Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
German Breast Group Novartis |
---|---|
Information provided by: | German Breast Group |
ClinicalTrials.gov Identifier: | NCT00466102 |
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.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Drug: RAD001 Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | RADAR: A Randomized Discontinuation Phase II Study to Determine the Efficacy of RAD001 in Breast Cancer Patients With Bone Metastases |
Estimated Enrollment: | 110 |
Study Start Date: | December 2006 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
Patients with stable disease after 8 week run in randomized to RAD001 (blinded)
|
Drug: RAD001
Tablet of 5 mg, 2 tablets (10 mg) are taken once daily during study therapy
|
2: Placebo Comparator
Patients with stable disease after 8 week run in receive placebo (blinded)
|
Drug: Placebo
2 tablets are taken once daily during study therapy
|
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 Patients with progressive disease after the 8 week run in phase will be withdrawn from the trial.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Konstantin Reißmüller | 0049-6102-7480 ext 438 | konstantin.reissmueller@germanbreastgroup.de |
Contact: Juliane Glötzner | 0049-6102-7480 ext 306 | radar@germanbreastgroup.de |
Germany, Schleswig-Holstein | |
Prof. Dr. med. Nicolai Maass | Recruiting |
Kiel, Schleswig-Holstein, Germany, 24105 |
Principal Investigator: | Nicolai Maass, MD | Universitätsfrauenklinik Kiel |
Responsible Party: | GBG Forschungs GmbH ( Dr. Sarah Burrack ) |
Study ID Numbers: | GBG 41 |
Study First Received: | April 25, 2007 |
Last Updated: | November 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00466102 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Breast Cancer Bone metastases as only metastatic site Breast cancer, HER2 negative Bone metastasis as only metastatic site |
Pretreated with endocrine therapy Up to one previous chemotherapy Previous treatment with bisphosphonates allowed |
Everolimus Diphosphonates Skin Diseases |
Neoplasm Metastasis Breast Neoplasms Breast Diseases |
Neoplastic Processes Neoplasms Pathologic Processes Neoplasms by Site |
Immunologic Factors Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions |