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Efficacy of RAD001 in Breast Cancer Patients With Bone Metastases

2014-08-27 03:38:51 | BioPortfolio

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.

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 Patients with progressive disease after the 8 week run in phase will be withdrawn from the trial.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Conditions

Breast Cancer

Intervention

RAD001, Placebo

Location

Dr. med. Christoph Mundhenke
Kiel
Schleswig-Holstein
Germany
24105

Status

Recruiting

Source

German Breast Group

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:38:51-0400

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PubMed Articles [14684 Associated PubMed Articles listed on BioPortfolio]

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Medical and Biotech [MESH] Definitions

Abnormal accumulation of lymph in the arm, shoulder and breast area associated with surgical or radiation breast cancer treatments (e.g., MASTECTOMY).

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