 2009-08-01
• Primary completion: 2012-10-01
• Completion: 2013-08-01
• First posted: 2008-12-19
• Last updated: 2013-11-18

Locations

13 sites across 1 country: Canada