NCT00466102

Efficacy of RAD001 in Breast Cancer Patients With Bone Metastases

RADAR: A Randomized Discontinuation Phase II Study to Determine the Efficacy of RAD001 in Breast Cancer Patients With Bone Metastases

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: GBG Forschungs GmbH · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine wether RAD001 can inhibit growth of tumour cells and/or stop the formation and activity of bone degrading osteoclasts.

Detailed description

RAD001 is an orally bioavailable and well tolerated rapamycin ester analogue, which acts by selectively inhibiting mTOR (mammalian target of rapamycin). mTor is an intracellular protein kinase implicated in the control of cellular proliferation in neoplastic cells. Treatment with RAD001 has been shown to inhibit these signalling events and leads to growth retardation of tumour cells. In addition RAD001 in vitro stops the formation and activity of osteoclasts. Therefore a therapy of advanced breast cancer with progressive bone metastases seems to be reasonable with RAD001. Comparison: All patients receive RAD001 in an 8 week run in phase. Patients who show a response after 8 weeks will continue receiving RAD001. All patients with stable disease after the run in phase will be randomised to receive either RAD001 or placebo and will be followed up until progression of disease. Patients with progressive disease after the 8 week run in phase will be withdrawn from the trial.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	RAD001	Tablet of 5 mg, 2 tablets (10 mg) are taken once daily during study therapy
DRUG	Placebo	2 tablets are taken once daily during study therapy

Timeline

• Start date: 2006-12-01
• Primary completion: 2010-12-01
• Completion: 2012-12-01
• First posted: 2007-04-27
• Last updated: 2012-08-30

Locations

1 site across 1 country: Germany