Breast Cancer Clinical Trial
Official title:
RADAR: A Randomized Discontinuation Phase II Study to Determine the Efficacy of RAD001 in Breast Cancer Patients With Bone Metastases
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.
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be withdrawn from the trial.
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